Thursday, October 8, 2009

Continual improvement in the quality management system

Continual Improvement In The Quality Management System
The ISO 9001 standard requires the organization to continually improve the effectiveness of the quality management system in accordance with the requirements of ISO 9001 and to implement action necessary to achieve planned results and continual improvement of the identified processes.
ISO 9000 defines continual improvement as a recurring activity to increase the ability to fulfil requirements. As the organization’s objectives are its requirements, continually improving the effectiveness of the quality management system means continually increasing the ability of the organization to fulfil its objectives.
If the performance of a process parameter is currently meeting the standard that has been established, there are several improvement actions you can take:
Raise the standard e.g. if the norm for the sales ratio of orders won to all orders bid is 60%, an improvement programme could be developed for raising the standard to 75% or higher
Increase efficiency e.g. if the time to process an order is within limits, identify and eliminate wasted resources
Increase effectiveness e.g. if you bid against all customer requests, by only bidding for those you know you can win you improve your hit rate
You can call all these actions improvement actions because they clearly improve performance. However, we need to distinguish between being better at what we do now and doing new things. Some may argue that improving efficiency is being better at what we do now, and so it is – but if in order to improve efficiency we have to be innovative we are truly reaching new standards. Forty years ago, supervisors in industry would cut an eraser in half in the name of efficiency rather than hand out two erasers. Clearly this was a lack of trust disguised as efficiency improvement and it had quite the opposite effect. In fact they were not only increasing waste but also creating a hostile environment.
Each of the improvement actions is dealt with later in the book and the subject of continual improvement addressed again under Quality planning.
There are several steps to undertaking continual improvement:
1. Determine current performance
2 Establish the need for change
3 Obtain commitment and define the improvement objectives
4 Organize diagnostic resources
5 Carry out research and analysis to discover the cause of current performance
6 Define and test solutions that will accomplish the improvement objectives
7 Product improvement plans which specify how and by whom the changes will be implemented
8 Identify and overcome any resistance to change
9 Implement the change
10 Put in place controls to hold new levels of performance and repeat step one
For more information, please visit http://www.iso9001-standard.us

Preparing ISO 9001 Quality Manual

Preparing ISO 9001 Quality Manual
The standard requires a quality manual to be established and maintained that includes the scope of the quality management system, the documented procedures or reference to them and a description of the sequence and interaction of processes included in the quality management system.
ISO 9001 defines a quality manual as a document specifying the quality management system of an organization. It is therefore not intended that the quality manual be a response to the requirements of ISO 9001. As the top-level document describing the management system it is a system description describing how the organization is managed.
Countless quality manuals produced to satisfy ISO 9001:2008, were no more than 20 sections that paraphrased the requirements of the standard. Such documentation adds no value. They are of no use to managers, staff or auditors. Often thought to be useful to customers, organizations would gain no more confidence from customers than would be obtained from their registration certificate.
A description of the management system is necessary as a means of showing how all the processes are interconnected and how they collectively deliver the business outputs. It has several uses as :
1. a means to communicate the vision, values, mission, policies and objectives of the organization
2. a means of showing how the system has been designed
3. a means of showing linkages between processes
4. a means of showing who does what an aid to training new people
5. a tool in the analysis of potential improvements
6. a means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes to achieve them, the manual provides a convenient vehicle for containing such information. If left as separate pieces of information, it may be more difficult to see the linkages.
The requirement provides the framework for the quality manual. Its content may therefore include the following:
1 Introduction
(a) Purpose (of the manual)
(b) Scope (of the manual)
(c) Applicability (of the manual)
(d) Definitions (of terms used in the manual)
2 Business overview
(a) Nature of the business/organization – its scope of activity, its products and services
(b) The organization’s interested parties (customers, employees, regulators, shareholders, suppliers, owners etc.)
(c) The context diagram showing the organization relative to its external environment
(d) Vision, values
(e) Mission
3 Organization
(a) Function descriptions
(b) Organization chart
(c) Locations with scope of activity
4 Business processes
(a) The system model showing the key business processes and how they are interconnected
(b) System performance indicators and method of measurement
(c) Business planning process description
(d) Resource management process description
(e) Marketing process description
(f) Product/service generation processes description
(g) Sales process description
(h) Order fulfilment process description
5 Function matrix (Relationship of functions to processes)
6 Location matrix (Relationship of locations to processes)
7 Requirement deployment matrices
(a) ISO 9001 compliance matrix
(b) ISO 14001 compliance matrix
(c) Regulation compliance matrices (FDA, Environment, Health, Safety, CAA etc.)
8 Approvals (List of current product, process and system approvals)
The process descriptions can be contained in separate documents and should cover the topics identified previously (see Documents that ensure effective planning, operation and control of processes ).
As the quality manual contains a description of the management system a more apt title would be a Management System Manual (MSM) or maybe a title reflecting its purpose might be Management System Description (MSD).
In addition a much smaller document could be produced that does respond to the requirements of ISO 9001, ISO 14001, and the regulations of regulatory authorities. Each document would be an exposition produced purely to map your management system onto these external requirements to demonstrate how your system meets these requirements. When a new requirement comes along, you can produce a new exposition rather than attempt to change your system to suit all parties. A model of such relationships is illustrated in Figure 4.10. The process descriptions that emerge from the Management System Manual describe the core business processes and are addressed in Chapter 4 under the heading of Documents that ensure effective operation and control of processes.

