Quality system effectiveness

The requirement is also somewhat duplicated in clause 4.1.3 on management reviews. You are required to conduct management reviews to ensure quality system effectiveness and conduct internal quality audits to determine the effectiveness of the system. It would appear that the audit collects the evidence and the review ensures that it is collected. 

One important aspect of the quality systems approach is the ongoing collection and analysis of quality data to continuously evaluate quality system effectiveness. Historical data, process knowledge, and risk analysis methods can be applied to identify specific data requirements. Trending and other data analysis methods can allow identification of actual and potential sources of nonconformity so that appropriate corrective and preventive actions can be taken in accordance with established change control procedures. 

Produce historical records to confirm levels of quality system effectiveness and activity/service/product achievement... 

The study shows, however, that the air curtain in the original design is bent off the wall due to the presence of the open oven with induced airflow inside the oven. This unexpected flow feature finally leads to a recirculation zone below the oven, and dust particles on the floor can be carried into the oven (class B quality). This effect was then also confirmed by smoke experiments in the real room and the existing ventilation system. 

The quantitative measure of these characteristics may be difficult if not impractical, but nevertheless they provide a means of judging the effectiveness of the system once it is installed. The effectiveness of quality systems is also addressed in Part 2 Chapter 1. 

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. 

The audit plan shall include evaluation of all supplier quality system elements for effective implementation of ISO/TS 16949 requirements as well as for effectiveness in practice. 

Do executive management establish the continuing suitability and effectiveness of the quality system through periodic reviews ... 

Are quality records maintained which demonstrate conformance to specified requirements and the effectiveness of the quality system ... 

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. 

The supplementary requirements provide a welcome addition to this somewhat inadequately specified clause of ISO 9001. However the reference to clause 4.1.1.2 with respect to objectives specified in the quality policy is somewhat ambiguous. Clause 4.1.1.2 does not require objectives to be included in the policy this is required in clause 4.1.1.1. As stated previously, system effectiveness is judged by how well the system enables implementation of policy and achievement of objectives. Therefore, requiring records that contain evidence of this is a logical interpretation. Such records need to identify the matters reviewed, the results, the actions, and the decisions taken, together with the names of those responsible and the date by which actions are to be completed. The records should also contain the data used to conduct the review as the basis upon which the decisions have been made and so that comparisons can be made at later... 

What evidence demonstrates that your quality system is suitable and effective in satisfying ISO/TS 16949 and your stated quality policy and objectives ... 

The standard does not require you to demonstrate that you meet all the requirements of the standard. It only requires a quality system to be documented, implemented, and maintained. While clause 4.16 on quality records does in fact require you to demonstrate the effective operation of the quality system, it does not dictate how you should... 

This requirement clearly defines the purpose of a quality system, that of ensuring that products conform to specified requirements. One of the principal differences between ISO 9000 and ISO/TS 16949 is the emphasis placed on internal efficiency and effectiveness. Implementing the requirements of ISO/TS 16949 will cause the waste, errors, and internal costs to be minimized. Unlike ISO 9001, ISO/TS 16949 requires the system to enable the organization to implement its quality policy and achieve its quality objectives, which after all is its purpose. This fundamental shift in concept is also behind the changes being made to ISO 9000 in the year 2000 edition. 

These are only some of the reasons for creating a quality system. Whatever your reasons are, define and document them and review them frequently. When you evaluate the system these reasons will help determine whether your system is effective (see Part 2 Chapter 17). 

The standard requires the supplier to effectively implement the quality system and its documented procedures. 

In ensuring the effective implementation of the quality system you should continually ask ... 

If the answer is Yes your system is operating effectively. If your answer is No to any of these questions, your quality system is not being effectively implemented. 

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. 

How do you ensure that the documented quality system is implemented effectively ... 

Operations essential to the effective functioning of the system are operations that contribute to the specification, achievement, control, assurance, or management of quality. Any operation covered by the quality system is an essential operation. 

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. 

These lists tell us something about the nature of quality records, especially by what is not included. Absent from the lists are policies, procedures, instructions, plans, specifications, and any other prescriptive documents. The records all have one thing in common they describe the results of some activity - the results of inspections, tests, reviews, audits, assessments, calculations, etc. However, these lists are dominated by records relating to product quality rather than to the operations of the quality system. In addition to audit records, the following records may need to be maintained to demonstrate the effectiveness of the quality system ... 

Some auditors believe that any document generated or used by the quality system is a quality record and will attempt to apply the requirements of clause 4.16. Whilst it can be argued that any documented output is a record of an activity, the reader is referred to ISO 8402 for a definition of records in the context of the quality system. ISO 8402 states that a record is a document which furnishes objective evidence of activities performed or results achieved. A quality record provides objective evidence of the fulfillment of the requirements for quality (e.g. product quality record) or the effectiveness of the operation of a quality system element (e.g. quality system record). 

Regarding the effectiveness of the quality system, the very existence of a document is not evidence of effectiveness but it can be regarded as a record. To be a quality record, the document would need to contain results of an examination into the effectiveness of the system. 

In order to demonstrate the achievement of quality and the effectiveness of the quality system, records will need to be gathered in from the locations where they were produced. This is more than a convenience because you will be unable to analyze all the data efficiently unless you need it in front of you. If you are lucky enough to operate a computer network and all the data is available on the network, data collection is a simple affair. However, many organizations still rely on paper records and therefore you will need a means of enabling such records to be either submitted to the analysis points or collected from source. To facilitate the collection of records you will need to insert submission or collection instructions in the relevant procedures which specify the records. 

The standard requires that quality records be maintained to demonstrate the effective operation of the quality system. 

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