2.7: Inspection, Audit, and Surveillance

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Inspection, audit, and surveillance are three tasks conducted in the quality effort that may cause some confusion to a newcomer in quality. Similar in some ways, and unique in others, each has a different purpose.

Inspection

Various inspections are best used to gather data for a proactive approach to problem-solving. Not only should the inspection be used to identify a nonconforming product, but it should also collect the data needed to determine the root cause of the problem and to find and monitor the remedy.

An inspection may involve:

Receiving inspection: Ensures items received from vendors meet order requirements
Source inspection: Review the vendor facilities to ensure quality standards
In-process inspection: Ensures quality during fabrication or assembly
Final inspection: Verify all steps were correctly performed, quality of materials were used, final tests were coordinated with the customer, inspect spare parts, and check shipping containers to assure safe delivery of a product

Audit

An Audit is an inspection of an organization's adherence to the established quality standards. In a small start-up company, it may be possible for one person to perform or at least supervise all the aspects necessary for the production and testing of a product. As the operation grows, however, it is no longer likely that a single individual is knowledgeable in all functions or confident of the level of quality employed during all operations. Therefore, systems must be set up for the accumulation of data and for the review of that data. Also, the systems themselves must be examined or audited to determine that they are still operating as originally planned.

A company can do an internal audit (by people from the company itself) or hire an external auditor (people from outside the company) to make sure that they are following established quality standards. In some cases, an external agency, such as the Food and Drug and Administration (FDA), could audit a biotechnology company to ensure that they are following current good manufacturing practices (CGMPs).

The quality audit should be designed to answer three basic questions about the organization being audited:

Quality System: Does the organization have a quality system? This is usually evidenced by a quality manual, operating manual, or quality procedures.
Adherence: Is the quality system being followed? An audit is conducted to determine whether the procedures are adhered to on an ongoing, consistent basis.
Effectiveness: Is the system effective? Are the results of following the procedures consistent and positive?

The auditor does not carry the authority to make corrections in the procedures, so the results of the audit are given to upper-level management for further action. However, the auditor will follow up on findings and recommendations to ensure the recommended changes have been implemented. In the case of a regulated industry, the process and frequency of a quality audit may be defined by the regulating agency. In this case, the audit program of the industry is often subject to inspection by the regulatory agency. For example, an industry regulated by the U.S. Food and Drug Administration (FDA) must provide access to an FDA inspector to its audit procedures. The manufacturer may be asked to provide evidence that its audit program is functioning, is well-documented, and is instituting corrective measures when appropriate. A certification by an outside auditor or access to an internal audit log (or history) may be used to demonstrate that the system complies.

Surveillance

Surveillance is an alternate inspection process that uses some of the techniques of both the audit and inspection functions, although less precise than either of the two. Most commonly, surveillance is an objective evaluation to determine how well the quality procedures are being followed in day-to-day production, along with determining how well the procedures, when followed, maintain the quality of the product.

Surveillance answers the questions,

Is the process of performing as planned?
Is the product of acceptable quality?
Have the recommendations of the audit been incorporated?