Effective Auditing
Quality auditing is the cornerstone of many quality programs. Managers rely on it to verify that their own quality systems as well operations quality procedures are followed. For those that claim that auditing is as much an art as science, here are some pointers to improve your audits.
Know your standards thoroughly
All to often, auditors get complacent with the standards. Either they auditee does not know the standards well enough to challenge the auditor or the auditor just gets sloppy, be sure to review the actual text of the standard and the intent. If a finding cannot be traced back to its violation of the accepted standard, then it is just an opinion.
Develop an audit checklist
While there is a burgeoning industry in providing audit checklists to quality managers, nothing is quite as useful as a custom checklist using a company's actual procedures, forms, and standards. They reduce the time it takes to audit, leads to better findings, and a more comprehensive assessment. It goes without saying that if one is not using a checklist, then that is even worse.
Use a combination of interviews, observations, and written records to compile evidence
Auditing cannot be completed in a conference room or walking around the manufacturing floor looking for findings. Good auditing is a combination of procedure review, physically observing behaviors, and reviewing written records. For example, if a procedure states that the process uses a specific piece of calibrated instrumentation, the auditor should get up, go out to the floor, and verify that the instrument is in use.
Get two pieces of evidence before issuing a finding
Since auditors are not experts (although seem to think so), there is always a chance of making a mistake when compiling findings. Always get two pieces of evidence before saying that something is a finding. For example, if the auditor suspects the corrective actions are not being completed in a timely manner, review the records until two or three are found. This way the auditee cannot claim that is was just a fluke, and the auditor was just "lucky".
Compile several small findings into system failures
Always be on the lookout for systems failures. When the findings are piling up in an area, try to understand the ultimate system failure. For example, if one finds that a validation protocol was unapproved, validation conditions were not met, and that some processes were not validated, this is really one system failure (validation) and not three small instances.
Never provide guidance, feedback, or suggestions for improvement
No matter how much they beg, no matter how much they whine, never, never, never tell an auditee how to correct a finding. It is not the responsibility of the auditor to manage the auditee's firm. By making comments, suggestions, or providing feedback, the auditor is taking on ownership of the problem and consulting with the organization. This removes auditor independence in now he or she is auditing systems that they helped design. If auditees need help with addressing corrective actions, then this should be done outside of the audit by another independent party.