An environmental policy is a statement of the organization’s overall aims and principles ofaction with respect to the environment, including compliance with all relevant stakeholders. As such, it should be written clearly and concisely to enable a
regulatory requirements. It is a key tool in communicating the environmental priorities of your organization to employees at all levels, as well as to external layperson to understand it, and should be made publicly available. It is up to the organization to decide on environmental priorities based on an initial environmental review, but these choices should be justified in the policy. To be truly effective the policy should regularly be reviewed and revised and incorporated into the organization’s overall corporate policy. The policy statement should set in writing a few achievable quantifiable priorities related to the environmental management system and the significant environmental effects found at the work-site. Furthermore, EMAS requires that the most signifcant environmental effects be mitigated within three years. Some form of improvement must also be accomplished from year-to-year by the organization and must be shown in the annual reports.
Although the formulation of policies and clear priorities is the most important step of
environmental management, this step is often neglected. Many top managers feel pressure to do something for the environment and thus embark on some form of ?Environmental activism?E often containing many isolated activities but no clear direction. For an organization to be a credible and efficient environmental performer and to reap the benefits of being an environmental leader in its markets, the rationale for investing in environmental management must be very clear.
To ensure an organization’s commitment towards a formulated environmental policy, it is
essential that top management is involved in the process of formulating the policy and of setting priorities. Therefore the first step is to get the commitment from the highest level of management. Based on this commitment the organization should then conduct an initial environmental review and draft an environmental policy. This draft should be discussed and approved by the board of directors. Finally, the approved environmental policy statement must be communicated internally and made available to the public.
As the environmental policy establishes an overall sense of direction and sets the principles
of action for an organization, it requires commitment from the highest level of management. Top management should be involved in the development and adoption of an environmental policy.
Getting the commitment from the highest level should be argued on the basis of costs and the implementation of an EMS increases shareholder value it is easier for top
benefits and their impact on shareholder value. If management to commit themselves to approving an environmental policy and to implementing an environmental management system. This commitment includes three basic policy statements:
Continuous improvement in environmental performance
Compliance with environmental regulations
Maintaining public relations regarding environmental issues of the organization, its activities, products and services.
The central focus of the policy should be a commitment to continuous improvement. This
means improvement in the EMS itself and a decrease in environmental impacts caused by an organization’s activities, products and services. It is important for businesses to show improvement over time, both in environmental performance and in organizational commitment to this path.
A commitment to comply with at least local environmental regulations is a minimum
requirement for all of the environmental standards. However, multinationals operating in various environments and facing different laws in each, should think about which laws to abide by and if it is feasible to adopt the same standard worldwide. Generally, laws in newly industrializing countries are lax as compared to industrialized countries. However, given the increase in interest in environmental issues in these industrializing countries and the possible impact of the ISO 14000 series, it may be sound practice to adopt the more stringent laws in worldwide operations, where it is feasible to do so. In addition, the adoption of high standards worldwide can yield other benefits, such as an improved public image or easier technology transfer between different sites.
Companies should guard against going overboard in fulfilling environmental policies. Limits
are in fact set on how far a company has to go to reduce its environmental impacts. Reductions do not have to exceed levels which can be achieved by economically viable application of the best available technology (BAT).
Friday, October 9, 2009
Measurement and Evaluation In ISO 14001:2004
After implementing the environmental policy, management needs to measure environmental that the data can be verified by an internal or external auditor.
interventions and their impact on the environment. This is done by building up an environmental effects register (environmental inventory). All equipment used for monitoring and measuring must be accurate and calibrated on a regular basis. To check the compliance status of an organization, additional information about regulations and other requirements is needed. A so called environmental regulations register?Eis often installed and maintained for this purpose. To obtain a better picture about the financial consequences of environmental protection, the accounting system should reflect environmental costs. Therefore, information about environmentally-induced costs and earnings needs to be collected. All this information should be recorded in such a manner.er
Environmental Performance Evaluation Accesses Environment Performance against environmental targets and objectives and against applicable environmental regulations. Responsibilities and authority need to be defined to deal with non-compliance within the EMS. This includes specifying the actions to be taken to correct an undesirable ituation and to prevent future non-compliance.
The analysis of environmental and economic performance leads to eco efficiency, the key component in sustainable business management.
The analysis of environmental and economic performance leads to eco
efficiency, the key component in sustainable business management. The recording of physical environmental data, environmental regulations and environmentally-induced financial information is necessary as a basis for effective decision making. Therefore, financial, legal and ecological data systems must be built up from scratch or adapted to the requirements of the EMS standard.
interventions and their impact on the environment. This is done by building up an environmental effects register (environmental inventory). All equipment used for monitoring and measuring must be accurate and calibrated on a regular basis. To check the compliance status of an organization, additional information about regulations and other requirements is needed. A so called environmental regulations register?Eis often installed and maintained for this purpose. To obtain a better picture about the financial consequences of environmental protection, the accounting system should reflect environmental costs. Therefore, information about environmentally-induced costs and earnings needs to be collected. All this information should be recorded in such a manner.er
Environmental Performance Evaluation Accesses Environment Performance against environmental targets and objectives and against applicable environmental regulations. Responsibilities and authority need to be defined to deal with non-compliance within the EMS. This includes specifying the actions to be taken to correct an undesirable ituation and to prevent future non-compliance.
The analysis of environmental and economic performance leads to eco efficiency, the key component in sustainable business management.
The analysis of environmental and economic performance leads to eco
efficiency, the key component in sustainable business management. The recording of physical environmental data, environmental regulations and environmentally-induced financial information is necessary as a basis for effective decision making. Therefore, financial, legal and ecological data systems must be built up from scratch or adapted to the requirements of the EMS standard.
Basic QC and Six Sigma Tools
The 7 QC Tools
The Seven Quality Control tools (7QC tools) are graphical and statistical tools which are most often used in QC for continuous improvement. Since they are so widely utilized by almost every level of the company, they have been nicknamed the Magnificent Seven. They are applicable to improvements in all dimensions of the process performance triangle: variation of quality, cycle time and yield of productivity.
Each one of the 7QC tools had been used separately before 1960. However, in the early 1960s, they were gathered together by a small group of Japanese scientists lead by Kaoru Ishikawa, with the aim of providing the QC Circles with effective and easy-to-use tools. They are, in alphabetical order, cause-and-effect diagram, check sheet, control chart, histogram, Pareto chart, scatter diagram and stratification. In Six Sigma, they are extensively used in all phases of the improvement methodology – define, measure, analyze, improve and control.
(1) Cause-and-effect diagram
An effective tool as part of a problem-solving process is the cause-and-effect diagram, also known as the Ishikawa diagram (after its originator) or fishbone diagram. This technique is useful to trigger ideas and promote a balanced approach in group brainstorming sessions where individuals list the perceived sources (causes) with respect to outcomes (effect).
When constructing a cause-and-effect diagram, it is often appropriate to consider six main causes that can contribute to an outcome response (effect): so-called 5M1E (man, machine, material, method, measurement, and environment).
When preparing a cause-and-effect diagram, the first step is to agree on the specific wording of the effect and then to identify the main causes that can possibly produce the effect. The main causes can often be identified as any of 5M1E, which helps us to get started, but these are by no means exhaustive.
Using brainstorming techniques, each main cause is analyzed. The aim is to refine the list of causes in greater detail until the root causes of that particular main cause are established. The same procedure is then followed for each of the other main causes. The method is a main cause, the pressure and the temperature are the causes, and “the pressure is low” and “the temperature is too high” are the root causes.
(2) Check sheet
The check sheet is used for the specific data collection of any desired characteristics of a process or product that is to be improved. It is frequently used in the measure phase of the Six Sigma improvement methodology, DMAIC. For practical purposes, the check sheet is commonly formatted as a table. It is important that the check sheet is kept simple and that its design is aligned to the characteristics that are measured. Consideration should be given as to who should gather the data and what measurement intervals to apply. For example, Figure 4.2 shows a check sheet for defect items in an assembly process of automobile ratios.
(3) Control chart
(a) Introduction
The control chart is a very important tool in the “analyze, improve and control” phases of the Six Sigma improvement methodology. In the “analyze” phase, control charts are applied to judge if the process is predictable; in the “improve” phase, to identify evidence of special causes of variation so that they can be acted on; in the “control” phase, to verify that the performance of the process is under control.
The original concept of the control chart was proposed by Walter A. Shewhart in 1924 and the tool has been used extensively in industry since the Second World War, especially in Japan and the USA after about 1980. Control charts offer the study of variation and its source. They can give process monitoring and control, and can also give direction for improvements. They can separate special from common cause issues of a process. They can give early identification of special causes so that there can be timely resolution before many poor quality products are produced. Shewhart control charts track processes by plotting data over time in the form shown in Figure 4.3. This chart can track either variables or attribute process parameters. The types of variable charts are process mean (x), range (R), standard deviation (s), individual value (x) and moving range (Rs). The attribute types are fraction nonconforming (p), number of nonconforming items (np), number of nonconformities (c), and nonconformities per unit (u).
(4) Histogram
It is meaningful to present data in a form that visually illustrates the frequency of occurrence of values. In the analysis phase of the Six Sigma improvement methodology, histograms are commonly applied to learn about the distribution of the data within the results Ys and the causes Xs collected in the measure phase and they are also used to obtain an understanding of the potential for improvements.
(5) Pareto chart
The Pareto chart was introduced in the 1940s by Joseph M.Juran, who named it after the Italian economist and statistician Vilfredo Pareto, 1848–1923. It is applied to distinguish the “vital few from the trivial many” as Juran formulated the purpose of the Pareto chart. It is closely related to the so-called 80/20 rule – “80% of the problems stem from 20% of the causes,” or in Six Sigma terms “80% of the poor values in Y stem from 20% of the Xs.”
In the Six Sigma improvement methodology, the Pareto chart has two primary applications. One is for selecting appropriate improvement projects in the define phase. Here it offers a very objective basis for selection, based on, for example, frequency of occurrence, cost saving and improvement potential in process performance.
The other primary application is in the analyze phase for identifying the vital few causes (Xs) that will constitute the greatest improvement in Y if appropriate measures are taken.
A procedure to construct a Pareto chart is as follows:
1) Define the problem and process characteristics to use in the diagram.
2) Define the period of time for the diagram – for example, weekly, daily, or shift.
Quality improvements over time can later be made from the information determined within this step.
3) Obtain the total number of times each characteristic occurred.
4) Rank the characteristics according to the totals from
(6) Scatter diagram
The scatter plot is a useful way to discover the relationship between two factors, X and Y, i.e., the correlation. An important feature of the scatter plot is its visualization of the correlation pattern, through which the relationship can be determined. In the improve phase of the Six Sigma improvement methodology, one often searches the collected data for Xs that have a special influence on Y. Knowing the existence of such relationships, it is possible to identify input variables that
cause special variation of the result variable. It can then be determined how to set the input variables, if they are controllable, so that the process is improved. When several Xs may influence the values of Y, one scatter plot should be drawn for each combination of the Xs and Y.
