Quality records

A note in clause 4.16.1 points out that disposition of quality records includes disposal and that quality records include customer-specified records. 

Production part approvals, tooling records, etc shall be maintained for the length of time that the part is active for production plus one calendar year, unless otherwise specified. This requirement, although removed, is implicit in the new requirement for record retention. However, the note on including purchase orders as quality records is removed, implying that they are not considered quality records but are documents and retained until obsolete. 

Are quality records collected, indexed, accessed, filed, stored, maintained, and dispositioned in accordance with documented procedures ... 

Is the retention time for quality records established and recorded ... 

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

The requirement does not cross refer to clause 4.16 on Quality records, clearly indicating that there is no requirement in this clause for problems to be recorded, as other clauses such as 4.10, 4.13, and 4.14 cover this. However, these clauses only relate to problems in not meeting the specified requirements and therefore may exclude types of problems not governed by specified requirements. So having identified the responsibilities of these personnel there may be no compulsion to provide a means for such problems to be documented, resolved, and prevented from recurrence. 

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... 

To determine the procedures you need you should design the system from the top down. Some requirements will apply to many operations such as document control, corrective action, and quality records whereas other requirements may apply to only one operation, such as auditing and management review. A matrix showing this relationship is given in Appendix D. 

Risky suppliers, i.e. single-source suppliers or suppliers with a poor quality record for which there is no alternative... 

While procedures should define the quality records that are to be produced, these are the records that will be produced if these procedures are used. On particular contracts only those procedures that are relevant will be applied and therefore the records to be produced will vary from contract to contract. Special conditions in the contract may make it necessary for additional quality records. Records represent the objective evidence with which you are going to demonstrate compliance with the contractual requirements. It would therefore be expedient, although not essential, to list all the records that will be produced and where they will be located. The list does not need to detail every specific record, providing it identifies types of records and all new records to be produced. 

How do you identify and prepare any new quality records that are needed to meet specified requirements ... 

The requirements of clause 4.5 therefore apply to policies and practices, derived documents, and external documents that are prescriptive but not descriptive. The descriptive documents are covered by clause 4.16 on quality records. 

The procedures that require the use or preparation of documents should also specify or invoke the procedures for their control. If the controls are unique to the document, they should be specified in the procedure that requires the document. You can produce one or more common procedures which deal with the controls that apply to all documents. Although ISO 9001 does not address all controls under clause 4.5, the provisions of clause 4.16 relating to the identification, access, filing, and storage of quality records are equally appropriate to documents in general and should be applied although it is not mandatory. 

The standard requires suppliers to define the type and extent of control exercised bp the supplier over subcontractors and goes on to require that these controls be dependent upon the type of product, the impact of the product on the quality of the final product, and, where applicable, on the quality audit reports and/or quality records of the previ-ousty demonstrated capability and performance of subcontractors. 

This clause requires the designation of special characteristics that should have been accomplished during product realization (as required by clause 4.2.4.7). As for the documentation of special characteristics, the symbols should have been applied both when establishing the process controls and preparing the control plan (also clause 4.2.4.7) and associated documentation during the planning phase. Therefore the requirements not previously addressed are for the control of special characteristics and evidence of compliance i.e. quality records. 

Quality records are those records identified in Chapter 16. This is a bit of a catchall as concessions, service reports, customer complaints, and data from processes and work operations are all quality records. However, the standard does not cross refer to clause 4.16 at every mention of records or similar document and therefore the requirements of 4.16 only apply in those cases where it is referenced. Service reports, for instance, do not need to comply with the requirements of clause 4.16. 

Regarding quality records, you will need to be selective and choose for analysis those which will yield some useful data. Don t embark upon a progressive analysis without good reason as it can be a fruitless exercise. 

Throughout the standard, various clauses reference the clause on quality records. To avoid repetition, the common requirements for quality records are assembled under one heading. The requirements, however, are not limited to those clauses in which this requirement is referenced as many other clauses refer to records. However, as all clauses will generate some documentary evidence it should not be assumed that all such documents are quality records. The requirements, however, apply only to original records and not to any copies other than those taken for security reasons or copies of subcontractor records. There are several types of document used in a quality system and only some are classified as quality records. As quality records are documents it might be assumed that the requirements of clause 4.5 on document and data control apply to quality records. As clause 4.16 is not cross referenced in clause 4.5 (except for clause 4.5.2.2), there is clearly no requirement for you to apply the requirements for document control to quality records. (See also Part 2 Chapter 5.) Figure 5.2 illustrates the difference between quality records and documents. 

Figure 16.1 Clause relationships with the quality records element...

Procedure change records (clause 4.14.1.1) - these are not quality records (see below)... 

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 ... 

It is advisable to identify all your quality records within your procedures. This will avoid arguments on what is or is not a quality record, because once you have chosen to identify a record as a quality record you have invoked all the requirements that are addressed in this chapter. Any document which describes the achieved features and characteristics of a product or service are quality records. Those records which will demonstrate that work has been planned, organized, resourced, monitored, verified, and corrected when found deficient are also quality records. The note following the requirement acknowledges that quality records can be in hard copy or held on a computer disk or magnetic tape. Should both forms be held, you will need to declare which are the masters and provide the appropriate security to prevent inadvertent loss or damage (see below). 

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). 

If a quality record was intended to be any document generated or used by the quality system, the definition would surely have indicated this. If we decompose the definition further, requirements for quality are defined in ISO 8402 as the expression of the needs or their translation into a set of quantitatively stated requirements for the characteristics of an entity to enable its realization and examination. Clearly, such a requirement would be a contract, product specification, design requirement, etc. This implies that any product verification records are quality records, but it rules out any recorded information as being a quality 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. 

The standard requires the supplier to establish and maintain documented procedures for the identification of quality records. 

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