Evidence, quality systems

The existing quality system requirements do have some of the above requirements but it is ISO/TS 16949 in which the full impact of their relationship is evident. It follows therefore that in making the transition from your existing system to an ISO/TS 16949 compliant system, the first step is to establish the extent to which your existing system possesses these linkages and feedback loops - a sort of coherence check to verify your system is not just a bolt-on extra. 

This can be done by providing evidence showing how business decisions have been made. Those made without using available data from the quality system show either that poor data is being produced or management is unaware of its value. 

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. 

What evidence demonstrates that your quality system is suitable and effective in satisfying ISO/TS 16949 and your stated quality policy and objectives ... 

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. 

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. 

Some auditors believe that any document generated or used by the quality system is a quality record and will attempt to apply the requirements of clause 4.16. Whilst it can be argued that any documented output is a record of an activity, the reader is referred to ISO 8402 for a definition of records in the context of the quality system. ISO 8402 states that a record is a document which furnishes objective evidence of activities performed or results achieved. A quality record provides objective evidence of the fulfillment of the requirements for quality (e.g. product quality record) or the effectiveness of the operation of a quality system element (e.g. quality system record). 

Regarding the effectiveness of the quality system, the very existence of a document is not evidence of effectiveness but it can be regarded as a record. To be a quality record, the document would need to contain results of an examination into the effectiveness of the system. 

The period between quality system assessments - assessors may wish to see evidence that corrective actions from the last assessment were taken. If the period of assessment is three years and you dispose of the evidence after two years, you will have some difficulty in convincing the assessor that you corrected the deficiency. 

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. 

Quality System shall provide for control of material and product identification during all stages of production and delivery. Identification is based on applicable drawings, specifications, or other documents. When required or specified, complete traceability of material or product shall be maintained by issuing unique or batch control numbers and/or markings. The identification and trace-ability procedure shall be fully documented to provide objective evidence of compliance with this Code in accordance with this requirement. 

Software validation is not separately defined in the quality system regulation. The FDA considers software validation to be the confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled [14]. Software validations have special concerns on software installation, implementation, and utilization. A software validation consists in several tests, inspections, and verifications performed to assure the adequate installation and use of software and that the tasks performed meet all the specifications defined. Software validations must be performed under the environmental conditions to which software will be submitted. This is particularly important in medical devices that are used under special conditions, such as close to or inside the human body. 

The international standard ISO 9003 1994 was established by Technical Committee ISO/TC 178, and is based on British standard 5750 1987 series, European standard EN 29000 1987 series, and international standards ISO 9000 1987 series. The standard was adopted by the company to provide objective evidence that the company s operations of final product inspection and testing are in compliance with the requirement of this standard. However, this third edition canceled and replaced the second edition (ISO 9003 1994). The quality manual QM-4 is revised in accordance with the corresponding changes specified in the third edition of ISO 9001 2000 to specify quality system requirements for use where a contract between the company and customer requires the demonstration of capability of final product inspection and testing with customer satisfaction. The permissible exclusions are made to ... 

A decision not to perform the review (e.g., evidence that code is developed under a quality system and formal reviews have already been conducted and reported) should be documented in the project validation plan, complete with the rationale. It is recognized that under its software quality assurance program the supplier may conduct similar examination of the software using only internal resource. Considering GMP implications, the pharmaceutical manufacturer would normally require that the software designer or programmer does not carry out any software review in isolation. 

Complaints related to the quality of the product should also be evaluated. Complaint trends should be reviewed for evidence that recurring problems have been adequately resolved. The complaint trends should be examined for any correlation to the other quality systems. For example, any correlation between complaints and deviations related to the same lot or product line or any-increase (or lack of a decrease) in complaints after a corrective action has been made should be revealed and addressed during the APR process. 

The benefit derived from correlating significant and compatible information provided by the quality systems become very apparent when a comprehensive APR system has been operational for a while. The relationship between the various quality markers becomes evident and helps to facilitate the development of more concise short and long-term improvements. 

A quality audit is an inspection made on a selected area of the laboratory, or of the quality system, in order to obtain objective evidence of the extent to which the planned arrangements for achieving and maintaining quality are met, and indeed whether or not they are adequate. Audits must ensure that day-to-day operations comply with the requirements of the system. (Is the laboratory doing what it says it does )... 

The emphasis of inspections is moving away from particular products toward general operational capability. This move was hrst evident in the Quality Systems Inspection Technique (QSIT) adopted by the FDA for medical device inspections in January 2000. Companies are considered out of control if any one of the main quality management controls inspected is found noncompliant with regulatory requirements ... 

After reviewing model quality systems like ISO, Malcolm Baldrige, or the European Quality Award, it is evident that cGMPs fall short of being a true quality system. They lack many elements common to these quality models such as leadership, planning, process orientation, and continuous improvement. A corollary concern is sometimes expressed that the pharmaceutical business is so regulated that a best practice quality system like ISO is not sufficient. However, a central... 

If any omission by the manufacturer in the initial evaluation procedure, or during the follow-up activities, is evident in relation to the requirements, including compliance with quality system standards and failure to notify complaints. 

The standard requires laboratories to document their policies, systems, programs, procedures, and instructions to the extent necessary to meet the requirements of customers while ensuring the quality and traceability of measurements, meaning that the laboratory determines the degree of detail found in its documentation. The laboratory must also be able to demonstrate objective evidence that the degree of detail presented in its quality system documentation is generating the desired and required outcome. Documentation must be available in a repeatable form and will normally be in either written or electronic form. 

There is great debate regarding the inclusion of operational safety within the scope of validation. In principle, there can be no question that safety of personnel is as critical if not more critical than product safety. With the advent of lEC 61508, there is no doubt that industry regulators, e.g., the U.S. Food and Drug Administration (FDA) and UK Medicines Control Agency (MCA), are interested in demonstrable evidence of system quality and performance. 

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