Scope Of The Quality Management System

Scope Of The Quality Management System
The ISO 9001 standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion. The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.
Under ISO 9001:2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because it operated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the quality management system.
It is sensible to describe the scope of the quality management system so as to ensure effective communication. The scope of the quality management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor. Why you need to justify specific exclusions is uncertain because it is more practical to justify inclusions.
The scope of the quality management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.
It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’.
It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable.
For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.

ISO 9001 Quality Policy

ISO 9001 Quality Policy
The standard requires the quality policy to be appropriate to the purpose of the organization.
The purpose of an organization is quite simply the reason for its existence and as Peter Drucker so eloquently put it there is only one valid definition of business purpose: to create a customer”(Drucker, Peter F., 1977)2 . In ensuring that the quality policy is appropriate to the purpose of the organization, it must be appropriate to the customers the organization desires to create. It is therefore necessary to establish who the customers are, where the customers are, what they buy or wish to receive and what these customers regard as value. As stated above, the quality policy is the corporate policy and such policies exist to channel actions and decisions along a path that will fulfil the organization’s purpose and mission. A goal of the organization may be the attainment of ISO 9001 certification and thus a quality policy of meeting the requirements of ISO 9001 would be consistent with such a goal, but goals are not the same as purpose as indicated in the box to the right. Clearly no organization would have ISO 9001 certification as its purpose because certification is not a reason for existence – an objective maybe but not a purpose.
Policies expressed as short catchy phrases such as “to be the best” really do not channel actions and decisions. They become the focus of ridicule when the organization’s fortunes change. There has to be a clear link from mission to quality policy.
Policies are not expressed as vague statements or emphatic statements using the words may, should or shall, but clear intentions by use of the words ‘we will’
– thus expressing a commitment or by the words ‘we are, we do, we don’t, we have’ expressing shared beliefs. Very short statements tend to become slogans which people chant but rarely understand the impact on what they do. Their virtue is that they rarely become outdated. Long statements confuse people because they contain too much for them to remember. Their virtue is that they not only define what the company stands for but how it will keep its promises.
In the ISO 9001 definition of quality policy it is suggested that the eight quality management principles be used as a basis for establishing the quality policy.
One of these principles is the Customer Focus principle. By including in the quality policy the intention to identify and satisfy the needs and expectations of customers and other interested parties and the associated strategy by which this will be achieved, this requirement would be fulfilled. The inclusion of the strategy is important because the policy should guide action and decision. Omitting the strategy may not ensure uniformity of approach and direction.
The standard requires that the quality policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system.
A commitment to comply with requirements means that the organization should undertake to meet the requirements of all interested parties. This means meeting the requirements of customer, suppliers, employees, investors, owners and society. Customer requirements are those either specified or implied by customers or determined by the organization and these are dealt with in more detail under clauses 5.2 and 7.2.1. The requirements of employees are those covered by legislation such as access, space, environmental conditions, equal opportunities and maternity leave but also the legislation appropriate to minority groups such as the disabled and any agreements made with unions or other representative bodies. Investors have rights also and these will be addressed in the investment agreements. The requirements of society are those obligations resulting from laws, statutes, regulations etc.
An organization accepts such obligations when it is incorporated as a legal entity, when it accepts orders from customers, when it recruits employees, when it chooses to trade in regulated markets and when it chooses to use or process materials that impact the environment.
The effectiveness of the management system is judged by the extent to which it fulfils its purpose. Therefore improving effectiveness means improving the capability of the management system. Changes to the management system that improve its capability i.e its ability to deliver outputs that satisfy all the interested parties, are a certain types of change and not all management system changes will accomplish this. This requirement therefore requires top management to pursue changes that bring about an improvement in performance.