(7) Stratification
Stratification is a tool used to split collected data into subgroups in order to determine if any of them contain special cause variation. Hence, data from different sources in a process can be separated and analyzed individually. Stratification is mainly used in the analyze phase to stratify data in the
search for special cause variation in the Six Sigma improvement methodology.
The most important decision in using stratification is to determine the criteria by which to stratify. Examples can be machines, material, suppliers, shifts, day and night, age groups and so on. It is common to stratify into two groups. If the number of observations is large enough, more detailed stratification is also possible.
The Seven Quality Control tools (7QC tools) are graphical and statistical tools which are most often used in QC for continuous improvement. Since they are so widely utilized by almost every level of the company, they have been nicknamed the Magnificent Seven. They are applicable to improvements in all dimensions of the process performance triangle: variation of quality, cycle time and yield of productivity.
Each one of the 7QC tools had been used separately before 1960. However, in the early 1960s, they were gathered together by a small group of Japanese scientists lead by Kaoru Ishikawa, with the aim of providing the QC Circles with effective and easy-to-use tools. They are, in alphabetical order, cause-and-effect diagram, check sheet, control chart, histogram, Pareto chart, scatter diagram and stratification. In Six Sigma, they are extensively used in all phases of the improvement methodology – define, measure, analyze, improve and control.
(1) Cause-and-effect diagram
An effective tool as part of a problem-solving process is the cause-and-effect diagram, also known as the Ishikawa diagram (after its originator) or fishbone diagram. This technique is useful to trigger ideas and promote a balanced approach in group brainstorming sessions where individuals list the perceived sources (causes) with respect to outcomes (effect).
When constructing a cause-and-effect diagram, it is often appropriate to consider six main causes that can contribute to an outcome response (effect): so-called 5M1E (man, machine, material, method, measurement, and environment).
When preparing a cause-and-effect diagram, the first step is to agree on the specific wording of the effect and then to identify the main causes that can possibly produce the effect. The main causes can often be identified as any of 5M1E, which helps us to get started, but these are by no means exhaustive.
Using brainstorming techniques, each main cause is analyzed. The aim is to refine the list of causes in greater detail until the root causes of that particular main cause are established. The same procedure is then followed for each of the other main causes. The method is a main cause, the pressure and the temperature are the causes, and “the pressure is low” and “the temperature is too high” are the root causes.
(2) Check sheet
The check sheet is used for the specific data collection of any desired characteristics of a process or product that is to be improved. It is frequently used in the measure phase of the Six Sigma improvement methodology, DMAIC. For practical purposes, the check sheet is commonly formatted as a table. It is important that the check sheet is kept simple and that its design is aligned to the characteristics that are measured. Consideration should be given as to who should gather the data and what measurement intervals to apply. For example, Figure 4.2 shows a check sheet for defect items in an assembly process of automobile ratios.
(3) Control chart
(a) Introduction
The control chart is a very important tool in the “analyze, improve and control” phases of the Six Sigma improvement methodology. In the “analyze” phase, control charts are applied to judge if the process is predictable; in the “improve” phase, to identify evidence of special causes of variation so that they can be acted on; in the “control” phase, to verify that the performance of the process is under control.
The original concept of the control chart was proposed by Walter A. Shewhart in 1924 and the tool has been used extensively in industry since the Second World War, especially in Japan and the USA after about 1980. Control charts offer the study of variation and its source. They can give process monitoring and control, and can also give direction for improvements. They can separate special from common cause issues of a process. They can give early identification of special causes so that there can be timely resolution before many poor quality products are produced. Shewhart control charts track processes by plotting data over time in the form shown in Figure 4.3. This chart can track either variables or attribute process parameters. The types of variable charts are process mean (x), range (R), standard deviation (s), individual value (x) and moving range (Rs). The attribute types are fraction nonconforming (p), number of nonconforming items (np), number of nonconformities (c), and nonconformities per unit (u).
(4) Histogram
It is meaningful to present data in a form that visually illustrates the frequency of occurrence of values. In the analysis phase of the Six Sigma improvement methodology, histograms are commonly applied to learn about the distribution of the data within the results Ys and the causes Xs collected in the measure phase and they are also used to obtain an understanding of the potential for improvements.
(5) Pareto chart
The Pareto chart was introduced in the 1940s by Joseph M.Juran, who named it after the Italian economist and statistician Vilfredo Pareto, 1848–1923. It is applied to distinguish the “vital few from the trivial many” as Juran formulated the purpose of the Pareto chart. It is closely related to the so-called 80/20 rule – “80% of the problems stem from 20% of the causes,” or in Six Sigma terms “80% of the poor values in Y stem from 20% of the Xs.”
In the Six Sigma improvement methodology, the Pareto chart has two primary applications. One is for selecting appropriate improvement projects in the define phase. Here it offers a very objective basis for selection, based on, for example, frequency of occurrence, cost saving and improvement potential in process performance.
The other primary application is in the analyze phase for identifying the vital few causes (Xs) that will constitute the greatest improvement in Y if appropriate measures are taken.
A procedure to construct a Pareto chart is as follows:
1) Define the problem and process characteristics to use in the diagram.
2) Define the period of time for the diagram – for example, weekly, daily, or shift.
Quality improvements over time can later be made from the information determined within this step.
3) Obtain the total number of times each characteristic occurred.
4) Rank the characteristics according to the totals from
(6) Scatter diagram
The scatter plot is a useful way to discover the relationship between two factors, X and Y, i.e., the correlation. An important feature of the scatter plot is its visualization of the correlation pattern, through which the relationship can be determined. In the improve phase of the Six Sigma improvement methodology, one often searches the collected data for Xs that have a special influence on Y. Knowing the existence of such relationships, it is possible to identify input variables that
cause special variation of the result variable. It can then be determined how to set the input variables, if they are controllable, so that the process is improved. When several Xs may influence the values of Y, one scatter plot should be drawn for each combination of the Xs and Y.
(7) Stratification
Stratification is a tool used to split collected data into subgroups in order to determine if any of them contain special cause variation. Hence, data from different sources in a process can be separated and analyzed individually. Stratification is mainly used in the analyze phase to stratify data in the
search for special cause variation in the Six Sigma improvement methodology.
The most important decision in using stratification is to determine the criteria by which to stratify. Examples can be machines, material, suppliers, shifts, day and night, age groups and so on. It is common to stratify into two groups. If the number of observations is large enough, more detailed stratification is also possible.
TQM and Six Sigma
While Six Sigma is definitely succeeding in creating some impressive results and culture changes in some influential organizations, it is certainly not yet a widespread success. Total Quality Management (TQM) seems less visible in many businesses than it was in the early 1990s. However, many companies are still engaged in improvement efforts based on the principles and tools of TQM. It appears at least in Korea that Six Sigma is succeeding while TQM is losing its momentum.
One of the problems that plagued many of the early TQM initiatives was the preeminence placed on quality at the expense of all other aspects of the business. Some organizations experienced severe financial consequences in the rush to make quality “first among equals.” The disconnection between management systems designed to measure customer satisfaction and those designed to measure provider profitability often led to unwise investments in quality, which has been often practiced in TQM. Ronald Snee (1999) points out that although some people believe it is nothing new, Six Sigma is unique in its approach and deployment. He defines Six Sigma as a strategic business improvement approach that seeks to increase both customer satisfaction and an organization’s financial health. Snee goes on to claim that the following eight characteristics account for Six Sigma’s increasing bottom-line (net income or profit) success and popularity with executives.
• Bottom-line results expected and delivered
• Senior management leadership
• A disciplined approach (DMAIC)
• Rapid (3–6 months) project completion
• Clearly defined measures of success
• Infrastructure roles for Six Sigma practitioners and leadership
• Focus on customers and processes
• A sound statistical approach to improvement
Other quality initiatives including TQM have laid claim to a subset of these characteristics, but only Six Sigma attributes its success to the simultaneous application of all eight. Six Sigma is regarded as a vigorous rebirth of quality ideals and methods, as these are applied with even greater passion and commitment than often was the case in the past. Six Sigma is revealing a potential for success that goes beyond the levels of improvement achieved through the many TQM efforts. Some of the mistakes of yesterday’s TQM efforts certainly might be repeated in a Six Sigma initiative if we are not careful.
A review of some of the major TQM pitfalls, as well as hints on how the Six Sigma system can keep them from derailing our efforts is listed below.
1. Links to the business and bottom-line success:
In TQM, quality often was a “sidebar” activity, separated from the key issues of business strategy and performance. The link to the business and bottom-line success was undermined, despite the term “total” quality, since the effort actually was limited to product and manufacturing functions. Six Sigma emphasizes reduction of costs, thereby contributing to the bottom-line, and participation of three major areas: manufacturing, R&D and service parts.
2. Top-level management leadership:
In many TQM efforts, top-level management’s skepticism has been apparent, or their willingness to drive quality ideas has been weak. Passion for and belief in Six Sigma at the very summit of the business is unquestioned in companies like
Motorola, GE, Allied Signal (now Honeywell), LG and Samsung. In fact, top-level management involvement is the beginning of Six Sigma.
3. Clear and simple message:
The fuzziness of TQM started with the word “quality” itself. It is a familiar term with many shades of meaning. In many companies, Quality was an existing department with specific responsibilities for “quality control” or “quality assurance,” where the discipline tended to focus more on stabilizing rather than improving processes. Also TQM does not provide a clear goal at which to aim. The concept of Six Sigma is clear and simple. It is a business system for achieving and sustaining success through customer focus, process management and improvement, and the wise use of facts and data. A clear goal (3. 4 DPMO or 6s quality level) is the centerpiece of Six Sigma.
4. Effective training:
TQM training was ineffective in the sense that the training program was not so systematic. Six Sigma divides all the employees into five groups (WB, GB, BB, MBB and Champion), and it sets very demanding standards for learning, backing them up with the necessary investment in time and money to help people meet those standards.
5. Internal barriers:
TQM was a mostly “departmentalized” activity in many companies, and it seemed that TQM failed to break down internal barriers among departments. Six Sigma places priority on cross-functional process management, and cross-functional project teams are created, which eventually breaks down internal barriers.
6. Project team activities:
TQM utilized many “quality circles” of blue-collar operators and workers, and not many “task force teams” of white-collar engineers even if they are needed. Six Sigma demands a lot of project teams of BBs and GBs, and the project team activities are one of the major sources of bottom-line and top-line success.
3. Clear and simple message:
The fuzziness of TQM started with the word “quality” itself. It is a familiar term with many shades of meaning. In many companies, Quality was an existing department with specific responsibilities for “quality control” or “quality assurance,” where the discipline tended to focus more on stabilizing rather than improving processes. Also TQM does not provide a clear goal at which to aim. The concept of Six Sigma is clear and simple. It is a business system for achieving and sustaining success through customer focus, process management and improvement, and the wise use of facts and data. A clear goal (3. 4 DPMO or 6s quality level) is the centerpiece of Six Sigma.
