Writing Audit Observations Part-II

Audits are generally a social exercise where the auditor represents the human face of his/her Company to the auditee. As such, auditors act as a sort of ambassador, not only for quality but also for his/her company itself. Therefore, through an auditor’s professionalism and “soft-skills,” the auditor is given the opportunity to influence the auditee in his/her Companies own interpretations of the quality standards as well as Companies expectations of quality. In this particular article I tried to give few ideas/ suggestions regarding writing the observation & recommendations in the final audit report.

The audit report provides an objective description of the states of compliance and control with respect to the Audit Scope found at the time of the audit. An audit is a sampling, not a detailed inspection or investigation. The purpose of the audit report’s observations section is to list observations and findings that have the potential to impact the safety, identity, strength, efficacy, quality, or purity of the Scope product.

duct. It may be helpful to distinguish here between the meaning of “findings” and “observations.” A “finding” is a quality concern that may be described as the “observed systemic failure” whereas “Observations,” on the other hand, are those objective noncompliance examples seen during the audit that give credence to the quality concern claim being made in the finding. For example, “Ensure that sampling practices do not have the potential to contaminate product (i.e., the finding). For example, it was observed that sampling scoops were being stored in direct contact with exterior surfaces of production equipment and there was no procedural requirement to do otherwise” (i.e., the supporting observations). Observations must be a clear violation of the audit standard(s). That is, the auditor may observe practices that would be clear GMP/GLP violations at an API or pharmaceutical finished dosage form facility but the same practices are not necessarily GMP violations in other industries. Put another way, the quality assurance/control practices found at a commodity chemical manufacturer following ISO 9001 are different from the quality assurance/control practices found at a API/ finished pharmaceutical plant following GMP.

Both plants have controls to assure the quality of their products but the degree of assurance is different. Auditors must respect these differences, not expecting more than the usual and customary requirement for the industry being audited. For example, second person verification of most laboratory calculations as well as the manual entry of analytical results into a LIMS is expected for API and finished dosage form manufacturing plants; however, there is no such requirement in plants operating to excipient GMP or ISO 9001 quality management systems (Packing material manufacturer)

In general, reported observations should be grouped together into related findings. However, a balance should be made between reporting all observations in a single finding and reporting all observations as individual findings. For example, it would be inappropriate to have a single.