ISO 14001 ENVIRONMENTAL POLICY

ISO 14001 ENVIRONMENTAL POLICY
The intent of an environmental policy is to state the organization’s commitment to continuous improvement in environmental performance. A strong, clear environmental policy can serve as both a starting point for developing the EMS and a reference point for maintaining continuous improvement.The policy should be evaluated regularly and modified, as necessary, to reflect changing environmental priorities.The policy should function in two ways: (1) within the company, the policy should focus attention on environmental issues associated with company activities, products, and services; and (2) outside the company, the policy is a public commitment to addressing environmental issues and continuously improving environmental performance.The environmental policy must address:• Commitment to compliance with relevant environmental legislation andregulations• Pollution prevention• Continuous improvement
Tips for Developing an Environmental Policy:1. Develop a policy that reflects perspectives of various employees within the company (for example, line worker, owner, wastewater treatment operator, quality inspector, compliance/legal manager, production manager).2. Display the policy statement in view of all employees; the policy should be available to the public and customers if requested and be printed in languages other than English, as appropriate.3. Include top management signatures on the policy to demonstrate understanding and commitment.Purpose This procedure is used to develop and write the company’s environmental policy.
Step 1 The environmental manager will form a policy development team responsible for developing and writing the environmental policy. The policy will address, at a minimum, compliance, pollution prevention, and continuous improvement.
Step 2 The policy development team will review other relevant documents to ensure consistency with other company policies and guide the content and phrasing of the policy. Example documents include the company mission statement and the example environmental policies included in this EMS element.
Step 3 The policy will be displayed in view of all employees and introduced to new employees; the policy will be available in languages other than English, as appropriate, and to the public (on request) and customers (as appropriate).Step 4 The environmental manager will review the environmental policy at least annually, and update it if needed.
Responsible Person: _____________________________________Signature and Date: ______________________________________
Environmental Policy Example 1
It is the policy of COMPANY NAME to conduct its operations in a manner that is environmentally responsible and befitting a good corporate neighbor and citizen.In accordance with this policy, COMPANY NAME complies with all environmental laws and manages all phases of its business in a manner that minimizes the impact of its operations on the environment.To further this policy, COMPANY NAME shall:1. Include environmental requirements in planning and design activities2. Comply with applicable environmental laws and regulations3. Eliminate, or reduce to the maximum practical extent, the release of contaminants into the environment, first through pollution prevention (material substitution and source reduction), then recycling, and finally through treatment and control technologies4. Effectively communicate with company employees, suppliers, regulators, and customers, as well as the surrounding community, regarding the environmental impact of company operations5. Periodically review and demonstrate continuous improvement in the company’s environmental management system
SIGNATURE___________________
Responsible Person______________________
Environmental Policy Sample 2
Effective Date
ENVIRONMENTAL POLICY
_________________________ IS COMMITTED TO IMPROVE THE HEALTH, SAFETY AND ENVIRONMENT FOR OUR EMPLOYEES, NEIGHBORS, AND FAMILIES.
WE WILL MEET AND OR EXCEED LAWFUL COMPLIANCE THROUGH POLLUTION PREVENTION PRACTICES AND CONTINUOUS IMPROVEMENT.
TO IMPLEMENT THIS POLICY WE WILL CREATE AN ENVIRONMENTAL MANAGEMENT SYSTEM TO IDENTIFY GOALS, SYSTEMS, MEASUREMENTS AND SAMPLING METHODS.TO SUPPLEMENT THIS POLICY WE WILL INCORPORATE SOURCE REDUCTION THROUGH REUSE, RECYCLING, MATERIAL SUBSTITUTION, NEW AND IMPROVED TECHNOLOGIES, CREATIVE MANAGEMENT AND OPERATIONAL PRACTICES.
TO MAINTAIN THIS POLICY WE WILL PERFORM MANAGEMENT REVIEW, REVENTATIVE MAINTENANCE, EMPLOYEE TRAINING, AND A COMMITMENT AND INVOLVEMENT FROM OUR EMPLOYEES AND MANAGEMENT TO SUPPORT THIS POLICY.