4. Effective training:
TQM training was ineffective in the sense that the training program was not so systematic. Six Sigma divides all the employees into five groups (WB, GB, BB, MBB and Champion), and it sets very demanding standards for learning, backing them up with the necessary investment in time and money
to help people meet those standards.
5. Internal barriers:
TQM was a mostly “departmentalized” activity in many companies, and it seemed that TQM failed to break down internal barriers among departments. Six Sigma places priority on cross-functional process management, and cross-functional project teams are created, which eventually breaks down internal barriers.
6. Project team activities:
TQM utilized many “quality circles” of blue-collar operators and workers, and not many “task force teams” of white-collar engineers even if they are needed. Six Sigma demands a lot of project teams of BBs and GBs, and the project team activities are one of the major sources of bottom-line and top-line success.
One of the problems that plagued many of the early TQM initiatives was the preeminence placed on quality at the expense of all other aspects of the business. Some organizations experienced severe financial consequences in the rush to make quality “first among equals.” The disconnection between management systems designed to measure customer satisfaction and those designed to measure provider profitability often led to unwise investments in quality, which has been often practiced in TQM. Ronald Snee (1999) points out that although some people believe it is nothing new, Six Sigma is unique in its approach and deployment. He defines Six Sigma as a strategic business improvement approach that seeks to increase both customer satisfaction and an organization’s financial health. Snee goes on to claim that the following eight characteristics account for Six Sigma’s increasing bottom-line (net income or profit) success and popularity with executives.
• Bottom-line results expected and delivered
• Senior management leadership
• A disciplined approach (DMAIC)
• Rapid (3–6 months) project completion
• Clearly defined measures of success
• Infrastructure roles for Six Sigma practitioners and leadership
• Focus on customers and processes
• A sound statistical approach to improvement
Other quality initiatives including TQM have laid claim to a subset of these characteristics, but only Six Sigma attributes its success to the simultaneous application of all eight. Six Sigma is regarded as a vigorous rebirth of quality ideals and methods, as these are applied with even greater passion and commitment than often was the case in the past. Six Sigma is revealing a potential for success that goes beyond the levels of improvement achieved through the many TQM efforts. Some of the mistakes of yesterday’s TQM efforts certainly might be repeated in a Six Sigma initiative if we are not careful.
A review of some of the major TQM pitfalls, as well as hints on how the Six Sigma system can keep them from derailing our efforts is listed below.
1. Links to the business and bottom-line success:
In TQM, quality often was a “sidebar” activity, separated from the key issues of business strategy and performance. The link to the business and bottom-line success was undermined, despite the term “total” quality, since the effort actually was limited to product and manufacturing functions. Six Sigma emphasizes reduction of costs, thereby contributing to the bottom-line, and participation of three major areas: manufacturing, R&D and service parts.
2. Top-level management leadership:
In many TQM efforts, top-level management’s skepticism has been apparent, or their willingness to drive quality ideas has been weak. Passion for and belief in Six Sigma at the very summit of the business is unquestioned in companies like
Motorola, GE, Allied Signal (now Honeywell), LG and Samsung. In fact, top-level management involvement is the beginning of Six Sigma.
3. Clear and simple message:
The fuzziness of TQM started with the word “quality” itself. It is a familiar term with many shades of meaning. In many companies, Quality was an existing department with specific responsibilities for “quality control” or “quality assurance,” where the discipline tended to focus more on stabilizing rather than improving processes. Also TQM does not provide a clear goal at which to aim. The concept of Six Sigma is clear and simple. It is a business system for achieving and sustaining success through customer focus, process management and improvement, and the wise use of facts and data. A clear goal (3. 4 DPMO or 6s quality level) is the centerpiece of Six Sigma.
4. Effective training:
TQM training was ineffective in the sense that the training program was not so systematic. Six Sigma divides all the employees into five groups (WB, GB, BB, MBB and Champion), and it sets very demanding standards for learning, backing them up with the necessary investment in time and money to help people meet those standards.
5. Internal barriers:
TQM was a mostly “departmentalized” activity in many companies, and it seemed that TQM failed to break down internal barriers among departments. Six Sigma places priority on cross-functional process management, and cross-functional project teams are created, which eventually breaks down internal barriers.
6. Project team activities:
TQM utilized many “quality circles” of blue-collar operators and workers, and not many “task force teams” of white-collar engineers even if they are needed. Six Sigma demands a lot of project teams of BBs and GBs, and the project team activities are one of the major sources of bottom-line and top-line success.
3. Clear and simple message:
The fuzziness of TQM started with the word “quality” itself. It is a familiar term with many shades of meaning. In many companies, Quality was an existing department with specific responsibilities for “quality control” or “quality assurance,” where the discipline tended to focus more on stabilizing rather than improving processes. Also TQM does not provide a clear goal at which to aim. The concept of Six Sigma is clear and simple. It is a business system for achieving and sustaining success through customer focus, process management and improvement, and the wise use of facts and data. A clear goal (3. 4 DPMO or 6s quality level) is the centerpiece of Six Sigma.
4. Effective training:
TQM training was ineffective in the sense that the training program was not so systematic. Six Sigma divides all the employees into five groups (WB, GB, BB, MBB and Champion), and it sets very demanding standards for learning, backing them up with the necessary investment in time and money
to help people meet those standards.
5. Internal barriers:
TQM was a mostly “departmentalized” activity in many companies, and it seemed that TQM failed to break down internal barriers among departments. Six Sigma places priority on cross-functional process management, and cross-functional project teams are created, which eventually breaks down internal barriers.
6. Project team activities:
TQM utilized many “quality circles” of blue-collar operators and workers, and not many “task force teams” of white-collar engineers even if they are needed. Six Sigma demands a lot of project teams of BBs and GBs, and the project team activities are one of the major sources of bottom-line and top-line success.
ISO 9000 Series and Six Sigma
ISO (International Organization for Standardization) 9000 series standards were first published in 1987, revised in 1994, and re-revised in 2000 by the ISO. The 2000 revision, denoted by ISO 9000:2000, has attracted broad expectations in industry.
As of the year 2001, more than 300,000 organizations world-wide have been certified to the ISO 9000 series standards. It embodies a consistent pair of standards, ISO 9001:2000 and ISO 9004:2000, both of which have been significantly updated and modernized. The ISO 9001:2000 standard specifies requirements for a quality management system for which third-party certification is possible, whereas ISO 9004:2000 provides guide- lines for a comprehensive quality management system and performance improvement through Self-Assessment.
The origin and historical development of ISO 9000 and Six Sigma are very different. The genesis of ISO 9000 can be traced back to the standards that the British aviation industry and the U.S. Air Force developed in the 1920s to reduce the need for inspection by approving the conformance of suppliers’ product quality. These standards developed into requirements for suppliers’ quality assurance systems in a number of western countries in the 1970s. In 1987 they were amalgamated into the ISO 9000 series standards.
Independent of ISO 9000, the same year also saw the launch of Six Sigma at Motorola and the launch of Self-Assessment by means of the Malcolm Baldrige National Quality Award in USA. Both Six Sigma and Self-Assessment can be traced back to Walter A. Shewhart and his work on variation and continuous improvement in the 1920s. It was Japanese industry that pioneered a broad application of these ideas from the 1950s through to the 1970s. When variation and continuous improvement caught the attention of some of the American business leaders in the late 1980s, it took the form of the Malcolm Baldrige National Quality Award, on a national level, and of Six Sigma at Motorola.
Some people are wondering if the ISO 9000:2000 series standards make Six Sigma superfluous. They typically refer to clause 8 of ISO 9001: “Measurement, analysis, improvement.”
It requires that companies install procedures in operations for the measurement of processes and data analysis using statistical techniques with the demonstration of continuous improvement . They also partly refer to the ISO 9004:2000 standards that embody guidelines and criteria for Self-Assessment similar to the national quality awards.
The author firmly believes that Six Sigma is needed regardless of whether a company is compliant with the ISO 9000 series. The two initiatives are not mutually exclusive and the objectives in applying them are different. A Six Sigma program is applied in organizations based on its top-line and bottom-line rationales. The primary objective for applying the ISO 9000 series standards is to demonstrate the company’s capability to consistently provide conforming products and/or services. Therefore, the ISO 9000 series standard falls well short of making Six Sigma superfluous.
The ISO 9000 series standards have from their early days been regarded and practiced by industry as a minimum set of requirements for doing business. The new ISO 9000:2000 stan
dards do not represent a significant change to this perspective. Six Sigma on the other hand, aims at world-class performance, based on a pragmatic framework for continuous improvement.
The author believes that Six Sigma is superior in such important areas as rate of improvement, bottom-line and top-line results, customer satisfaction, and top-level management commitment. However, considering the stronghold of ISO 9000 in industry, Six Sigma and ISO 9000 are likely to be applied by the same organization, but for very different purposes.
As of the year 2001, more than 300,000 organizations world-wide have been certified to the ISO 9000 series standards. It embodies a consistent pair of standards, ISO 9001:2000 and ISO 9004:2000, both of which have been significantly updated and modernized. The ISO 9001:2000 standard specifies requirements for a quality management system for which third-party certification is possible, whereas ISO 9004:2000 provides guide- lines for a comprehensive quality management system and performance improvement through Self-Assessment.
The origin and historical development of ISO 9000 and Six Sigma are very different. The genesis of ISO 9000 can be traced back to the standards that the British aviation industry and the U.S. Air Force developed in the 1920s to reduce the need for inspection by approving the conformance of suppliers’ product quality. These standards developed into requirements for suppliers’ quality assurance systems in a number of western countries in the 1970s. In 1987 they were amalgamated into the ISO 9000 series standards.
Independent of ISO 9000, the same year also saw the launch of Six Sigma at Motorola and the launch of Self-Assessment by means of the Malcolm Baldrige National Quality Award in USA. Both Six Sigma and Self-Assessment can be traced back to Walter A. Shewhart and his work on variation and continuous improvement in the 1920s. It was Japanese industry that pioneered a broad application of these ideas from the 1950s through to the 1970s. When variation and continuous improvement caught the attention of some of the American business leaders in the late 1980s, it took the form of the Malcolm Baldrige National Quality Award, on a national level, and of Six Sigma at Motorola.
Some people are wondering if the ISO 9000:2000 series standards make Six Sigma superfluous. They typically refer to clause 8 of ISO 9001: “Measurement, analysis, improvement.”
It requires that companies install procedures in operations for the measurement of processes and data analysis using statistical techniques with the demonstration of continuous improvement . They also partly refer to the ISO 9004:2000 standards that embody guidelines and criteria for Self-Assessment similar to the national quality awards.
