Thursday, November 26, 2009

Establishing Quality Objectives In ISO 9001 Standards

Establishing Quality Objectives In ISO 9001 Standards
The ISO 9001 Standard requires that top management ensure that quality objectives are established.
ISO 9001 defines quality objectives as results sought or aimed for related to quality. It also suggests that these objectives be based on the quality policy and be specified at different levels in the organization, being quantified at the operational level. As with quality policy the details will be addressed later and here we will focus on what it means to establish qualityobjectives and how they relate to other objectives.
As the quality policy equates to the corporate policy, it follows that quality objectives equate to corporate objectives. All of the organization’s objectives should in some way serve to fulfil requirements of customers and other interested parties. It is also interesting to note that inISO 9001, the term requirement is defined as a need or expectation that is stated, customarily implied or obligatory. While an investor may not specify a requirement for growth in share value, it would certainly be an expectation. While an employee does not express requirements for salary increases when profits rise, it would certainly be an expectation and while society has no way other than to protest or invoke the law to impose its desires upon an organization, it certainly has the power to make organization’s comply and even change the law in extreme cases. So quality objectives do equate to corporate objectives.
Management needs to ensure that the objectives are established as a basis for action. All work serves an objective and it is the objective that stimulates action.
The reason for top management setting the objectives is to ensure that everyone channels their energies in a positive direction that serves the organizations purpose and mission.
For an objective to be established it has to be communicated, translated into action and become the focus of all achievement. Objectives are not wish lists. The starting point is the purpose and mission statement and the factors
identified as affecting the ability of the organization to accomplish its mission. It is in these areas the organization needs to excel and therefore they become the focus for action and consequently the setting of objectives. Although ISO 9001 suggests that the quality objectives should be based on the quality policy, it is more likely to be current performance, competition and opportunities arising from new technology that drive the objectives.
An objective is a result that is aimed for and is expressed as a result that is to be achieved. Objec-
tives are therefore not policies. The requirement should also not be interpreted as applicable only to
organizational functions and levels. Objectives are required at levels within the organization not levels
within the organization structure. This is clarified by the requirement for objectives to include those
needed to meet requirements for product. There are therefore five levels at which control and improve-
ment objectives need to be established:
Corporate level where the objectives are for the whole enterprise to enable it to fulfil its vision
Process level where the objectives are for specific processes to enable them to fulfil corporate goals
Product or service level where the objectives are for specific products/services or ranges of products/services to enable them to fulfil or create customer needs and expectations
Departmental or function level where the objectives are for an organizational component to enable it to fulfil corporate goals Personal level where the objectives are for the development of individual competency
A management system is not a static system but a dynamic one and if properly designed and implemented can drive the organization forward towards world class quality. All managerial activity is concerned either with maintaining performance or with making change. Change can retard or advance performance. That which advances performance is beneficial. In this regard, there are two classes of quality objectives, those serving the control of quality
(maintaining performance) and those serving the improvement of quality (making beneficial change).
maintain or to prevent from deteriorating. To maintain your performance and your position in the market you will have to continually seek improvement.
Remaining static at whatever level is not an option if your organization is to survive. Although you will be striving for improvement it is important to avoid slipping backwards with every step forwards. The effort needed to prevent regression may indeed require innovative solutions. While to the people working on such problems, it may appear that the purpose is to change the status quo, the result of their effort will be to maintain their present position not raise it to higher levels of performance. Control and improvement can therefore be perceived as one and the same thing depending on the standards being aimed for and the difficulties in meeting them.
The statements of objectives may be embodied within business plans, product development plans, improvement plans, process descriptions and even procedures.
Achievable objectives do not necessarily arise from a single thought even when the policies provide a framework. There is a process for establishing objectives.
At the strategic level, the subjects that are the focus for setting objectives are the factors that affect the organization’s ability to accomplish its mission – the critical success factors such as marketing, innovation, human resources,
physical and financial resources, productivity and profit. There may be other factors such as the support of the community, of unions, of the media as certain businesses depend on continued support from society. Customer needs, regulations, competition and other external influences shape these objectives and cause them to change frequently. The measures arise from an analysis of current performance, the competition and there will emerge the need for either improvement or control. The steps in the objective setting process are as follows:
Identifying the need
Drafting preliminary objectives
Proving the need to the appropriate level of management in terms of:
whether the climate for change is favourable
the urgency of the improvement or controls
the size of the losses or potential losses
the priorities
Identifying or setting up the forum where the question of change or control is discussed Conducting a feasibility study to establish whether the objective can be achieved with the resources that can be applied Defining achievable objectives for control and improvement
Communicating the objectives
The standard does not require that objectives be achieved but it does require that their achievement be planned and resourced. It is therefore prudent to avoid publishing objectives for meeting an unproven need and which has not
been rigorously reviewed and assessed for their feasibility. It is wasteful to plan for meeting objectives that are unachievable and it diverts resources away from more legitimate uses.
Objectives are not established until they are understood and therefore communication of objectives must be part of this process. Communication is incomplete unless the receiver understands the message but a simple yes or no is not an adequate means of measuring understanding. Measuring employee understanding of appropriate quality objectives is a subjective process. Through the data analysis carried out to meet the requirements of clause 8.4 you will have produced metrics that indicate whether your quality objectives are being achieved. If they are being achieved you could either assume your employees understand the quality objectives or you could conclude that it doesn’t matter. Results alone are insufficient evidence. The results may have been achieved by pure chance and in six months time your performance may have declined significantly. The only way to test understanding is to check the decisions people make. This can be done with a questionnaire but is more effective if one checks decisions made in the work place. Is their judgement in line with your objectives or do you have to repeatedly adjust their behaviour?
For each objective you should have a plan that defines the processes involved in its achievement. Assess these processes and determine where critical decisions are made and who is assigned to make them. Audit the decisions and ascertain whether they were contrary to the objectives. A simple example is where you have an objective of decreasing dependence upon inspection. By examining corrective actions taken to prevent recurrence of nonconformities you can detect whether a person decided to increase the level of inspection in order to catch the nonconformities or considered alternatives.
Any person found increasing the amount of inspection has clearly not understood the objective.

ISO 9001 Standards – Design and development

ISO 9001 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.