ISO 14001 ENVIRONMENTAL ASPECTS AND IMPACTS

ISO 14001 Environmental Aspects And Impacts
The fundamental purpose of the EMS is to control and reduce the environmental impacts of your facility’s processes and products. For this reason, a critical element of the EMS involves identifying and prioritizing the environmental aspects and impacts associated with your facility. An environmental aspect is an element of an organizations activities, products, or services that can interact with the environment. For example, chrome plating is a metal finishing activity and an associated aspect is chrome air emissions.This aspect may have an impact on the environment in several ways, for example, ambient air quality degradation.The environmental aspects and impacts of your metal finishing operations can be identified, prioritized, and documented in several ways. This Template includes two approaches, either of which can be used during EMS implementation. Use the approach that works best for your circumstances. This process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established.
Aspects and Impacts Form A — The first approach uses the experience and judgment ofemployees familiar with facility processes to identify the top five environmental issuescurrently facing the facility. These issues and their specific aspects and impacts shouldbe summarized using Aspects and Impacts Form A.
Aspects and Impacts Form B — The second approach uses detailed, structured matricesto list and prioritize environmental aspects and impacts according to the followingcategories:• Environmental Aspects and Impacts: Wastewater• Environmental Aspects and Impacts: Air Emissions• Environmental Aspects and Impacts: Hazardous and Solid Waste• Environmental Aspects and Impacts: Raw Materials• Environmental Aspects and Impacts: Water and Energy
The matrices that comprise Form B will help facility staff identify and document environmental aspects and impacts. The matrices also provide criteria for prioritizing environmental aspects and impacts; this process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established. One possible way to prioritize environmental aspects and impacts using Form B is described as follows:Step 1:For each aspect and impact, score each prioritization criterion on a scale from 1 to 5, where 1 indicates the criterion is very important or relevant to that aspect (for example, the aspect is strictly regulated, is the subject of compliance violations, or is a waste generated in large uantities), and 5 indicates the criterion is relatively unimportant or irrelevant to that aspect (for example, the aspect is an unregulated waste, is generated infrequently, and is inexpensive to manage).Step 2:Add the scores of all criteria for each aspect and write the total in the right-most column of the form.This number indicates the relative priority of the aspect compared to other aspects and impacts in the same category. The lower the total score, the higher the priority.Purpose Of This procedure is used to identify, document, and update the environmental aspects and impacts of facility processes and operations.
Step 1 The environmental manager and other facility personnel selected by the environmental manager are responsible for identifying and prioritizing the environmental aspects and impacts of facility operations during EMS planning and development.Environmental aspects are characteristics of facility processes and products that interact with the environment. Only environmental aspects the company can control or influence will be considered. Environmental impacts are the effects of an organization’s activitie , products or services on the environment.
Step 2 Environmental aspects and impacts will be documented and prioritized.Environmental aspects and impacts will be associated with the following categories:• Wastewater• Air emissions• Hazardous and solid waste• Raw materials• Water and energyHigh-priority environmental aspects and impacts will be considered when environmentalobjectives and targets are set.
Step 3 The environmental manager and other facility personnel will review and updatethe environmental aspects and impacts documentation annually.
Step 4 Environmental aspects and impacts documentation will be retained at the facilityfor at least 2 years.
Responsible Person: _____________________________________Signature and Date: ______________________________________

