Quality system performance

The standard requires the supplier to evaluate the performance of the quality system to verify the effectiveness of its operation. It also requires the results to be used for continuous improvement or corrective action as appropriate. 

1 Define what you want your quality system to do - define its purpose. 

2 Create a plan of how you intend to design, develop, introduce, and evaluate the quality system. 

4 Determine training needs for developing, implementing, and evaluating the quality system. 

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FDA record Quality systems Performance measures Change control... 

Are Quality Metrics in place to enable measurement of Quality System performance ... 

Any quality or performance deviations of the equipment are printed out, the system allows fully automated operator free inspection and quality assurance documentation. 

Historical DataBase Subsystem We have discussed the use of on-hne databases. An historical database is built similar to an on-line database. Unlike their on-line counterparts, the information stored in a historical database is not normally accessed directly by other subsystems for process control and monitoring. Periodic reports and longterm trends are generated based on the archived data. The reports are often used for long-term planning and system performance evaluations such as statistical process (quality) control. The trends may be used to detect process drifts or to compare process variations at different times. 

In 1991, the Verband der Automobilindustrie e. V. (VDA) published VDA 6.1, Quality Spstem Audit, a questionnaire on quality system evaluation based on DIN EN ISQ 9004. VDA 6 is a series of guides covering the basics for quality audits, auditing, and certification. They were therefore not intended as supplementary requirements to ISQ 9000 but as guides for auditors performing audits of automotive suppliers. Their intention was to improve auditor competency in the industry by providing a uniform interpretation of ISQ 9000 requirements and a common approach to automotive audits. VDA 6.1 has been revised several times and is currently in its fourth edition. There are nine volumes in the series (see Appendix A). 

Organization Level Principle Process Focus Basic Team Structure Performance Issue Focus Typical Quality System Focus Ideal Quality System Focus... 

Quality systems need to possess certain characteristics for them to be fit for their purpose. ISQ/TS 16949 specifies functional requirements for quality systems rather than performance requirements. It specifies what a quality system must do but not how well it must do it. The performance required will however depend on the environment in which the system will be used. Some of these performance characteristics will be as follows ... 

The note in clause 4.5.2.1 lists examples of documents that should be available at all locations where operations essential to the effective functioning of the quality system are performed. 

Most certification body auditors who are currently performing audits against one or more of the national automotive quality system requirements (QS-9000, VDA 6, AVSQ, or EAQF) will qualify. To qualify, auditors need to ... 

Existing automotive auditors must have performed at least 15 third party audits to one of the four automotive quality system requirements in the last three years at a minimum of 45 audit days with two of these as a lead auditor. 

The key to this requirement is determining what work affects quality i.e. if you can identify any work that does not affect quality, you are not obliged to define in your quality system the responsibilities and authority of those who manage, perform, or verify it. 

The standard requires that the supplier s management with executive responsibility appoints a member of its own management with responsibility for ensuring that quality system requirements are established, implemented, and maintained in accordance with ISO 9001, and for reporting on the performance of the quality system to management for review and as a basis for improvement of the quality system. 

Primarily, the designated person is the system designer for the quality system. This person may not produce the policies and procedures but operate as a system designer. He/she lays down the requirements needed to implement the corporate quality policy and verifies that they are being achieved. It is also necessary to have someone who can liaise with customers on quality issues, who can coordinate the assessment and subsequent surveillance visits, who can keep abreast of the state of the art in quality management. The person should be an adviser to the top management who can measure the overall performance of the company with respect to quality. 

The standard requires that the quality system be reviewed at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of ISO 9001 and the supplier s stated quality policy and objectives. There is also a supplementary requirement in clause 4.2.8 for the performance of the system to be evaluated to verify the effectiveness of its operation. 

While the plan itself is not auditable by third parties, it may be auditable by second parties i.e. customers. The third party or registrar is entitled to examine the plan to ascertain that it is what it proclaims to be. The particulars are of no concern except those aspects relating to quality, such as the resources, quality objectives, customer satisfaction plans, and performance metrics. Whatever is stated on these aspects, the auditors will expect to see evidence that the business plan is not merely a wish list and that provisions have been made to enable implementation through the quality system. 

This requirement is similar to that in clause 4.14.3 under Preventive action since the data collected for preventive action serves a similar purpose. In one case an analysis of company-level data serves to identify overall trends and predict potential failures that will affect achievement of the goals. In the preventive action case, the data serves to identify local and overall trends and predict potential failures that will affect achievement of specified requirements for the product, process, and quality system. It would be sensible to develop a data collection and analysis system that serves all levels in the organization, with criteria at each level for reporting data upwards as necessary. You should not treat this requirement separately from that for preventive action since the same data should be used. However, the explanation given in clause 4.1.5 of Operational performance does include some factors that may not be addressed in your preventive action procedures. 

A system is an ordered set of ideas, principles, and theories or a chain of operations that produces specific results to be a chain of operations, the operations need to work together in a regular relationship. A quality system is not a random collection of procedures (which many quality systems are) and therefore quality systems, like air conditioning systems, need to be designed. All the components need to fit together, the inputs and outputs need to be connected, sensors need to feed information to processes which cause changes in performance and all parts need to work together to achieve a common purpose i.e. to ensure that products conform to specified requirements. You may in fact already have a kind of quality system in place. You may have rules and methods which your staff follow in order to ensure product conforms to customer requirements, but they may not be documented. Even if some are documented, unless they reflect a chain of operations that produces consistent results, they cannot be considered to be a system. 

As stated in Part 2 Chapter 1, maintenance is concerned with retaining something in or restoring something to a state in which it can perform its required function. Quality systems comprise the organization, resources, and processes as well as the documentation needed for achieving quality, so you need to maintain more than the documentation. 

The standard only refers to procedures as the category of quality system documentation. If we use the term documented practices we have a wider choice as to the types of documents we put into the quality system. Many documents are not procedures. They do not tell us how to proceed or specify a way to perform an activity. They specify criteria we must meet or provide guidance in conducting a task. They may, however, give examples or define rules to follow. 

Quality plans are needed when the work you intend to carry out requires detailed planning beyond that already planned for by the quality system. The system will not specify everything you need to do for every job. It will usually specify only general provisions which apply in the majority of situations. You will need to define the specific documentation to be produced, tests, inspections, and reviews to be performed, and resources to be employed. The contract may specify particular standards or requirements that you must meet and these may require additional provisions to those in the quality system. Although ISO/TS 16949 requires the plan to include customers requirements, the intention is not that these requirements are reproduced if provided in a documented form by the customer, but that a cross reference is made in the plan together with any other relevant specifications referred to in the contract. However, when constructing the plan, it would make sense to refer to specific customer requirements and provide a response that indicates your intentions regarding those requirements. 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

The standard requires suppliers to perform subcontractor quality system development with the goal of subcontractor compliance to ISO/TS 16949 or an existing customer quality system requirement... 

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