Quality systems documentation

Quality System Documentation. Quahty system documentation has two aspects. One is the development of a quahty manual, which is a... 

A note in clause 4.2.1 states that all the quality systems documents should be controlled. 

A signed statement by management without its approval to the quality system documented policies and procedures will indicate that it is not committed to honoring the policies and procedures. Managers need to approve the documents within the quality system that prescribe activities for which they themselves are responsible. This serves to demonstrate that they agree with the manner in which the policy has been interpreted and are prepared to provide the resources needed to implement the documented practices. 

Some organizations divide their quality system documentation into three levels a quality manual, a set of operating procedures, and the support documentation. 

The 1987 version of ISO 9001 required the quality policy and the quality system procedures and instructions to be documented, clearly identifying three levels of documents in practice, organizations produced an intermediate level between the quality policy statement and the procedures which addressed the requirements of the standard and cross-referenced the associated procedures. This intermediate level together with the quality policy statement was often referred to as the quality manual. However, some manuals merely paraphrased the requirements of the standard, some described the quality system, and others confined the manual to the organization s operational policies. The guidance given in clause 5.3.1 of ISO 9004-1 suggests that the quality system documentation consists of policies and procedures. Clearly these policies are of a somewhat lower level than the corporate quality policy addressed in Part 2 Chapter 1. 

It would be sensible to document your quality policies separately from your quality objectives and keep these separate from the other quality system documentation. A solution is to have ... 

Keep the quality system documents updated with the needs of the business. 

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. 

The standard doesn t require a procedure for Management Review and while it does require procedures for Design Control it does not specify that a Design Review Procedure is required. The phrases consistent with and in accordance with have the same meaning as both imply compatibility and agreement. If you restrict yourself to a literal interpretation of the standard, you need produce no more than 43 documented procedures - possibly less if some aspects do not apply to your business. You can combine several procedures in one document, the size of which depends on the complexity of your business. The more complex the business the greater the number of quality system documents. The more variations in the ways that work is executed, the larger the quality system will need to be. If you have a small business and only one way of carry-... 

The standard requires all the requirements of ISO/TS 16949 to be addressed in the quality system documentation but not necessarily by individual procedures. 

This requirement acknowledges that not all the requirements of the standard can be addressed by procedures. As described previously in this chapter, quality system documentation consists of several types of documents with procedures being one type. The requirement is therefore sending out a strong message that the supplier should not produce procedures to address each element of the standard or each clause. 

Determine methods for authorizing the preparation of new quality system documents. 

Produce procedures for preparing, reviewing, approving, publishing, and distributing quality system documents. 

Produce procedures for introducing, commissioning, qualifying, changing, filing, and withdrawing quality system documents. 

Qualify quality system documents for their application. 

Don t divorce the quality system documents from other documents of your business - develop an integrated system. 

Document and data control is one of the most important aspects of the quality system. Although not the only aspect of the quality system, documentation is the foundation stone. The requirements for document and data control can be confusing because the standard doesn t specify what a document is and whether a record is a document or whether data are documents. As data is information and documents are recorded information perhaps this clause should have been headed Information control. There is often confusion also between quality system documents and quality documents and between technical documents and quality documents. There is no doubt that all documents, data, and records should be controlled but the types of control will vary depending on the type of document. 

Figure 5.1 Relationship between quality system documents...

The documents that define the calibration process themselves are derived documents and therefore will be governed by your control procedure. They do not need to be listed along with all your other control and operating procedures in the index of quality system documents. A separate index of calibration methods should be maintained. Calibration methods are like test and inspection procedures, they are product specific. 

Failure investigation procedure Nonconforming material review procedure Customer complaints procedure Quality system document change procedure Specification change procedure Maintenance procedures... 

In which documents do you record the retention times of quality records and quality system documents ... 

An audit carried out to establish that the quality system documentation adequately addresses the requirements of a prescribed standard also referred to as a documentation audit... 

The audit plan should be consistent with written quality auditing procedures included in the quality manual or other quality system documentation. The plan should include or refer to the objective criteria to be used to evaluate conformance to requirements. The plan should include or refer to other documents that will be used during the audit, including previous audit reports. If the audit is to include the review of batch or production records, such review should be conducted in accordance with a specified sampling plan or other appropriate statistical rationale as specified in a firm s quality system procedures. 

The OPCW Quality System Documents related to On-site Sampling and Analysis... 

The initial procedures for the conduct of official OPCW proficiency tests have been developed by the Special Task Force on Analytical Issues in the period 1994 to 1996, and subsequently recommended for adoption through Working Group B to the Conference of States Parties the respective procedures were adopted by the First Conference of States Parties in May 1997 (5). The evaluation criteria have been further developed since, through consultation with participants in the proficiency-testing scheme. These consultations were often initiated by practical problems posed during individual proficiency tests. The numerous amended documents have recently been compiled into three comprehensive quality system documents that describe the process of the OPCW proficiency test, which has been accredited by the Dutch accreditation body in 2001 ... 

The proficiency test requires detailed reporting of the analysis results the reporting requirements are specified in the quality system document QDOC/LAB/WI/PRO003 (8), made available to all test participants. 

The evaluation is performed in accordance with the evaluation criteria specified in the quality system document QDOC/LAB/WI/PRO003 (8) Reported spiking chemicals that meet the criteria are accredited with +1 points, whereas spiking chemicals that do not (fully) meet the criteria, for any reason, are penalized with — 1 points. The latter penalty is also used for false negative results. 

The OPCW has created the following quality system documents to control the proficiency testing. The documents are Standard Operating Procedure for the Organization of OPCW Proficiency Tests (QDOC/LAB/SOP/PT1), Work Instruction for the Preparation of Test Samples for OPCW Proficiency Tests (QDOC/LAB/WI/PT2), and Work Instruction for the Evaluation of the Results of OPCW Proficiency Tests (QDOC/LAB/WI/PT3). 

Laboratories worldwide have different facilities, instrumentation, personnel, and perhaps differing procedures, which means that each laboratory actually requires its own work instructions. These work instructions have to be included in the quality system documentation of the laboratory. In constructing work instructions, the ROPs can offer consultancy (7). In addition, there are other useful literature available discussing the methods for analysis of CWC-related chemicals and giving examples on how the laboratories have performed in round-robin tests or PTs (8 l4). 

Work Instruction for the Evaluation of the Results of OP CW Proficiency Tests, Quality System Document No. QDOC/LAB/W1 /PRO003, OPCW, The Hague, 12 August 2002. 

The excipient manufacturer should have a system to control all documents and data that relate to the requirements of the quality system. Documents and subsequent changes to the documents should be reviewed and approved by designated personnel before issuance to the appropriate areas identified in the documents. A record should be kept of where the controlled documents are located. The control should assure the issuance and removal of the appropriate document to the areas previously identified. 

The standard requires laboratories to document their policies, systems, programs, procedures, and instructions to the extent necessary to meet the requirements of customers while ensuring the quality and traceability of measurements, meaning that the laboratory determines the degree of detail found in its documentation. The laboratory must also be able to demonstrate objective evidence that the degree of detail presented in its quality system documentation is generating the desired and required outcome. Documentation must be available in a repeatable form and will normally be in either written or electronic form. 

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