The author firmly believes that Six Sigma is needed regardless of whether a company is compliant with the ISO 9000 series. The two initiatives are not mutually exclusive and the objectives in applying them are different. A Six Sigma program is applied in organizations based on its top-line and bottom-line rationales. The primary objective for applying the ISO 9000 series standards is to demonstrate the company’s capability to consistently provide conforming products and/or services. Therefore, the ISO 9000 series standard falls well short of making Six Sigma superfluous.
The ISO 9000 series standards have from their early days been regarded and practiced by industry as a minimum set of requirements for doing business. The new ISO 9000:2000 stan
dards do not represent a significant change to this perspective. Six Sigma on the other hand, aims at world-class performance, based on a pragmatic framework for continuous improvement.
The author believes that Six Sigma is superior in such important areas as rate of improvement, bottom-line and top-line results, customer satisfaction, and top-level management commitment. However, considering the stronghold of ISO 9000 in industry, Six Sigma and ISO 9000 are likely to be applied by the same organization, but for very different purposes.
Lean Manufacturing and Six Sigma
(1) What is lean manufacturing?
Currently there are two premier approaches to improving manufacturing operations. One is lean manufacturing (hereinafter referred to as “lean”) and the other is Six Sigma.
Lean evaluates the entire operation of a factory and restructures the manufacturing method to reduce wasteful activities like waiting, transportation, material hand-offs,inventory, and over-production. It reduces variation associated with manufacturing routings, material handling, storage, lack of communication, batch production and so forth. Six Sigma tools, on the other hand, commonly focus on specific part numbers and processes to reduce variation. The combination of the two approaches represents a formidable opponent to variation in that it includes both layout of the factory and a focus on specific part numbers and processes.
Lean and Six Sigma are promoted as different approaches and different thought processes. Yet, upon close inspection, both approaches attack the same enemy and behave like two links within a chain – that is, they are dependent on each other for success. They both battle variation, but from two different points of view. The integration of Lean and Six Sigma takes two powerful problem-solving techniques and bundles them into a powerful package. The two approaches should be viewed as complements to each other rather than as equiva
lents of or replacements for each other (Pyzdek, 2000). In practice, manufacturers that have widely adopted lean practices record performance metrics superior to those achieved by plants that have not adopted lean practices. Those practices cited as lean in a recent industrial survey (Jusko, 1999) include
• quick changeover techniques to reduce setup time;
• adoption of manufacturing cells in which equipment and workstations are arranged sequentially to facilitate small-lot, continuous-flow production;
• just-in-time (JIT) continuous-flow production techniques to reduce lot sizes, setup time, and cycle time; and,
• JIT supplier delivery in which parts and materials are delivered to the shop floor on a frequent and as-needed basis.
(2) Differences between Lean and Six Sigma
There are some differences between Lean and Six Sigma as noted below.
• Lean focuses on improving manufacturing operations in variation, quality and productivity. However, Six Sigma focuses not only on manufacturing operations, but also on all possible processes including R&D and service areas.
• Generally speaking, a Lean approach attacks variation differently than a Six Sigma system does (Denecke, 1998) as shown in Figure 5.4. Lean tackles the most common form of process noise by aligning the organization in such a way that it can begin working as a coherent whole instead of as separate units. Lean seeks to co-locate, in sequential order, all the processes required to produce a product. Instead of focusing on the part number, Lean focuses on product flow and on the operator. Setup time, machine maintenance and routing of processes are important measures in Lean. However, Six Sigma focuses on defective rates and costs of poor quality due to part variation and process variation based on measured data.
• The data-driven nature of Six Sigma problem-solving lends itself well to lean standardization and the physical rearrangement of the factory. Lean provides a solid foundation for Six Sigma problem-solving where the system is measured by deviation from and improvements to the standard.
• While Lean emphasizes standardization and productivity, Six Sigma can be more effective at tackling process noise and cost of poor quality.
Currently there are two premier approaches to improving manufacturing operations. One is lean manufacturing (hereinafter referred to as “lean”) and the other is Six Sigma.
Lean evaluates the entire operation of a factory and restructures the manufacturing method to reduce wasteful activities like waiting, transportation, material hand-offs,inventory, and over-production. It reduces variation associated with manufacturing routings, material handling, storage, lack of communication, batch production and so forth. Six Sigma tools, on the other hand, commonly focus on specific part numbers and processes to reduce variation. The combination of the two approaches represents a formidable opponent to variation in that it includes both layout of the factory and a focus on specific part numbers and processes.
Lean and Six Sigma are promoted as different approaches and different thought processes. Yet, upon close inspection, both approaches attack the same enemy and behave like two links within a chain – that is, they are dependent on each other for success. They both battle variation, but from two different points of view. The integration of Lean and Six Sigma takes two powerful problem-solving techniques and bundles them into a powerful package. The two approaches should be viewed as complements to each other rather than as equiva
lents of or replacements for each other (Pyzdek, 2000). In practice, manufacturers that have widely adopted lean practices record performance metrics superior to those achieved by plants that have not adopted lean practices. Those practices cited as lean in a recent industrial survey (Jusko, 1999) include
• quick changeover techniques to reduce setup time;
• adoption of manufacturing cells in which equipment and workstations are arranged sequentially to facilitate small-lot, continuous-flow production;
• just-in-time (JIT) continuous-flow production techniques to reduce lot sizes, setup time, and cycle time; and,
• JIT supplier delivery in which parts and materials are delivered to the shop floor on a frequent and as-needed basis.
(2) Differences between Lean and Six Sigma
There are some differences between Lean and Six Sigma as noted below.
• Lean focuses on improving manufacturing operations in variation, quality and productivity. However, Six Sigma focuses not only on manufacturing operations, but also on all possible processes including R&D and service areas.
• Generally speaking, a Lean approach attacks variation differently than a Six Sigma system does (Denecke, 1998) as shown in Figure 5.4. Lean tackles the most common form of process noise by aligning the organization in such a way that it can begin working as a coherent whole instead of as separate units. Lean seeks to co-locate, in sequential order, all the processes required to produce a product. Instead of focusing on the part number, Lean focuses on product flow and on the operator. Setup time, machine maintenance and routing of processes are important measures in Lean. However, Six Sigma focuses on defective rates and costs of poor quality due to part variation and process variation based on measured data.
• The data-driven nature of Six Sigma problem-solving lends itself well to lean standardization and the physical rearrangement of the factory. Lean provides a solid foundation for Six Sigma problem-solving where the system is measured by deviation from and improvements to the standard.
• While Lean emphasizes standardization and productivity, Six Sigma can be more effective at tackling process noise and cost of poor quality.
Seven Steps for Six Sigma Introduction
When a company intends to introduce Six Sigma for its new management strategy, we would like to recommend the following seven-step procedures:
1. Top-level management commitment for Six Sigma is first and foremost. The CEO of the corporation or business unit should genuinely accept Six Sigma as the management strategy. Then organize a Six Sigma team and set up the long-term Six Sigma vision for the company.
2. Start Six Sigma education for Champions first. Then start the education for WBs, GBs, BBs and MBBs in sequence. Every employee of the company should take the WB education first and then some of the WBs receive the GB education, and finally some of the GBs receive the BB education. However, usually MBB education is practiced in professional organizations.
3. Choose the area in which Six Sigma will be first introduced.
4. Deploy CTQs for all processes concerned. The most important is the company’s deployment of big CTQy from the standpoint of customer satisfaction. Appoint BBs as full-time project leaders and ask them to solve some important CTQ problems.
5. Strengthen the infrastructure for Six Sigma, including measurement systems, statistical process control (SPC), knowledge management (KM), database management system (DBMS) and so on.
6. Designate a Six Sigma day each month, and have the progress of Six Sigma reviewed by top-level management.
7. Evaluate the company’s Six Sigma performance from the customers’ viewpoint, benchmark the best company in the world, and revise the Six Sigma roadmap if necessary. Go to step 1 for further improvement.
First of all, a handful or a group of several members should be appointed as a Six Sigma team to handle all kinds of Six Sigma tasks. The team is supposed to prepare proper education and the long-term Six Sigma vision for the company. We can say that this is the century of the 3Cs, which are Changing society, Customer satisfaction and Competition in quality. The Six Sigma vision should be well matched to these 3Cs. Most importantly, all employees in the company should agree to and respect this long-term vision.
Second, Six Sigma can begin from proper education for all classes of the company. The education should begin from the top managers, so called Champions. If Champions do not understand the real meaning of Six Sigma, there is no way for Six Sigma to proceed further in the company. After Champion’s education, GB BB MBB education should be completed in sequence.
Third, we can divide Six Sigma into three parts according to its characteristics. They are R&D Six Sigma, manufacturing Six Sigma, and Six Sigma for non-manufacturing areas. The R&D Six Sigma is often called DFSS (Design for Six Sigma). It is usually not wise to introduce Six Sigma to all areas at the same time. The CEO should decide the order of introduction to these three areas. It is common to introduce Six Sigma to manufacturing processes first, and then service areas and R&D areas. However, the order really depends on the current circumstances of the company.
Fourth, deploy CTQs for all processes concerned. These CTQs can be deployed by policy management or by management by objectives. Some important CTQs should be given to BBs to solve as project themes. In principle, the BBs who lead the project teams work as full-time workers until the projects are finished.
1. Top-level management commitment for Six Sigma is first and foremost. The CEO of the corporation or business unit should genuinely accept Six Sigma as the management strategy. Then organize a Six Sigma team and set up the long-term Six Sigma vision for the company.
2. Start Six Sigma education for Champions first. Then start the education for WBs, GBs, BBs and MBBs in sequence. Every employee of the company should take the WB education first and then some of the WBs receive the GB education, and finally some of the GBs receive the BB education. However, usually MBB education is practiced in professional organizations.
3. Choose the area in which Six Sigma will be first introduced.
4. Deploy CTQs for all processes concerned. The most important is the company’s deployment of big CTQy from the standpoint of customer satisfaction. Appoint BBs as full-time project leaders and ask them to solve some important CTQ problems.
5. Strengthen the infrastructure for Six Sigma, including measurement systems, statistical process control (SPC), knowledge management (KM), database management system (DBMS) and so on.
6. Designate a Six Sigma day each month, and have the progress of Six Sigma reviewed by top-level management.
7. Evaluate the company’s Six Sigma performance from the customers’ viewpoint, benchmark the best company in the world, and revise the Six Sigma roadmap if necessary. Go to step 1 for further improvement.
First of all, a handful or a group of several members should be appointed as a Six Sigma team to handle all kinds of Six Sigma tasks. The team is supposed to prepare proper education and the long-term Six Sigma vision for the company. We can say that this is the century of the 3Cs, which are Changing society, Customer satisfaction and Competition in quality. The Six Sigma vision should be well matched to these 3Cs. Most importantly, all employees in the company should agree to and respect this long-term vision.
