Quality auditing

Some organizations have a documented quality assurance program that includes an audit program. A quality assurance program usually contains three tiers of documentation the 

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Quality Audit. Another important responsibiUty of quahty assurance is the audit function. Using the quahty audit as a tool, QA can monitor the operation of the manufacturing faciUty a toU, ie, contract, manufacturer or raw material suppHer to assure that written procedures are in place and that there is documentation to indicate the procedures are being followed. Properly executed audits allow QA to spot potential weakness in the quahty system that could allow errors to occur. Once identified, these weaknesses can then be corrected before they result in nonconformance. 

What are some pollution prevention opportunities you could focus on in an indoor air quality audit. 

The characteristics of the downstream pollution discharge must be monitored (see Fig. 13.18). It is essential that the operation and maintenance of the pollution control equipment be included in a quality audit procedure, assisting in determining the operation efficiency of the equipment and the formation of unwanted and possibly toxic compounds in the pollution control steps. Unsuitable operation of an incinerator may result in partial oxidation and formation of unwanted combustion products or excessive formation of MO. 

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). 

Are internal quality audits planned and implemented in accordance with documented procedures ... 

Planning, conducting, and reporting on internal quality audits (clause 4.17.1) Identifying training needs and providing training (clause 4.18.1)... 

The standard requires that trained personnel be assigned for management, performance of work, and verification activities including internal quality audits. 

You can determine this by providing the results of all quality audits of the system, of processes, and of products. 

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. 

Within your procedures you need to provide a means of identifying which items have been subject to inspection at the subcontractor s premises and the receipt inspection action to be taken depending on the level of that inspection. In one case, the product may have been accepted by your representative on the subcontractor s premises. In another case, a product from the same batch may have been accepted by your representative but not the one that has been delivered. Alternatively your representative may have only performed a quality audit to gain a level of confidence. You need to specify the inspection to be carried out in all such cases. The standard emphasizes that consideration should also be given to the recorded evidence provided. Even if someone has performed inspection at the subcontractor s premises, if there is no evidence of conformance the inspections are of little value. The fact that an inspection was carried out is insufficient. There has to be a statement of what was checked and what results were obtained and a decision as to whether conformance has been achieved. Without such evidence you may need to repeat some of the inspections carried out on the subcontractor s premises. 

You need to record the results of the investigations but not the corrective action you need to take. Even in clause 4.17 on internal quality audits, the requirement for the agreed corrective action to be recorded has been omitted. The results of the audit, the action taken, and its effectiveness need to be recorded but not the agreed corrective action. ISO 10011-1 does not require agreed corrective actions to be recorded either. 

Customer complaints Warranty claims Failure analysis reports Process capability studies Service reports Concessions Change requests Subcontractor assessments Performance analysis Deviations and waivers Contract change records Quality cost data External Quality Audit records... 

Figure 17.1 Clause relationships with the Internal quality audit element...

The standard requires the supplier to establish and maintain documented procedures for planning and implementing internal quality audits. 

The strategic quality audit to verify that the strategic plans of the organization address specified legal, environmental, safety, and market quality requirements. 

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. 

The standard requires that internal quality audits be carried out by personnel independent of those having direct responsibility for the activity being audited. 

By being independent of the audited activities, the auditor is unaware of the pressures, the excuses, the informal instructions handed down and can examine operations objectively without bias and without fear of reprisals. It is for this reason that it was considered appropriate for the auditor to have no direct responsibility for the work being audited i.e. audits carried out by a manager, supervisor, or foreman of his/her own department or section do not qualify as internal quality audits in ISO 9001 1994. However, they will qualify under ISO 9000 2000. 

Separate independent quality audit departments could be set up, staffed with trained auditors. 

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