An audit should have clear objectives about which conclusions can be made.
So, you should begin by deciding which of the many possible purposes your audit will serve.
For example, audits can be performed to:
- Verify the extent of conformity of the implementation of GMP, or part of it
- Assess the competence of the management system to ensure conformity with GMP requirements
- Evaluate the effectiveness of the management system in meeting its specific objectives
- Investigate an unusual event or incident to determine facts, recreate events, and/or determine causes
- Or recognize areas for potential improvement
What is Your Role
Given the purpose or purposes of the audit, you must decide what type of perspective to adopt:
- Judge
- Data Gatherer
- Consultant
- Or Salesman
For example:
If your purpose is to examine an incident, act strictly as a data gatherer and hold back your decision and any comments you might have until you are confident that you have obtained all the significant facts.
Judge
The judge assesses the significant facts and evaluates them to some standard. (e.g., regulations or inspection criteria). They then decide whether the items they are examining meets, exceeds, or falls short of the standard. A Judge must be fair and objective.
Data Gatherer
The data gatherer reviews the available information on a given subject and evaluates these to establish which are the most relevant to the purpose of the audit. A data gatherer must be objective and insightful.
Consultant
The consultant examines a situation in light of existing limitations, management objectives, available technology, and industry experience. They then propose a course of action that will attain the desired result. A consultant must be technically competent and creative.
Salesman
The salesman convince the auditee to believe the auditor’s analysis of the facts. He persuades the auditee that a particular course of action will produce a positive outcome for the auditee and/or the industry. A salesman must be conversant and dedicated.
