Auditing the Quality System

When looking at one-time problems, it is important to consider whether this could have directly led to an undesired consequence, such as an accident or incident or a noncompliance situation, or if there is another level of safeguard. If it is concluded that the problem or weakness could have directly led to an undesired consequence, the system design should be reviewed to find a way in which a safeguard can be provided. Systematic issues require a redesign of the system to remove the potential for the problem. 

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Auditing the quality system (internal) Economics - Quality-related cost considerations V... 

Auditing the quality system ensures that performance is regularly reviewed and deficiencies identified and action to address these required. 

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 ... 

While the plan itself is not auditable by third parties, it may be auditable by second parties i.e. customers. The third party or registrar is entitled to examine the plan to ascertain that it is what it proclaims to be. The particulars are of no concern except those aspects relating to quality, such as the resources, quality objectives, customer satisfaction plans, and performance metrics. Whatever is stated on these aspects, the auditors will expect to see evidence that the business plan is not merely a wish list and that provisions have been made to enable implementation through the quality system. 

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 ... 

The requirements for internal audits apply to audits of the quality system, including the policies, practices, products, and services to which the quality system relates. They are not limited to audits of procedures. In order to determine whether the quality system is effective in maintaining control, you need to check that the resultant products and services meet the specified requirements and that prescribed quality objectives are being achieved. If the products and services are not meeting the specified requirements, or the prescribed objectives are not being achieved, something is clearly amiss with the quality system. The requirements do not apply to audits of suppliers or subcontractors as they are covered in clause 4.6 of the standard. 

The system audit to verify that the quality system complies with the appropriate part of ISO 9000. The system audit is a composite of a documentation audit and implementation audit (see below). This is now required in ISO/TS 16949 clause... 

Audits of practice against procedure or policy should be recorded as they are observed and you can either do this in note form to be written up later or directly onto observation forms especially designed for the purpose. Some auditors prefer to fill in the forms after the audit and others during the audit. The weakness with the former approach is that there may be some dispute as to the facts if presented some time later. It is therefore safer to get the auditee s endorsement to the facts at the time they are observed. In other types of audits there may not be an auditee present. Audits of procedure against policy can be carried out at a desk. You can check whether the documents of the quality system satisfy all the clauses of the standard at a desk without walking around the site, but you can t check whether the system is documented unless you examine the operations in practice. There may be many activities which make the system work that are not documented. 

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... 

An audit carried out to establish whether the quality system conforms to a prescribed standard in both its design and its implementation. 

Sec. 820.22 Quality audit - Conduct regular audits of the quality system... 

The relationship between the main subsystems and other minor systems is illustrated schematically in Figure 12.4. This places management at the core of the quality system, with the other systems arranged as major and minor satellites that revolve around it. This perspective provides the basis for the Quality System Inspection Technique (QSIT), which the FDA uses for auditing medical device facilities. This is based on a top-down approach, which starts with management controls and then looks at three other key subsystems of Design Controls, Corrective and Preventative Actions (CAPA) and Production and Process Controls. The belief is that by focussing on just these four subsystems, you will actually touch on all the other subsystems and obtain a sufficiently satisfactory overview of the state of compliance of the facility. 

The audit also emphasizes the self-regulated nature of the industry and the ideal relationship between the agency and the industry. In theory and effective practice, a biomedical company utilizes its quality assurance (QA) unit (in this case, supplemented by credible Part 11 auditors) to maintain control of safety, effectiveness, and quality. The FDA can then review the quality system (QS) and spot-check the other systems such as laboratory or production for most efficient regulatory oversight. In effect, the QA regulates the company and the FDA regulates the QA. 

Two important aspects are internal audits and product quality review. Internal audits are implemented to regularly monitor the compliance activities in drug manufacture and to ensure rectification to these activities if deviations occur. Trending and statistical analysis of data provide early warning of impending problems. Product quality review checks the relevance and adequacy of the manufacturing activities. It provides input to update and improve the quality system. 

Quality System This consists of procedures and specifications to assure the overall compliance for the facility. Quality control, change control, batch release, internal audits, and quality records are part of the quality system. 

The Full Inspection Qption is a surveillance or compliance inspection that is thorough and gives the FDA a deep understanding of the cGMP program in a manufacturing facility. This type of inspection is conducted when the FDA has little knowledge about the facility, such as a new facility or where the facility has a history of noncompliance or when the FDA has doubt about the facility s quality system. The Full Inspection Qption audits at least four systems in the facility, one of which must be the quality system. 

The Abbreviated Inspection Option is a surveillance or compliance inspection. It is a shortened inspection. This is performed when the facility has a satisfactory cGMP compliance record and there are no product problems or there has been little change since the last inspection. At least two systems are audited, including the quality system. 

It has to be shown by means of internal audits, that the operation (i.e. the daily work in the laboratory) is in compliance with the quality system. This must be stated in the quality manual A schedule has to be defined and a standard procedure for internal audits has to be prescribed. 

For all products in Classes Ila, lib and III, and AIMDs, a full quality assurance system, audited periodically by a notified body (Annex II of the MDD), which includes examination and certification by the notified body of the design dossier of each product covered. The manufacturer must keep documentation on the quality system and the design dossier of each product plus other documentation. The quality system obligations include post-marketing and vigilance aspects. Compliance with Annex II may be achieved (this is not mandatory but is invariably adopted voluntarily) by compliance with the EN 29000... 

Current quality system models call for audits to be conducted at planned intervals to evaluate effective implementation and maintenance of the quality system and to determine if processes and products meet established parameters and specifications. International standards provide guidance on auditing [13]. Audit procedures should be developed and documented to ensure that the planned audit schedule takes into account the relative risks of the various quality system activities. Factors that can be incorporated into a risk-based approach to planning audit frequency and scope include the following [6] ... 

Different audit approaches may be applied depending on the intended purpose and scope of the audit. A top-down approach first evaluates the overall structure of the quality system and its subsystems. Selected subsystems may be chosen for review. Systems identified and developed by the FDA in a six-system inspection model for the inspection of drug manufacturers [15] include the following ... 

Manufacturers implementing a quality system that conforms to an existing standard may find it helpful to create a table or some other document that shows the relationship between cGMP requirements, requirements of the standard, and the element(s) of the manufacturer s quality system. Such a tool can help assure that all pertinent requirements are covered in the quality system design and that audit plans designs include assessment of all pertinent requirements. 

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