Second, Six Sigma can begin from proper education for all classes of the company. The education should begin from the top managers, so called Champions. If Champions do not understand the real meaning of Six Sigma, there is no way for Six Sigma to proceed further in the company. After Champion’s education, GB BB MBB education should be completed in sequence.
Third, we can divide Six Sigma into three parts according to its characteristics. They are R&D Six Sigma, manufacturing Six Sigma, and Six Sigma for non-manufacturing areas. The R&D Six Sigma is often called DFSS (Design for Six Sigma). It is usually not wise to introduce Six Sigma to all areas at the same time. The CEO should decide the order of introduction to these three areas. It is common to introduce Six Sigma to manufacturing processes first, and then service areas and R&D areas. However, the order really depends on the current circumstances of the company.
Fourth, deploy CTQs for all processes concerned. These CTQs can be deployed by policy management or by management by objectives. Some important CTQs should be given to BBs to solve as project themes. In principle, the BBs who lead the project teams work as full-time workers until the projects are finished.
Thursday, October 8, 2009
Useful Aids to Implement ISO 9001 Standards
Useful Aids To Implement ISO 9001 Standards
Many companies implement ISO 9001 without using all the available tools. As a result, some companies may not fully optimize their implementation. This issue could be manifested as confusion over terms, misunderstanding about requirements, and perplexity concerning intention.ISO, the International Organization for Standardization, based in Geneva Switzerland issues thousands of standards, but we limit our scope to ISO 9001:2008 and its immediate “family”.This includes ISO 9000:2005 and ISO 9004:20002. ISO 9001 is a general industry standard for quality management, but ISO also issues industry specific standards. Many of these standards, such as ISO 13485 for medical devices, are based on ISO 9001 and can also utilize these available tools.
In addition to the information discussed below, ISO also issues standards related to specific activities that may arises in a quality management system. The following lists these supporting documents.
Automotive ISO/TS 16949:2002Education IWA 2:2007Energy PC 242, ISO 50001Food safety ISO 22000:2005Information security ISO/IEC 27001:2005Health care IWA 1:2005Local government IWA 4:2005Medical devices ISO 13485:2003Petroleum and gas ISO 29001:2003Ship recycling ISO/PAS 30000:2008Supply chain security ISO 28000:2007
Many companies implement ISO 9001 without using all the available tools. As a result, some companies may not fully optimize their implementation. This issue could be manifested as confusion over terms, misunderstanding about requirements, and perplexity concerning intention.ISO, the International Organization for Standardization, based in Geneva Switzerland issues thousands of standards, but we limit our scope to ISO 9001:2008 and its immediate “family”.This includes ISO 9000:2005 and ISO 9004:20002. ISO 9001 is a general industry standard for quality management, but ISO also issues industry specific standards. Many of these standards, such as ISO 13485 for medical devices, are based on ISO 9001 and can also utilize these available tools.
In addition to the information discussed below, ISO also issues standards related to specific activities that may arises in a quality management system. The following lists these supporting documents.
Automotive ISO/TS 16949:2002Education IWA 2:2007Energy PC 242, ISO 50001Food safety ISO 22000:2005Information security ISO/IEC 27001:2005Health care IWA 1:2005Local government IWA 4:2005Medical devices ISO 13485:2003Petroleum and gas ISO 29001:2003Ship recycling ISO/PAS 30000:2008Supply chain security ISO 28000:2007
Process Approach In ISO 9001 Standards
Process Approach In ISO 9001 Standards
The process approach was introduced into ISO 9001 with the year 2000 version of the standards.Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.1. Identification of processes of the organization1.1. Define the purpose of the organization1.2. Define the policies and objectives of the organization1.3. Determine the processes in the organization1.4. Determine the sequence of the processes1.5. Define process ownership1.6. Define process documentation2. Planning of a process2.1. Define the activities within the process2.2. Define the monitoring and measurement requirements2.3. Define the resources needed
2.4. Verify the process and its activities against its planned objectives3. Implementation and measurement of the process4. Analysis of the process5. Corrective action and improvement of the process ImplementationThis document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.In addition to the guidance documents, ISO maintains a web site with “official interpretations” of ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.Auditing PracticesThe ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS) experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.
The process approach was introduced into ISO 9001 with the year 2000 version of the standards.Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.1. Identification of processes of the organization1.1. Define the purpose of the organization1.2. Define the policies and objectives of the organization1.3. Determine the processes in the organization1.4. Determine the sequence of the processes1.5. Define process ownership1.6. Define process documentation2. Planning of a process2.1. Define the activities within the process2.2. Define the monitoring and measurement requirements2.3. Define the resources needed
2.4. Verify the process and its activities against its planned objectives3. Implementation and measurement of the process4. Analysis of the process5. Corrective action and improvement of the process ImplementationThis document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.In addition to the guidance documents, ISO maintains a web site with “official interpretations” of ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.Auditing PracticesThe ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS) experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.
Why Deploy Six Sigma?
Why Deploy Six Sigma in your organization?
Here are some reasons why we should be using Six Sigma to make process improvements:
a) It is a structured approach – if we follow the process, people will not forget any important steps along the way before they implement the solution.
b) It helps quantify the benefits and thus make it easier to sell the improvements to senior managers in the company.
c) It uses facts & data and the rigor of statistical testing to arrive at the right root cause instead of fixing symptoms or putting band-aids.
d) There is a greater likelihood of the solution being sustainable if we follow the Six Sigma process.
e) Six Sigma focuses of solving the right problems using the project selection matrix.
f) It has proven itself in a large number of deployments. Frankly, there is no better tool out there to make process improvements – especially when the root cause or the solution is not known.
Here are some reasons why we should be using Six Sigma to make process improvements:
a) It is a structured approach – if we follow the process, people will not forget any important steps along the way before they implement the solution.
b) It helps quantify the benefits and thus make it easier to sell the improvements to senior managers in the company.
c) It uses facts & data and the rigor of statistical testing to arrive at the right root cause instead of fixing symptoms or putting band-aids.
d) There is a greater likelihood of the solution being sustainable if we follow the Six Sigma process.
e) Six Sigma focuses of solving the right problems using the project selection matrix.
f) It has proven itself in a large number of deployments. Frankly, there is no better tool out there to make process improvements – especially when the root cause or the solution is not known.
Quality Planning
Whenever the term “product” is used within the ISO 9001 standard, it refers to both tangible goods and intangible services. The ISO 9001 standard is meant to be generic which means that it is suitable for all kinds of organization, whether commercial or otherwise. The purpose of the quality management system model that is being propagated by the standard is the fulfillment of customer requeirements and expectations in order to induce high levels of customer satisfaction. An unsatisfied customer is essentially a customer whose requirements or needs, and expectations of the level of services being granted upon him/her have not been met. We are all customers because we buy products all the time. So we know what it means to be a dissatisfied customer. The common reaction is to never to go back to that seller and look for other alternatives. A successful organization is one which understands what it takes to meet customer requirements in order to satisfy their needs and expectations. A specific process is thus necessary to resolve any customer complaint or dispute. This process should be geared towards satisfying the customer’s needs and expectations. The parameters of this process should be referenced from the terms of the sale and purchase. This is why it is necessary to review the customer’s requirements before committing to the sales contract. It is necessary that the customer understands what he/she is paying for and it is equally necessary for the organization to understand what it is supposed to deliver. When your organization has these processes in place, then the only thing to do next is to continually measure the effectiveness and subsequently take actions to continually improve the whole process.
ISO 9001 Standards Software
ISO 9001 Standards Software
Companies that need quality management systems realize that products like ISO 9001 software are important tools to insure their product safety, consistency and profitability. Using ISO 9001 software can help guarantee that any company can monitor productivity, customer satisfaction and product quality with reports that contain solid information.
This information is now vital to management in order for maximum efficiency in any industry. This is why ISO 9001 software is vital to any sized company. Continuous improvement means continuous profitability. Here are just a few reasons why:
o Companies increase sales because of better performance, quality, and delivery. This propels you ahead of your competition.
o ISO 9001 software helps retain employees and attract more highly qualified employees because they are assured of a controlled and consistent work environment.
o The experience of a more professional workplace boosts employee morale.
o Reduced operating costs dramatically increase your company’s productivity, leading to higher profitability.
o Customer satisfaction and higher profitability expand your market share and demand for your consistently higher product quality.
o When you’re compliant or certified to the appropriate standard, the businesses that work with you know that quality objectives, continuous improvement, and customer satisfaction are your goals.
Many companies require that their suppliers are ISO 9001 compliant; therefore, once you’re certified, your opportunities increase. ISO 9001 software has be utilized and has developed experience of helping manufacturing, service, and distribution organizations to be more efficient and more profitable through continuous improvement programs. We help you to implement the time-tested methods of continuous improvement to measure performance, analyze data, and apply the appropriate process changes. This includes using ISO 9001 software.
ISO 9001 software also offers a suite of modules to enable you to manage the document management and ISO 9001 Compliance Management process. These modules enable complete transparent system measurement with targeted action items ensuring all persons are notified of tasks and carry them out in a prompt and efficient manner. ISO 9001 software provides training in there software and also bring extensive experience in implementing the ISO 9001 software in various environments.
Companies that need quality management systems realize that products like ISO 9001 software are important tools to insure their product safety, consistency and profitability. Using ISO 9001 software can help guarantee that any company can monitor productivity, customer satisfaction and product quality with reports that contain solid information.
This information is now vital to management in order for maximum efficiency in any industry. This is why ISO 9001 software is vital to any sized company. Continuous improvement means continuous profitability. Here are just a few reasons why:
o Companies increase sales because of better performance, quality, and delivery. This propels you ahead of your competition.
o ISO 9001 software helps retain employees and attract more highly qualified employees because they are assured of a controlled and consistent work environment.
o The experience of a more professional workplace boosts employee morale.
o Reduced operating costs dramatically increase your company’s productivity, leading to higher profitability.
o Customer satisfaction and higher profitability expand your market share and demand for your consistently higher product quality.
o When you’re compliant or certified to the appropriate standard, the businesses that work with you know that quality objectives, continuous improvement, and customer satisfaction are your goals.
Many companies require that their suppliers are ISO 9001 compliant; therefore, once you’re certified, your opportunities increase. ISO 9001 software has be utilized and has developed experience of helping manufacturing, service, and distribution organizations to be more efficient and more profitable through continuous improvement programs. We help you to implement the time-tested methods of continuous improvement to measure performance, analyze data, and apply the appropriate process changes. This includes using ISO 9001 software.
ISO 9001 software also offers a suite of modules to enable you to manage the document management and ISO 9001 Compliance Management process. These modules enable complete transparent system measurement with targeted action items ensuring all persons are notified of tasks and carry them out in a prompt and efficient manner. ISO 9001 software provides training in there software and also bring extensive experience in implementing the ISO 9001 software in various environments.
