Quality system subcontractors

Common quality system approach for subcontractor development... 

The standard requires the supplier to evaluate and select subcontractors on the basis of their ability to meet subcontract requirements, including the quality system and any specific quality assurance requirements. 

This would check the certification status of the quality system, verifying that any certification was properly accredited. For non-ISO 9000 registered subcontractors, a quality system assessment may be carried out at this stage either to ISO 9000 or the customer s standards. 

A specification of the requirements which will give you an assurance of quality - this might be a simple reference to the appropriate ISO 9000 standard, but as this standard does not give you any rights you will probably need to amplify the requirements (see Subcontractor quality system 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 requires suppliers to perform subcontractor quality system development with the goal of subcontractor compliance to ISO/TS 16949 or an existing customer quality system requirement... 

To what extent do you steer the development of your subcontractors quality systems towards ISO/TS 16949 compliance ... 

Throughout the standard, various clauses reference the clause on quality records. To avoid repetition, the common requirements for quality records are assembled under one heading. The requirements, however, are not limited to those clauses in which this requirement is referenced as many other clauses refer to records. However, as all clauses will generate some documentary evidence it should not be assumed that all such documents are quality records. The requirements, however, apply only to original records and not to any copies other than those taken for security reasons or copies of subcontractor records. There are several types of document used in a quality system and only some are classified as quality records. As quality records are documents it might be assumed that the requirements of clause 4.5 on document and data control apply to quality records. As clause 4.16 is not cross referenced in clause 4.5 (except for clause 4.5.2.2), there is clearly no requirement for you to apply the requirements for document control to quality records. (See also Part 2 Chapter 5.) Figure 5.2 illustrates the difference between quality records and documents. 

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. 

Quality records are maintained to demonstrate achievement of the required quality and the effective operation of the quality system. Pertinent subcontractor quality records are an element of these data. 

It is not uncommon for a company to design a medical device prototype and then have it built by a company specializing in electronic manufacture. Where this happens, as in our case, a number of suitable companies should be considered for the project, and those shortlisted should be audited for capability. Selection would depend on the quality system in place, previous experience in medical device manufacture, control of subcontractors, level of testing supplied, and the amoimt of in-house technical support available. It is advisable to ensure that a legal agreement, Quality Plan, and User Requirements Specification (URS) are employed to secure production standards for the device. 

The ISO 9002 Quality System—Model for Quality Assurance in Production, Installation and Service applies to manufacturers, distributors, and service vendors whose products have been designed and serviced by a subcontractor. Such companies are exempt from design control requirements. Both ISO 9001 and ISO 9002 are directly applicable to cGMPs. The connection between the two independent systems is shown in Table 5. Except for language, shades of meaning, and stresses the documents are similar. 

Given these perceived advantages, industry naturally prefers to use analytical methods which conform to predefined standards, particularly if critical measurements are to be made on key products. In fact the need for documentary standards in all types of analysis can only increase in the near future, since the number of companies adopting quality systems, such as ISO 9000, is increasing every year. A major reason for the adoption of this type of quality system is that companies which already have ISO 9000 certification tend to favor the use of suppliers/subcontractors who also have some form of accreditation. Therefore, companies which do not adopt a recognized quality system may find their business opportunities reduced in the near future. For better or for worse, conformance to an ISO 9000-type quality system may become e.s.sential. 

GR-6.2.2.3 Subcontractor Control. The subcontractor services shall be controlled by the processes of procurement, quality review, and surveillance, including receiving inspection, supported by the proper documentation. The subcontractor shall provide a Quality Control System (manual), documented procedures, and applicable work instructions. The construction organization shall be responsible for approval of all subcontract services. 

A quality audit consists of an examination and assessment of all or part of the system of quality assurance. It must be carried out by a specialist or a team designated for that purpose it may also be extended, if need be, to suppliers and subcontractors. 

Systems Thinking. We continuously evaluate our own operations and those of our partners to ensure compliance with the highest business standards, safety, quality and environmental matters. Principal subcontractors are invited once a year to a joint safely briefing, which covers the latest safety topics, gives feedback on the development of supplier safety and states the targets ... 

The tool vendor has essential impact on engineering (4a), use, and maintenance (3b) activities related to a production system. He provides engineers with software tools that are needed to create engineering artifacts, access plant components at commissioning and runtime, and enable device diagnosis. The capabilities and quality of the software tools have essential impact on the efficiency and quality of the activities they are applied within. Therefore, the software tool users (plant maker, plant operator, plant maintainer, supplier, and subcontractor) will provide the tool vendor with requirements toward tool capabilities resulting from their special application conditions. The described network of interactions between the different stakeholders is depicted in Fig. 2.7, which represents also the flow of information between the different stakeholders. 

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