Audits customers, identifying

QA should audit at least the most important suppHers. This type of review often results in the exchange of ideas for improvement to quaUty systems of both the suppHer and the customer. Sometimes such an audit also identifies a suppHer having a serious deficiency. 

You need an improvement system that causes improvement opportunities to be identified. Relying on chance encounters will not create the conditions needed for continuous improvement. The data that needs to be analyzed will be generated by a particular process and this process governed by particular documented procedures. By having already placed instructions in these procedures for certain data to be transmitted to your data analysts, you can cause opportunities to be identified. Other opportunities that are less dependent on product or process data may arise from the audit process and particular projects such as benchmarking, customer and supplier surveys. 

In order to identify the success factors for custom manufacturing, an antagonistic approach is recommended the selection criteria for outsourcing partners, as established by a major pharmaceutical company, are listed in Appendix A.6. Those fine-chemical companies, which best comply with the 28 criteria, obviously have the best chance to become suppliers. The ranking is typically based on an extensive audit of the prospective supplier. 

Before starting an on-site audit, plan the audit. Review past audits, note indications of possible problem areas and items, if any, that were identified for corrective action in a previous audit. If you are not already familiar with this facility, learn the type of product produced and how it is organized by personnel and function. What does your customer, that is, your superior or senior facility management, expect to learn from this audit ... 

This safety audit is used for identifying inputs and material flows, processes and intermediates, and final products - but with special attention paid to human-material/process/equipment interactions that could result in (a) sudden and accidental releases/spills, (b) mechanical failure-based injuries, and (c) physical injuries - cuts, abrasions, and so on, as well as ergonomic hazards. Additional sources of adverse effects/safety problem areas are records/ knowledge of in-plant accidents/near misses, equipment failures, customer complaints, inadequate secondary prevention/safety procedures and equipment (including components that can be rendered non-operable upon unanticipated events), and inadequacies in suppliers of material and equipment or maintenance services. 

External audits of raw material suppliers and contracted services should be handled in much the same way as the internal QAP. Audit protocols should be customized and tailored to the specific organization to be audited. For example, an assessment of a contract laboratory service should be conducted under the auspices of the internal audit team and follow similar procedures in terms of identifying deficiencies, installing corrective and preventative measures, and reports issuing. It is an advantage to employ the same personnel for both the internal and external audits. This approach assures a standardized and uniform audit procedure across the board. 

Audits are conducted as a management tool for assessing the quality level of an operation. They are used to identify nonconformance and to make corrective actions as needed, and prevent reoccurrence of potentiail problems that can adversely affect a product. Audits are conducted internally and externally. Supplier audits may be directed for cause , such as a customer complaint, for change control, or for a product problem. Audits may be scheduled on a regular basis (e.g., every 3 years) for suppliers of key or critical materials. 

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