ISO 14001 And The Environment
The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO’s portfolio – but enviroment-related standardization is far from being a new departure for ISO.
In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.
On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total morethan 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.
They also serve in a number of countries as the technical basis for environmental regulations.
ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in
1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.
ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.
This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.
Today, delegations of business and government experts from 55 countries have participate actively within TC 207,
and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.
This national consensus is derived from a process of consultation with interested parties.
From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.
In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.
On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total morethan 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.
They also serve in a number of countries as the technical basis for environmental regulations.
ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in
1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.
ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.
This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.
Today, delegations of business and government experts from 55 countries have participate actively within TC 207,
and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.
This national consensus is derived from a process of consultation with interested parties.
From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.
ISO 9000 and ISO 14000 in plain language
Both “ISO 9000” and “ISO 14000” are actually families of standards which are referred to under these generic titles for convenience. Both families consist of standards and guidelines relating to management systems, and related supporting standards on terminology and specific tools, such as auditing (the process of checking that the management systemconforms to the standard).
ISO 9000 is primarily concerned with “quality management“. In the everyday context, like “beauty”, everyone may have his or her idea of what “quality” is. But, in the ISO 9000 context, the standardized definition of quality refers to all those features of a product (or service) which are required by the customer. “Quality management” means what the organization does to ensure that its products or services satisfy the customer’s quality requirements and comply with any regulationsapplicable to those products or services.
ISO 14000 is primarily concerned with “environmental management”. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.
In addition, both ISO 9000 and ISO 14000 require organizations that implement them to improve their performance continually in, respectively, quality and environmental management.
Both ISO 9000 and ISO 14000 concern the way an organization goes about its work, and not directly the result of this work. In other words, they both concern processes, and not products – at least, not directly. Nevertheless, the way in which the organization manages its processes is obviously going to affect its final product.
In the case of ISO 9000, the efficient and effective management of processes is, for example, going to affect whether or not everything has been done to ensure that the product satisfies the customer’s quality requirements. In the case of ISO 14000, the efficient and effective management of processes is going to affect whether or not everything has been done to ensure a product will have the least harmful impact on the environment, at any stage in its life cycle, either by pollution, or by depleting natural resources.
However, neither ISO 9000 nor ISO 14000 are product standards. The management system standards in these families state requirements for what the organization must do to manage processes influencing quality (ISO 9000) or the processes influencing the impact of the organization’s activities on the environment (ISO 14000). In both cases, the philosophy is that management system requirements are generic. No matter what the organization is or does, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features which are spelled out in the relevant ISO 9000 or ISO 14000 standards.
ISO 9000 is primarily concerned with “quality management“. In the everyday context, like “beauty”, everyone may have his or her idea of what “quality” is. But, in the ISO 9000 context, the standardized definition of quality refers to all those features of a product (or service) which are required by the customer. “Quality management” means what the organization does to ensure that its products or services satisfy the customer’s quality requirements and comply with any regulationsapplicable to those products or services.
ISO 14000 is primarily concerned with “environmental management”. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.
In addition, both ISO 9000 and ISO 14000 require organizations that implement them to improve their performance continually in, respectively, quality and environmental management.
Both ISO 9000 and ISO 14000 concern the way an organization goes about its work, and not directly the result of this work. In other words, they both concern processes, and not products – at least, not directly. Nevertheless, the way in which the organization manages its processes is obviously going to affect its final product.
In the case of ISO 9000, the efficient and effective management of processes is, for example, going to affect whether or not everything has been done to ensure that the product satisfies the customer’s quality requirements. In the case of ISO 14000, the efficient and effective management of processes is going to affect whether or not everything has been done to ensure a product will have the least harmful impact on the environment, at any stage in its life cycle, either by pollution, or by depleting natural resources.
However, neither ISO 9000 nor ISO 14000 are product standards. The management system standards in these families state requirements for what the organization must do to manage processes influencing quality (ISO 9000) or the processes influencing the impact of the organization’s activities on the environment (ISO 14000). In both cases, the philosophy is that management system requirements are generic. No matter what the organization is or does, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features which are spelled out in the relevant ISO 9000 or ISO 14000 standards.
ISO 9001 Standards In General
ISO 9001 Standards In General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by— its business environment, changes in that environment, or risks associated with that environment,— its varying needs,— its particular objectives,— the products it provides,— the processes it employs,— its size and organizational structure.It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying theassociated requirement.This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to theproduct, and the organization’s own requirements.The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by— its business environment, changes in that environment, or risks associated with that environment,— its varying needs,— its particular objectives,— the products it provides,— the processes it employs,— its size and organizational structure.It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying theassociated requirement.This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to theproduct, and the organization’s own requirements.The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.
ISO 9001 – Compatibility with other management systems
ISO 9001 – Compatibility with other management systems
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the qualitymanagement system in meeting customer requirements.ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financialmanagement or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible foran organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the qualitymanagement system in meeting customer requirements.ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financialmanagement or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible foran organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.
Certification In ISO 9001 Standards
Certification In ISO 9001 Standards
Certification involves an independent assessment of your quality system to confirm that it meets the requirements of ISO 9001. You will need to design, document and implement your own quality system. The system will need to cover all the requirements of the ISO 9001 standard. Many certification bodies will not conduct a formal assessment until the system has been operating for at least three months. Your quality system cannot be audited until you have generated documentary evidence to show that you are meeting the standard. To find a certification body with relevant experience in your sector and accreditation from the United Kingdom Accreditation Service (UKAS). Certification by a non-UKAS accredited body is likely to lead to credibility problems with your customers. Arrange a visit from the certification body’s auditors. UKAS prohibits auditors from acting as consultants. They will not tell you how to meet the standard but can offer advice. They will seek objective evidence that you are complying with each of the clauses of the ISO 9001 standard. The auditors will tell you of any shortcomings in your system. If you satisfy the standard, the auditors put your name forward for certification. You will be required to correct these problems within a specified timeframe. You can also be certificated if the auditors only identify a small number of ‘minor’ problems. Once you are certificated, you can display the certification body’s logo, and if the body is UKAS-accredited, the UKAS ‘tick and crown’ symbol (consult UKAS about exceptions to this rule). If the auditors identify more serious ‘major’ problems, you will be required to correct these before certification. These surveillance visits normally take place twice a year at agreed dates. All certification bodies are required to revisit registered companies to ensure they still meet the requirements of the standard. You will be given time to deal with any minor or major problems which are identified before any action is taken to withdraw your certificate.
Certification involves an independent assessment of your quality system to confirm that it meets the requirements of ISO 9001. You will need to design, document and implement your own quality system. The system will need to cover all the requirements of the ISO 9001 standard. Many certification bodies will not conduct a formal assessment until the system has been operating for at least three months. Your quality system cannot be audited until you have generated documentary evidence to show that you are meeting the standard. To find a certification body with relevant experience in your sector and accreditation from the United Kingdom Accreditation Service (UKAS). Certification by a non-UKAS accredited body is likely to lead to credibility problems with your customers. Arrange a visit from the certification body’s auditors. UKAS prohibits auditors from acting as consultants. They will not tell you how to meet the standard but can offer advice. They will seek objective evidence that you are complying with each of the clauses of the ISO 9001 standard. The auditors will tell you of any shortcomings in your system. If you satisfy the standard, the auditors put your name forward for certification. You will be required to correct these problems within a specified timeframe. You can also be certificated if the auditors only identify a small number of ‘minor’ problems. Once you are certificated, you can display the certification body’s logo, and if the body is UKAS-accredited, the UKAS ‘tick and crown’ symbol (consult UKAS about exceptions to this rule). If the auditors identify more serious ‘major’ problems, you will be required to correct these before certification. These surveillance visits normally take place twice a year at agreed dates. All certification bodies are required to revisit registered companies to ensure they still meet the requirements of the standard. You will be given time to deal with any minor or major problems which are identified before any action is taken to withdraw your certificate.
Costs and resources Of ISO 9001 Standards
Costs and resources Of ISO 9001 Standards
The largest cost of ISO 9001 is the involvement of company
employees. The ‘ownership’ created by involving employees in designing the quality system maximises the chances of them accepting it. Reducing this cost by minimising employee involvement is a false economy. The next largest cost will be for designing and developing the system. This needs to be led by someone with experience in this particular field. You may have someone within your own organisation who has carried out this role, perhaps with a former employer. Your Business Link may offer free or subsidised advice and training, and will be able to provide names of approved consultants. Grants for work in this area tend to be directed through Business Links. Different areas have different grants, which depend on local conditions. A typical grant may cover up to 50 per cent of the cost of an approved consultant. Certification fees are around £800 for the smallest companies. Overall costs depend upon company size and the number of locations involved. Ask certification bodies for quotes for initial audits and surveillance visits. Many will give an all-inclusive price, including surveillance visits for three years. Typically, special rates will depend on how long the assessment is likely to take and what the company’s turnover is. Ask your certification body if it offers special rates for small companies. The standard requires that companies have trained internal auditors to conduct audits on the system. An internal audit can provide an effective means of monitoring the system and identifying areas for improvement. For further details, contact the International Register of Certificated Auditors.
The largest cost of ISO 9001 is the involvement of company
employees. The ‘ownership’ created by involving employees in designing the quality system maximises the chances of them accepting it. Reducing this cost by minimising employee involvement is a false economy. The next largest cost will be for designing and developing the system. This needs to be led by someone with experience in this particular field. You may have someone within your own organisation who has carried out this role, perhaps with a former employer. Your Business Link may offer free or subsidised advice and training, and will be able to provide names of approved consultants. Grants for work in this area tend to be directed through Business Links. Different areas have different grants, which depend on local conditions. A typical grant may cover up to 50 per cent of the cost of an approved consultant. Certification fees are around £800 for the smallest companies. Overall costs depend upon company size and the number of locations involved. Ask certification bodies for quotes for initial audits and surveillance visits. Many will give an all-inclusive price, including surveillance visits for three years. Typically, special rates will depend on how long the assessment is likely to take and what the company’s turnover is. Ask your certification body if it offers special rates for small companies. The standard requires that companies have trained internal auditors to conduct audits on the system. An internal audit can provide an effective means of monitoring the system and identifying areas for improvement. For further details, contact the International Register of Certificated Auditors.
ISO 9000 family of standards and SMEs
ISO 9000 family of standards and SMEs
The ISO 9000 quality management system is generic in nature and applicable to all companies, regardless of the type and size of the business, including small and medium enterprises (SMEs), and they are applicable to all categories of products, whether hardware, software, processed materials or services. ISO 9001:2008 specifies what is required to be done by an organization but does not indicate how it should be done, thus giving the enterprise a lot of flexibility to run its business.
