Quality systems document control

A note in clause 4.2.1 states that all the quality systems documents should be controlled. 

The standard doesn t require a procedure for Management Review and while it does require procedures for Design Control it does not specify that a Design Review Procedure is required. The phrases consistent with and in accordance with have the same meaning as both imply compatibility and agreement. If you restrict yourself to a literal interpretation of the standard, you need produce no more than 43 documented procedures - possibly less if some aspects do not apply to your business. You can combine several procedures in one document, the size of which depends on the complexity of your business. The more complex the business the greater the number of quality system documents. The more variations in the ways that work is executed, the larger the quality system will need to be. If you have a small business and only one way of carry-... 

Document and data control is one of the most important aspects of the quality system. Although not the only aspect of the quality system, documentation is the foundation stone. The requirements for document and data control can be confusing because the standard doesn t specify what a document is and whether a record is a document or whether data are documents. As data is information and documents are recorded information perhaps this clause should have been headed Information control. There is often confusion also between quality system documents and quality documents and between technical documents and quality documents. There is no doubt that all documents, data, and records should be controlled but the types of control will vary depending on the type of document. 

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 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 OPCW has created the following quality system documents to control the proficiency testing. The documents are Standard Operating Procedure for the Organization of OPCW Proficiency Tests (QDOC/LAB/SOP/PT1), Work Instruction for the Preparation of Test Samples for OPCW Proficiency Tests (QDOC/LAB/WI/PT2), and Work Instruction for the Evaluation of the Results of OPCW Proficiency Tests (QDOC/LAB/WI/PT3). 

The excipient manufacturer should have a system to control all documents and data that relate to the requirements of the quality system. Documents and subsequent changes to the documents should be reviewed and approved by designated personnel before issuance to the appropriate areas identified in the documents. A record should be kept of where the controlled documents are located. The control should assure the issuance and removal of the appropriate document to the areas previously identified. 

To determine the procedures you need you should design the system from the top down. Some requirements will apply to many operations such as document control, corrective action, and quality records whereas other requirements may apply to only one operation, such as auditing and management review. A matrix showing this relationship is given in Appendix D. 

Documents and data that relate to the requirements of the standard could be interpreted as including all the documents and data you produce, or be limited to those documents that are essential to the achievement and demonstration of quality. The requirement can be quite onerous because it requires that every document has an associated governing procedure. So if you include memoranda in your system, you will need a procedure to control them. The way out of this maze is to use the quality system to define the documents that need to be controlled. 

Ensure your quality system procedures identify all the types of document requiring control including external documents. 

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. 

Quality Management system priorities to consider are management responsibility, quality system principles, auditing, contract review, design control, corrective action, document control, quality records, training, product safety and liability, and statistical techniques, because these are critical aspects of the Quality Management system where Xmple Inc. already has some systems in place. 

Documentation is at the core of all quality systems, and was discussed in Chapter 2. Examples of the types of documentation associated with pharmaceutical production are shown in Figure 11.9. European regulations require that records which permit tracing of the full history for each batch of product should be retained for 1 year after expiry of the product or 5 years, whichever is the longer. US regulations require the retention of records for 1 year after batch expiry or 3 years after the last distribution in cases of some OTC products where no expiry date is assigned. Additionally, the US regulations require the preparation of a Master Production and Control Record ,... 

As has already been mentioned in Chapter 2, ISO 9001, Management Systems - Requirements , is increasingly being adopted by laboratories to cover the aspects of their business that are not laboratory based. This is because this Standard is more about controlling the process and service enhancement rather than technical issues. It requires continuous improvement, demonstrating that quality is not a static process. The requirements for such matters as documentation, document control, purchasing and management responsibilities are much the... 

The major category of nonconforming work is allocated for any failure of a system to comply with the requirements of the Standard which could lead to invalidity of test results. Examples include absence/non-implementation of a document control system, absence/non-implementation of a procedure for internal audit or management review, staff not technically competent to perform particular tests and failure to control the quality of test data. 

Quality control examinations shall include the requirements of the construction organization s Quality System Program for materials, products, components, workmanship, quality documents, procedures and personnel qualifications, construction, and subcontract services. 

Each construction organization shall be responsible for developing a QSP. The Quality System shall include a quality manual, quality policy and objective, structure of organization, documented procedures, work instructions, a quality plan, and document and data control. 

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. 

The guidelines also stress that the perfunctory execution of any quality system will not guarantee the production of data of adequate quality. The correct procedures for feedback, remedial action and staff motivation must also be documented and acted upon. In other words, there must be a genuine commitment to quality within a laboratory for an internal quality control programme to succeed, i.e. the IQC must be part of a complete quality management system. 

The production of the API and finished dosage form is required to comply with GMP regulations discussed in Chapter 9 and Section 10.2. The quality system, quality control, and validation of equipment and processes have to be developed and adhered to in the manufacturing process. Proper records and documentation are required to be kept in the forms of batch records. 

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