Quality Control Records

A few years ago, a customer filed suit against a nationally known manufacturer of automotive brake fluid for supplying faulty merchandise. When the company s control chemist went before the jury with his detailed quality control records, he was able to prove that the allegedly faulty batch made two years earlier met all the requirements established for this product. The plaintiff lost his case. 

Quality Control Records. Accurate quality control records are of utmost importance and may be required by law, as in the pharmaceutical industry. A few years ago, mandatory Good Manufacturing Practices were proposed for the cosmetic industry. Although the proposal was later dropped, many manufacturers go by the rules worked out at that time for laboratory testing and record keeping. The food industry also requires extensive testing and record keeping. 

Inspections by owner include inspections, verifications, and audits of the construction of piping systems, which include fabrication, welding, heat treatment, assembly, erection, examination, and testing, in addition to the construction organization s documented procedures, personnel qualifications, and quality control records. 

The quality control program must clearly define goals for monitoring performance, procedures, policies, tolerance limits, corrective action, and related information. Records must be maintained regarding the reactivity of controls on a daily basis, along with an ongoing mechanism to evaluate the corrective actions taken when a control is unacceptable. These quality control records must be maintained for 2 yr. 

Raw material quality control records Retained sample documentation Quality control (qc) lab logs Emergency responder logs... 

The management system is owned by and is the responsibility of the top management, ft is incumbent on the management to review the overall effectiveness and currency of the system and the range of services offered by the laboratory. This should be done annually, and should include input from internal audits, clients, staff, and quality control records. The review should also consider supplier performance, wider management issues, and any changes that have affected the laboratory. The review should be used to... 

Once the business processes have been agreed, a GxP assessment can be conducted. This should address those operational aspects of the system that impact the quality of finished pharmaceutical products and will include supplier details, batch records, laboratory quality control records, batch release, and recall. An example of a GxP impacting functionality in an MRP 11 system is given in Appendix 35F. Experience suggests that perhaps between 25 to 50% of MRP 11 functionality is GxP critical. The GxP operational aspects will form a focal point during any GxP regulatory... 

Under current U.S. federal guidelines, the following records must be retained for at least 2 years for all laboratory testing specimen requisitions, patient test results and reports, instrument printouts, accession records, quality control records, instrument maintenance records, proficiency testing records, and quality improvement records. Laws concerning records for paternity and forensic testing vary by state it is the responsibility of the director to assure all applicable regulations are met. 

The personnel, premises, and equipment in the laboratories should be appropriate to the tasks imposed by the nature and the scale of the manufacturing operations. The use of outside laboratories, in conformity with the principles detailed in Chapter 7, Contract Analysis, can be accepted for particular reasons, but this should be stated in the Quality Control records. 

Quality Control Records of tests on starting materials, packaging materials, intermediate and bulk products and finished products should include ... 

All returned good, regardless of reason, shall be impounded to prevent integration with other material. No such material shall be released without approval by Quality Control. Records shall be maintained of quantity and date received and actual disposition of the product. 

Detector quality control records are reviewed to assure that control samples and the radiation background have been measured recently and that the detectors in use are within control limits (Section 11.2.10). Brief control source and background measurements are performed before the screening process begins to assure that detectors continue to operate appropriately and have not been contaminated recently. The detection limit in terms of activity per sample is calculated for all radionuclides of interest to determine whether a null result will meet radionuclide detection requirements for the submitted samples. 

The last step before release of the finished preparation is an overall check of the preparation and quality control record of the product. In order to be able to release the preparation, the person responsible for preparation has to check if the BPR has been fully completed. His review should comprise a systematical check on all data, including correct weighings and measurements, in process controls, notes and deviations, if any, and the presence of printed informatimi such as weighing prints or data on a sterilisation process. Also the results of non-destructive and analytical testing are part of the review, if applicable. Furthermore, the review should involve a check on obvious mistakes, for example a yield that shows a large deviation from the theoretical yield or a... 

One of the most powerful weapons any manufacturer trying to steer clear of product liability suits can have is a comprehensive testing and recordkeeping program. In many cases, quality control records may be the only defense the manufacturer may have in a courtroom. 

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