It is simple to use, clear in language and easily understandable. The new standard is also appropriate for small companies, as it does not demand the type of paper bureaucracy needed for the implementation of the 1994 version. Only six documented procedures are now required and need for other procedures/documents can be decided by the company. Companies will, however, be required to provide objective evidence that the QMS has been effectively implemented. A small company may find it appropriate to include the description of its entire QMS within a single Quality Manual, including all the documented procedures required by the standard.
The process-based approach given in the new standard will tend to ensure that systems are documented and implemented in a manner that suits a SME’s own way of doing business. This approach makes it easier for SMEs to implement, instead of just taking over an artificial structure of QMS imposed from outside. It will also be easier for SMEs managed by their owners to demonstrate “top management commitment” towards QMS. Furthermore, in a SME, it is easier to ensure effective internal communication, better utilization of resources, people clearly understanding their roles and responsibilities, etc.
The new standard has included a provision for deciding on the applicability of
certain product realization processes included in section 7 of the standard. For example, if the SME has no responsibility for the design and development of the product it provides, the SME may say so, giving the reasoning behind it, in the Quality Manual; the certification body, being satisfied that this corresponds, would then award it certification to ISO 9001:2008. Similarly, other product realization processes such as purchasing, product identification and traceability, control of measuring devices may also be excluded if these are not applicable for the type of products or services being provided by the company.
It is also possible that SMEs may not have adequate in-house expertise or there may be other constraints to perform all processes on their own. In such cases, the new standard also permits the outsourcing of any of the QMS processes, providing the company has control over such processes. The nature of this control will depend on the nature of the outsourced or subcontracted processes and the risk involved. For example, the design and development process may be subcontracted to an expert or a specialized agency, inspection/verification of goods purchased may be subcontracted to an inspection agency, internal audit of QMS can be outsourced, etc. However, overall responsibility for ensuring control on all outsourced processes as per requirements of the standard would remain with the company’s management.
The ISO 9000 quality management system is generic in nature and applicable to all companies, regardless of the type and size of the business, including small and medium enterprises (SMEs), and they are applicable to all categories of products, whether hardware, software, processed materials or services. ISO 9001:2008 specifies what is required to be done by an organization but does not indicate how it should be done, thus giving the enterprise a lot of flexibility to run its business.
It is simple to use, clear in language and easily understandable. The new standard is also appropriate for small companies, as it does not demand the type of paper bureaucracy needed for the implementation of the 1994 version. Only six documented procedures are now required and need for other procedures/documents can be decided by the company. Companies will, however, be required to provide objective evidence that the QMS has been effectively implemented. A small company may find it appropriate to include the description of its entire QMS within a single Quality Manual, including all the documented procedures required by the standard.
The process-based approach given in the new standard will tend to ensure that systems are documented and implemented in a manner that suits a SME’s own way of doing business. This approach makes it easier for SMEs to implement, instead of just taking over an artificial structure of QMS imposed from outside. It will also be easier for SMEs managed by their owners to demonstrate “top management commitment” towards QMS. Furthermore, in a SME, it is easier to ensure effective internal communication, better utilization of resources, people clearly understanding their roles and responsibilities, etc.
The new standard has included a provision for deciding on the applicability of
certain product realization processes included in section 7 of the standard. For example, if the SME has no responsibility for the design and development of the product it provides, the SME may say so, giving the reasoning behind it, in the Quality Manual; the certification body, being satisfied that this corresponds, would then award it certification to ISO 9001:2008. Similarly, other product realization processes such as purchasing, product identification and traceability, control of measuring devices may also be excluded if these are not applicable for the type of products or services being provided by the company.
It is also possible that SMEs may not have adequate in-house expertise or there may be other constraints to perform all processes on their own. In such cases, the new standard also permits the outsourcing of any of the QMS processes, providing the company has control over such processes. The nature of this control will depend on the nature of the outsourced or subcontracted processes and the risk involved. For example, the design and development process may be subcontracted to an expert or a specialized agency, inspection/verification of goods purchased may be subcontracted to an inspection agency, internal audit of QMS can be outsourced, etc. However, overall responsibility for ensuring control on all outsourced processes as per requirements of the standard would remain with the company’s management.
Management Principles Of ISO 9001 Standards
Management Principles Of ISO 9001 Standards
ISO 9000 is based on eight management principles:
• Customer focus, resulting in meeting customer requirements and striving to exceed them;
• Leadership, aiming to create an internal environment in which people are fully involved;
• Involvement of people who are the essence of an organization;
• Process approach, resulting in improved efficiency to obtain desired results;
• System approach to management, leading to improved effectiveness and efficiency through identification, understanding and management of interrelated processes;
• Continual improvement, which becomes a permanent objective of the organization;
• Factual approach to decision-making, based on the analysis of data and information; and
• Mutually beneficial supplier relationships, based on an understanding of their interdependence.
ISO 9000 encourages the adoption of the process approach to manage an organization. There are five main areas considered for the revised process model in ISO 9000:
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement.
ISO 9000 is based on eight management principles:
• Customer focus, resulting in meeting customer requirements and striving to exceed them;
• Leadership, aiming to create an internal environment in which people are fully involved;
• Involvement of people who are the essence of an organization;
• Process approach, resulting in improved efficiency to obtain desired results;
• System approach to management, leading to improved effectiveness and efficiency through identification, understanding and management of interrelated processes;
• Continual improvement, which becomes a permanent objective of the organization;
• Factual approach to decision-making, based on the analysis of data and information; and
• Mutually beneficial supplier relationships, based on an understanding of their interdependence.
ISO 9000 encourages the adoption of the process approach to manage an organization. There are five main areas considered for the revised process model in ISO 9000:
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement.
Costs Of Setting Up A Quality Management System
Costs Of Setting Up A Quality Management System
Common implementation costs that companies incur can be broken down into direct and indirect costs.
The direct costs include, inter alia, the following:
• hiring consultants or external trainers, if required;
• sending personnel for external training;
• acquiring relevant national and international standards of the ISO 9000 family and other related books and publications; and
• acquiring additional equipment, instruments and other resources as identified by the company.
The indirect costs include, inter alia, the following:
• time spent by the management and other staff in developing the system;
• reorganization of the processes, including improvements in the house-keeping, if required;
• external calibration charges for equipment to ensure national and/or international measurement traceability;
• organizing in-house training;
• time spent by internal auditors for periodic internal audits;
• corrective actions, including revision of manuals and procedures, if required; and
• expenditure on word-processing, stationery and other consumables required for the preparation of manuals and documenting procedures, etc.
Some factors can help to lower the above costs. They include:
• having people in the company already conversant with QMS requirements;
• having documented system-related activities such as work instructions, quality plans, procedures, etc. already in place;
• using consultants only for specific activities like gap analysis, training of
auditors, pre-assessment audits, etc., and having in-house staff oversee the remaining activities.
On the other hand, there are factors that can mean higher implementation costs for the company. For example, if your company carries out activities at different locations, or if your company is involved in product design and development, this may increase costs.
Common implementation costs that companies incur can be broken down into direct and indirect costs.
The direct costs include, inter alia, the following:
• hiring consultants or external trainers, if required;
• sending personnel for external training;
• acquiring relevant national and international standards of the ISO 9000 family and other related books and publications; and
• acquiring additional equipment, instruments and other resources as identified by the company.
The indirect costs include, inter alia, the following:
• time spent by the management and other staff in developing the system;
• reorganization of the processes, including improvements in the house-keeping, if required;
• external calibration charges for equipment to ensure national and/or international measurement traceability;
• organizing in-house training;
• time spent by internal auditors for periodic internal audits;
• corrective actions, including revision of manuals and procedures, if required; and
• expenditure on word-processing, stationery and other consumables required for the preparation of manuals and documenting procedures, etc.
Some factors can help to lower the above costs. They include:
• having people in the company already conversant with QMS requirements;
• having documented system-related activities such as work instructions, quality plans, procedures, etc. already in place;
• using consultants only for specific activities like gap analysis, training of
auditors, pre-assessment audits, etc., and having in-house staff oversee the remaining activities.
On the other hand, there are factors that can mean higher implementation costs for the company. For example, if your company carries out activities at different locations, or if your company is involved in product design and development, this may increase costs.
Benefits Of Obtaining ISO 9000 Certification
Benefits Of Obtaining ISO 9000 Certification
Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-Ã -vis the outside world.
Internal benefits to the company include:
• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;
• more confidence that the company’s products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by customers.
Refer http://www.iso9001-standard.us for more information.
Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-Ã -vis the outside world.
Internal benefits to the company include:
• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;
• more confidence that the company’s products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by customers.
Refer http://www.iso9001-standard.us for more information.
Implementing A Quality Management System
Implementing A Quality Management System
An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:
1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.
At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
2. Obtain information about the ISO 9000 family
The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.
Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;
3. Appoint a consultant, if necessary
If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.
4. Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.
5. Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.
6. Product realization processes
Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.
The processes covered by this clause include:
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of measuring and monitoring devices
Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
7. Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
8. Planning a time frame
Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and
7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.
9. Draft a Quality Manual
In your Quality Manual;
• Include how the QMS applies to the products, processes, locations and departments of the organization;
• Exclude any requirement with justification for doing so as decided in step 6
above;
• Refer to or include documented procedures for QMS;
• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and
• Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.
The effective date of implementation should also be decided.
10. Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.
11. Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.
12. Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.
An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:
1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.
At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
2. Obtain information about the ISO 9000 family
The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.
Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;
3. Appoint a consultant, if necessary
If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.
4. Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.
5. Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.
6. Product realization processes
Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.
The processes covered by this clause include:
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of measuring and monitoring devices
Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
7. Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
8. Planning a time frame
Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and
7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.
9. Draft a Quality Manual
In your Quality Manual;
• Include how the QMS applies to the products, processes, locations and departments of the organization;
• Exclude any requirement with justification for doing so as decided in step 6
above;
• Refer to or include documented procedures for QMS;
• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and
• Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.
The effective date of implementation should also be decided.
10. Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.
11. Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.
12. Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.
ISO 9001 Standards – Management Review
ISO 9001 Standards – Management Review
Review the quality management system at planned intervals to:- Assess possible opportunities for improvementEnsure a suitable, adequate, and effective system
- Evaluate the need for any changes to the system
- Consider the need for changes to the quality policy and objectives
Maintain records of the management reviews.
Inputs for management review must include information on:
- Results of audits
- Customer feedback
- Process performance and product conformity
- Status of preventive and corrective actions
- Follow-up actions from earlier reviews
- Changes that could affect the quality system
- Recommendations for improvement
Outputs from the management review must include any decisions and actions related to:
- Improvement of the effectiveness of the quality management system and its processes
- Improvement of product related to customer requirements
- Resource needs
Review the quality management system at planned intervals to:- Assess possible opportunities for improvementEnsure a suitable, adequate, and effective system
- Evaluate the need for any changes to the system
- Consider the need for changes to the quality policy and objectives
Maintain records of the management reviews.
