Third party assessment

The certification business has grown enormously in the last ten years. The International Accreditation Forum (lAF) recorded 616 accredited certification bodies in January 1999. The experience of the vehicle manufacturers with ISO 9000 certification led them to question the wisdom of so many certification bodies chasing the same business in a competitive market. The results seemed to indicate that cost reductions by the certification bodies led to a decline in the quality of auditing and that was the opposite of what the vehicle manufacturers wanted. The vehicle manufacturers had not seen a significant rise in product quality as a result of ISO 9000 and they believed this was partially due to the quality of the accreditation and certification schemes being operated as well as inadequacies in the quality system standard. When the four national automotive schemes were launched, great emphasis was placed on regulating more closely the accreditation and certification schemes. From a customer perspective, the ISO 10011 scheme had some particular problems  

In brief, the auditor has to be qualified by lATF to perform the audits and, to be eligible for qualification, the auditor has to be sponsored by an lATF-approved certification body that is subject to witness audits performed by qualified auditors from vehicle manufacturers. Such measures will inevitably improve the quality of certification offered by certification bodies and will be good for the global automotive industry. 

The trade associations that are members of lATF perform an assurance function and have set up a panel to administer certification activities in their country. This involves witness audits of certification bodies to verify that they are adhering to the lATF agreement. They will monitor the scheme on behalf of the vehicle manufacturers in ensuring that certificates are only awarded to organizations that are 100% compliant with the requirements. These activities should provide added confidence that the certification bodies are fulfilling their obligations. 

The trade associations will also process applications for lATF recognition and for auditor qualification. A central database of auditors will be maintained so that auditor competency can be monitored. Auditor qualification and re-qualification results, complaints, and movements will be stored so that the validity of auditor certificates can be ascertained. 

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  

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Third-party assessment and responsibility I, Documentation (central and local)... 

As shown above, these include a laboratory to be third-party assessed to international accreditation standards, to demonstrate that it is in statistical control by using appropriate internal quality control procedures, to participate in proficiency testing schemes which provide an objective means of assessing and documenting the reliability of the data it is producing and to use methods of analysis that are fit-for-purpose . These requirements are summarised below and then described in greater detail later in this chapter. 

Section 1 Formal quality system in the laboratory if third party assessed (i.e. if UKAS accredited or GLP compliant)... 

ISO 9000 requires what is called a third party assessment but involves developing first and second party strategies. First party refers to the supplier company that requests ISO 9000 certification. Second party refers to the customer whose needs have been met by the first party through the use of quality management procedures achieved by ISO 9000 compliance. Third party refers to an outside reviewer who certifies that the first party has satisfied ISO 9000 procedures. 

Keywords Amount of substance standards Chemical composition standards Traceability Third party assessment Primary reference materials... 

One of the principal elements of Green Zia that will be the focus of this paper is the third-party assessment and feedback report process. Like our Baldrige brethren at both the national level and at the state Quality Award Program level, Green Zia employs a number of volunteers to read applications that are submitted to our state Environment Department, provide nonprescriptive feedback on strengths and opportunities for improvement, determine a score for the application based on a 1000-point scale, and possibly conduct a site visit to verify/clarify the application. This paper will describe all aspects of the third-party examination process and will provide some personal insight as to the strengths and opportunities for improvement of our own process. 

Prior use assessment is the responsibility of an end user. However some manufacturers are working to help their customers in prior use evaluations by providing hiformation. Some manufacturers have had a third party assessment of the field failure records that exist for a device. Failures attributable to both hardware and software are considered. As part of this process an assessment must also be made of the field return data gathering procedures and the product modification process. 

Commercial pressures and legislation are both certain to increase the requirement for third-party assessment and registration of laboratory QA arrangements, whether to ISO 17025, ISO 9000, GMP, or GLP. 

The test plans, procedures, expected results and reports on the tests should be maintained and should be available for quality assurance audits and third party assessments. The test procedures should present the rationale for each test case and provide for tracing of the test cases to the relevant source documents. The expected test results should be stated (with their method of derivation) in the test documentation prior to execution of the tests. 

Full and accurate records of operation of the system should be maintained by the hcensee and should be available for third party assessment. These records should include information on all maintenance activities (including preventive and corrective actions), in-service testing and anomalies observed during operation of the... 

Third-party assessments are conducted by an outside resource selected or designed to provide an unbiased view of the system. While internal self-assessments are an essential part of the... 

It has to be acknowledged that third-party assessment does involve additional cost for perhaps little significant added value in terms of actual safety integrity. Provided that the self-assessments are conducted under a formal quality management system, with appropriate audits, and provided also that competency of the assessors in risk assessment can be demonstrated by the organization, then there is no reason why such assessment should not be both credible and thus acceptable to clients and regulators. 

Proactive involvement in professional institutions, industrial research organizations, or the production and development of lEC 61508 and associated standards by both self-assessors and external consultants would assist in this respect. The authors, for example, have made major contributions to the Standard and to a number of the second-tier documents described in Chapters 8—10. Thus, the credibility of third-party assessment bodies or consultants does need to be addressed vigorously. 

Independent third party assessment has become the norm, avoiding the excesses of multiple assessments and providing periodic surveillance of QM. 

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