Inspection quality system

Quality systems. Model for quality assurance in linal inspection test 1400.3/1994 BS EN ISO 9003/1994 900.3/1994... 

Quality plans are needed when the work you intend to carry out requires detailed planning beyond that already planned for by the quality system. The system will not specify everything you need to do for every job. It will usually specify only general provisions which apply in the majority of situations. You will need to define the specific documentation to be produced, tests, inspections, and reviews to be performed, and resources to be employed. The contract may specify particular standards or requirements that you must meet and these may require additional provisions to those in the quality system. Although ISO/TS 16949 requires the plan to include customers requirements, the intention is not that these requirements are reproduced if provided in a documented form by the customer, but that a cross reference is made in the plan together with any other relevant specifications referred to in the contract. However, when constructing the plan, it would make sense to refer to specific customer requirements and provide a response that indicates your intentions regarding those requirements. 

The quality of the product can only be verified by the subcontractor during its design and manufacture. (In such cases you need to rely on what the contractor tells you and to gain sufficient confidence you can impose quality system requirements, require certain design, manufacturing, inspection, and test documents to be submitted to you for approval, and carry out periodic audit and surveillance activities. This method is usually applied for one-off systems or small quantities when the stability of a long production run cannot be achieved to resolve problems.)... 

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. 

The standard provides a choice as to whether you define the inspections and tests required in a quality plan or in documented procedures. You may of course need to do both. As the quality system is often designed to accommodate all products and services you supply, it may not specify inspections and tests which are needed for particular products. This is one of the roles of the quality plan. Within such a plan you should identify the verification stages during product development, production, installation, and servicing as applicable. These stages will vary depending on the product, so your quality plan will be product, contract, or project specific (see Part 2 Chapter 2). There may... 

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. 

The standard doesn t require a procedure covering inspection and test status however, as clause 4.2 requires a documented quality system, you will need to document the methods employed to denote inspection and test status. If you use stamps you will need a register to allocate stamps to particular individuals and to indicate which stamps have been withdrawn. When a person hands in a stamp it is good practice to avoid using the same number for 12 months or so to prevent mistaken identity in any subsequent investigations. 

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 requirement may not apply to all product acceptance decisions. If your acceptance of the end product does not depend upon acceptance decisions being made on its component parts, any sampling carried out on receipt inspection or in-process is not important to the product acceptance decision and can therefore be ignored in your documented quality system. This is a wise course of action if you can be sure this will always be the case but if you can t, and more often than not you won t know, it is prudent to encompass a//sampling activities in your quality system. 

The 1982 White Paper on Standards, Quality and International Competitiveness was concurrent with increasing interest in the techniques of quality assurance and the need for international harmonization of standards and the reciprocal recognition of certification. It is worth noting that the ISO 9000 series of standards on Quality Systems 1987 followed the layout of BS 5750 1979 almost clause by clause. ISO Guide 39 covers the general requirements for inspection bodies. Auditing on behalf of certification bodies is part of the inspecting authorities role. 

The regular internal auditing of a quality system is a fundamental requirement. These audits should be conducted by persoimel independent of the operational area being audited for example a quality department should not audit its own activities. The results of such audits, together with those from outside inspection bodies, will invariably identify areas for improvement. 

Certification based on auditing against a quality system standard for design, production final inspection (e.g. ISO 13485)... 

Production QA is the process whereby the manufacturer adopts a quality system for the manufacture and final inspection of a device. ISO 13485 may also be used as the model in these circumstances, as the design and development elements may be omitted from this standard. The manufacturer must lodge an application with a Notified Body to have his/her system examined. The application must be accompanied by documentation on the quality system and information on any relevant EC type-examined devices. 

Product QA is the process whereby the manufacturer applies to a Notified Body to have his/her quality system for final inspection audited and certified. EN 46003 may be used as the harmonised standard for this model. 

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. 

Figure12.4 Quality System Regulation subsystems from the FDA guide to inspection of quality systems.

PDA Guide to Inspections of Quality Systems (QSIT Guide)... 

The owner s Inspector is responsible to the owner to verify that all required examinations, inspections, and testing are complete. The owner s Inspector verifies that all required certifications and records have been completed. Also, the owner s Inspector is responsible for verification of the construction organization s quality systems program implementation. 

Guide to Inspections of Electromagnetic Compatibility Aspects of Medical Device Quality Systems Text... 

The first and foremost element for GMP is the quality system. This can be divided into Quality Assurance (QA) and Quality Control (QC). QA is a total system approach. It sets out the compliance policies and procedures for all facets of drug manufacturing. QC is the practical extension of QA. The role of QC is concerned with inspection and testing of the manufacturing environment, raw materials, in-process intermediates, and finished products. 

It is necessary to ensure suppliers of materials have in place appropriate quality systems and that they are reliable. External audits may be required to inspect and confirm the supplier s facility and 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. 

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