Inputs for management review must include information on:
- Results of audits
- Customer feedback
- Process performance and product conformity
- Status of preventive and corrective actions
- Follow-up actions from earlier reviews
- Changes that could affect the quality system
- Recommendations for improvement
Outputs from the management review must include any decisions and actions related to:
- Improvement of the effectiveness of the quality management system and its processes
- Improvement of product related to customer requirements
- Resource needs
ISO 9001 Standards – Design and Development
ISO 9001 Standards - Design and Development
Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions
- Stages of design and development
- Appropriate review, verification, and validation activities for each stage
- Responsibility and authority for design and development
The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.
NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Determine product requirement inputs and maintain records. The inputs must include:
- Functional and performance requirements
- Applicable statutory and regulatory requirements
- Applicable information derived from similar designs
- Requirements essential for design and development
Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:
- Meet design and development input requirements
- Provide information for purchasing, production, and service
- Contain or reference product acceptance criteria
- Define essential characteristics for safe and proper use
- Be approved before their release
Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:
- Evaluate the ability of the results to meet requirements
- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.
Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions
- Stages of design and development
- Appropriate review, verification, and validation activities for each stage
- Responsibility and authority for design and development
The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.
NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Determine product requirement inputs and maintain records. The inputs must include:
- Functional and performance requirements
- Applicable statutory and regulatory requirements
- Applicable information derived from similar designs
- Requirements essential for design and development
Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:
- Meet design and development input requirements
- Provide information for purchasing, production, and service
- Contain or reference product acceptance criteria
- Define essential characteristics for safe and proper use
- Be approved before their release
Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:
- Evaluate the ability of the results to meet requirements
- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.
ISO 9001 Standards – Control of Measuring and Monitoring Equipment
ISO 9001 Standards - Control of Measuring and Monitoring Equipment
Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
Where necessary to ensure valid results:
- Calibrate and/or verify the measuring equipment at specified intervals or prior to use
- Calibrate the equipment to national or international standards (or record other basis)
- Adjust or re-adjust as necessary
- Identify the measuring equipment in order to determine its calibration status
- Safeguard them from improper adjustments
- Protect them from damage and deterioration
Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.
Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).
NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
For More Information Please Visit http://www.iso9001-standard.us
Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
Where necessary to ensure valid results:
- Calibrate and/or verify the measuring equipment at specified intervals or prior to use
- Calibrate the equipment to national or international standards (or record other basis)
- Adjust or re-adjust as necessary
- Identify the measuring equipment in order to determine its calibration status
- Safeguard them from improper adjustments
- Protect them from damage and deterioration
Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.
Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).
NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
For More Information Please Visit http://www.iso9001-standard.us
ISO 14001:2004 Standards Contents
ISO 14001:2004 Standards
ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.
ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.
ISO 9001 Standards New Blogs
Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/
ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System
ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System (QMS)
- An Romania Perspective
The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.
Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.
The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.
Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.
Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.
ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.
The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.
Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.
ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.
The documentation of QMS involves:
1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)
2. Management Responsibility
3. Resource Management
4. Product Realisation
5. Measurements, Analysis and Improvement
A well managed quality system will have impact on:
1. customer loyalty and repeat business
2. market share
3. operational efficiencies
4. flexibility and ability to respond to market opportunities
5. effective and efficient use of resources
6. cost reductions
7. competitive advantages
- An Romania Perspective
The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.
Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.
The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.
Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.
Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.
ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.
The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.
Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.
ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.
The documentation of QMS involves:
1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)
2. Management Responsibility
3. Resource Management
4. Product Realisation
5. Measurements, Analysis and Improvement
A well managed quality system will have impact on:
1. customer loyalty and repeat business
2. market share
3. operational efficiencies
4. flexibility and ability to respond to market opportunities
5. effective and efficient use of resources
6. cost reductions
7. competitive advantages
ISO 9001 Standards – Documented Procedures
ISO 9001 Standards – Documented Procedures
The standard requires the management system documentation to include documented procedures required by ISO 9001 Standards.
ISO 9000 defines a procedure as a specified way to carry out an activity or a process. This definition is ambiguous because an activity is on a different scale than a process. Process outputs are dependent upon many factors of which activities are but one. An activity is the smallest unit of work. Several activities accomplish a task and several tasks reflect the stages in a process but there is more to a process than a series of tasks. This definition also esults in a belief that procedures are documented processes but this too is inaccurate. Procedures tell us how to proceed don‘t need to produce any others. The specific procedures required are:
(a) A documented procedure for document control
(b) A documented procedure for the control of records
(c) A documented procedure for conducting audits
(d) A documented procedure for nonconformity control
(e) A documented procedure for corrective action
(f) A documented procedure for preventive action
These areas all have something in common. They are what the authors of the early drafts of ISO 9000 :2008 referred to as system procedures ? they apply to the whole system and are not product, process or customer specific although it is not uncommon for customers to specify requirements that would impact these areas. Why procedures for these aspects are required and not for other aspects of the management system is unclear but it seems that the authors of ISO 9000 felt these were not processes ? a conclusion I find difficult to justify.
They are certainly not business processes but could be work processes. However, there is another message that this requirement conveys. It is that procedures are not required for each clause of the standard. Previously, countless organizations produced a manual of 20 procedures to match the 20 elements of ISO 9001. Some limited their procedures to the 26 procedures cited by the standard and others produced as many as were necessary to respond to the requirements.
Document control is a work process or a number of work processes because the inputs pass through a number of stages each adding value to result in the achievement of defined objectives. These are the acquisition, approval, publication, distribution, storage, maintenance, improvement, and disposal stages. These are not tasks but processes that achieve defined objectives and involve both physical, financial and human resources. Within these processes are tasks, each of which may require documented procedures as they are initiated.
Control of records is also a work process similar to document control. There are the preparation, storage, access, maintenance and disposal stages. This is not one uninterrupted flow but a life cycle. There is not one task but several performed at different times for different reasons.
Auditing is certainly a process with a defined objective. Without the provision of competent personnel and a suitable environment, audits will not achieve their objectives no matter how many times the procedure is implemented.
Nonconformity control like records control is a work process for the same reasons. The sequence of tasks is not in the form of an uninterrupted sequence. The sequence of stages may be identification, documentation, segregation, review, remedial action and disposal but this is not a continuous sequence. There are breaks and different procedures may apply at each stage depending on what it is that is nonconforming.
There is little merit in having one corrective action procedure when the source of problems that require corrective action is so varied. One Corrective Action Form might be appropriate but its application will be so varied that it is questionable whether one size fits all. Presenting top management with a nonconformity report because it has been detected that the organization charts are not promptly updated following a change, will not motivate them into action. Corrective action forms part of every process rather than being a separate process. It is unreasonable to force all actions aimed at preventing the recurrence of problems through one process. Many problems are prevented from recurring not by following a procedure, but by the designer, the producer, supplier, manager remembering they had a problem last time and doing it differently the next ? i.e. they learn from their mistakes. No forms filled in, no procedures followed ? just people using their initiative ? this is why corrective action is part of every process operation.
Preventive action remains one of the most misunderstood requirements of ISO 9001 because it is mistaken for corrective action but more on this. There is even less justification for one preventive action procedure because the source of potential problems is so varied. Preventive actions are taken in design, in planning, in training and in maintenance under the name of FMEA, Reliability Prediction, Quality Planning, Production Planning, Logistic Planning, Staff Development, Equipment Maintenance ? preventive actions are built into these processes and similar to corrective action are part of every process design.
The standard requires the management system documentation to include documented procedures required by ISO 9001 Standards.
ISO 9000 defines a procedure as a specified way to carry out an activity or a process. This definition is ambiguous because an activity is on a different scale than a process. Process outputs are dependent upon many factors of which activities are but one. An activity is the smallest unit of work. Several activities accomplish a task and several tasks reflect the stages in a process but there is more to a process than a series of tasks. This definition also esults in a belief that procedures are documented processes but this too is inaccurate. Procedures tell us how to proceed don‘t need to produce any others. The specific procedures required are:
(a) A documented procedure for document control
(b) A documented procedure for the control of records
(c) A documented procedure for conducting audits
(d) A documented procedure for nonconformity control
(e) A documented procedure for corrective action
(f) A documented procedure for preventive action
These areas all have something in common. They are what the authors of the early drafts of ISO 9000 :2008 referred to as system procedures ? they apply to the whole system and are not product, process or customer specific although it is not uncommon for customers to specify requirements that would impact these areas. Why procedures for these aspects are required and not for other aspects of the management system is unclear but it seems that the authors of ISO 9000 felt these were not processes ? a conclusion I find difficult to justify.
They are certainly not business processes but could be work processes. However, there is another message that this requirement conveys. It is that procedures are not required for each clause of the standard. Previously, countless organizations produced a manual of 20 procedures to match the 20 elements of ISO 9001. Some limited their procedures to the 26 procedures cited by the standard and others produced as many as were necessary to respond to the requirements.
Document control is a work process or a number of work processes because the inputs pass through a number of stages each adding value to result in the achievement of defined objectives. These are the acquisition, approval, publication, distribution, storage, maintenance, improvement, and disposal stages. These are not tasks but processes that achieve defined objectives and involve both physical, financial and human resources. Within these processes are tasks, each of which may require documented procedures as they are initiated.
Control of records is also a work process similar to document control. There are the preparation, storage, access, maintenance and disposal stages. This is not one uninterrupted flow but a life cycle. There is not one task but several performed at different times for different reasons.
Auditing is certainly a process with a defined objective. Without the provision of competent personnel and a suitable environment, audits will not achieve their objectives no matter how many times the procedure is implemented.
Nonconformity control like records control is a work process for the same reasons. The sequence of tasks is not in the form of an uninterrupted sequence. The sequence of stages may be identification, documentation, segregation, review, remedial action and disposal but this is not a continuous sequence. There are breaks and different procedures may apply at each stage depending on what it is that is nonconforming.
There is little merit in having one corrective action procedure when the source of problems that require corrective action is so varied. One Corrective Action Form might be appropriate but its application will be so varied that it is questionable whether one size fits all. Presenting top management with a nonconformity report because it has been detected that the organization charts are not promptly updated following a change, will not motivate them into action. Corrective action forms part of every process rather than being a separate process. It is unreasonable to force all actions aimed at preventing the recurrence of problems through one process. Many problems are prevented from recurring not by following a procedure, but by the designer, the producer, supplier, manager remembering they had a problem last time and doing it differently the next ? i.e. they learn from their mistakes. No forms filled in, no procedures followed ? just people using their initiative ? this is why corrective action is part of every process operation.
Preventive action remains one of the most misunderstood requirements of ISO 9001 because it is mistaken for corrective action but more on this. There is even less justification for one preventive action procedure because the source of potential problems is so varied. Preventive actions are taken in design, in planning, in training and in maintenance under the name of FMEA, Reliability Prediction, Quality Planning, Production Planning, Logistic Planning, Staff Development, Equipment Maintenance ? preventive actions are built into these processes and similar to corrective action are part of every process design.
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