A lot of time and effort is put into auditing. You want to make sure that your audits are giving you the best information possible.
Some common problems with audits include:
- Audits that just skim the surface and don’t dig in deeply enough to uncover potential issues.
- Auditors that ask the same questions every year. Typically these audits are run with a checklist that is never updated and additional questions are not asked.
- Audits that only include auditees from the laboratory and does not look at other areas that have responsibilities in the Quality System such as upper management, IT, Purchasing, etc.
Take a look at the list some audit best practices below and see which ones you are using in your internal audits.
- If using audit checklists, coach the audit team on the expectation that they will add their own questions to the interviews, based on document reviews.
- Ask auditors to provide details on which parts of the test methods or other procedures they audited. For example, if they could only audit the first half of the procedure due to time constraints, you can ask next year’s auditor to audit the second half.
- Do a thorough audit of a few test methods and other procedures every year. Track which procedures get a thorough audit each year and cycle through all your procedures in subsequent audits.
- Where possible, your auditors should be independent of the area being audited. This includes the audit of your management processes. The Quality Manager should not be auditing their own processes and procedures.
- Have your audit team do a debrief session after every audit. They should look at what went well in the audit and what could be improved. The team should document recommendations on what can be done to improve future audits.
- Provide your auditors with feedback on their auditing skills. The Quality Manager, Lead Auditor or another qualified person should observe the audit interviews and review findings. Give feedback on both the areas being done well and skills that need to be improved.
- If your organization does performance evaluations include auditing as one of the outcomes for auditors. Provide the auditor’s manager with feedback on the auditor’s performance on the audit to include in the evaluation.
- Expect auditors to audit beyond the laboratory floor. If they are auditing a procedure where upper management or another department has responsibilities, facilitate audit interviews with those areas.
- Periodically include a check on items such as method validation, and comparing laboratory version of the method to the standard method.
- Coach your auditors on how the testing methods fit into the overall quality system. The better the auditors understand the full quality system, the more thoroughly they will be able to conduct an audit.
- Encourage your auditors to observe testing methods in addition to interviewing the analysts.
- If feasible, bring in internal auditors from another lab, and send your auditors out. Fresh eyes on the laboratory’s processes will give you a new perspective on your quality system.
- Provide training to your auditors, including the opportunity to upgrade their skills.
If there are items on this list you have not included in your audit, consider implementing some of them on your audit.
If you need to train your auditors, CALA provides two courses – Internal Auditor for ISO/IEC 17025 and Lead Auditor for ISO/IEC 17205.
CALA Training also has some webinar recordings on auditing skills, including Skill Sharpening for Internal Auditors, and The Top 12 Questions to Ask During an Internal Audit.
Click on the Courses or Webinar menus to check out the CALA Training options.