Elements of the Six Sigma Framework

Elements Of The Six Sigma Framework
Management strategies, such as TQC, TQM, and Six Sigma, are distinguished from each other by their underlying rationale and framework. As far as the corporate framework of Six Sigma is concerned, it embodies the five elements of top-level management commitment, training schemes, project team activities, measurement system and stakeholder involvement.
Stakeholders include employees, owners, suppliers and customers. At the core of the framework is a formalized improvement strategy with the following five steps: define, measure, analyse, improve and control (DMAIC) which will be explained in detail in Section 2.3. The improvement strategy is based on training schemes, project team activities and measurement system. Top-level management commitment and stakeholder involvement are all inclusive in the framework.
Without these two, the improvement strategy functions poorly. All five elements support the improvement strategy and improvement project teams. Most big companies operate in three parts: R&D, manufacturing, and non-manufacturing service. Six Sigma can be introduced into each of these three parts separately. In fact, the color of Six Sigma could be different for each part. Six Sigma in the R&D part is often called “Design for Six Sigma (DFSS),” “Manufacturing Six Sigma” in manufacturing, and “Transactional Six Sigma (TSS)” in the non-manufacturing service sector. All five elements are necessary for each of the three different Six Sigma functions. However, the improvement methodology, DMAIC, could be modified in DFSS and TSS. These points will be explained in detail in Sections 2.6 and 2.7.2.2 Top-level Management Commitment and Stakeholder Involvement
(1) Top-level management commitment
Launching Six Sigma in a company is a strategic management decision that needs to be initiated by top-level management. All the elements of the framework, as well as the formalized improvement strategy, need top-level management commitment for successful execution. Especially, without a strong commitment on the part of top-level management, the training program and project team activities are seldom successful. Although not directly active in the day-to-day improvement projects, the role of top-level management as leaders, project sponsors and advocates is crucial. Pragmatic management is required, not just lip service, as the top-level management commits itself and the company to drive the initiative for several years and into every corner of the company.
There are numerous pragmatic ways for the CEO (chief executive officer) to manifest his commitment. First, in setting the vision and long-term or short-term goal for Six Sigma, the CEO should play a direct role. Second, the CEO should allocate appropriate resources in order to implement such Six Sigma programs as training schemes, project team activities and measurement system. Third, the CEO should regularly check the progress of the Six Sigma program to determine whether there are any problems which might hinder its success. He should listen to Six Sigma reports and make comments on the progress of Six Sigma. Fourth, he should hold a Six Sigma presentation seminar regularly, say twice a year, in which the results of the project team are presented and good results rewarded financially. Finally, he should hold a Champion Day regularly, say once in every other month, in which Champions (upper managers) are educated by specially invited speakers and he should discuss the progress of Six Sigma with the Champions.
It is also the responsibility of top-level management to set “stretch goals” for the Six Sigma initiative. Stretch goals are tough and demanding, but are usually achievable. Some companies set the stretch goal for process performance at 6 sigma or 3.4 DPMO for all critical-to-customer characteristics.
However, the goals can also be set incrementally, by stating instead the annual improvement rate in process performance.
The industry standard is to reduce DPMO by 50% annually.
(2) Stakeholder involvement
Stakeholder involvement means that the hearts and minds of employees, suppliers, customers, owners and even society should be involved in the improvement methodology of Six Sigma for a company. In order to meet the goal set for improvements in process performance and to complete the improvement projects of a Six Sigma initiative, top-level management commitment is simply not enough. The company needs active support and direct involvement from stakeholders.
Employees in a company constitute the most important group of stakeholders. They carry out the majority of improvement projects and must be actively involved. The Six Sigma management is built to ensure this involvement through various practices, such as training courses, project team activities and evaluation of process performance. Suppliers also need to be involved in a Six Sigma initiative.
A Six Sigma company usually encourages its key suppliers to have their own Six Sigma programs. To support suppliers, it is common for Six Sigma companies to have suppliers sharing their performance data for the products purchased and to offer them participation at in-house training courses in Six Sigma. It is also common for Six Sigma companies to help small suppliers financially in pursuing Six Sigma programs by inviting them to share their experiences together in report sessions of project team activities. The reason for this type of involvement is to have the variation in the suppliers’ products transferred to the company’s processes so that most of the process improvement projects carried out on suppliers’ processes would result in improvement of the performance.
Customers play key roles in a Six Sigma initiative. Customer satisfaction is one of the major objectives for a Six Sigma company. Customers should be involved in specific activities such as identifying the critical-to-customer (CTC) characteristics of the products and processes. CTC is a subset of CTQ from the viewpoint of the customers. Having identified the CTC requirements, the customers are also asked to specify the desired value of the characteristic, i.e., the target value and the definition of a defect for the characteristic, or the specification limits. This vital information is utilized in Six Sigma as a basis for measuring the performance of processes. In particular, the R&D part of a company should know the CTC requirements and should listen to the voice of customers (VOC) in order to reflect the VOC in developing new products.