As important as it is to build a program that works, it’s equally important to build a team of qualified auditors capable of ensuring your programs are thoroughly evaluated and meeting required expectations before your certification auditor arrives.
You want to pick your most qualified personnel to be on the internal audit team. Your internal audit program will have requirements established for your auditors. There is a definite need to have documented training for qualified auditors. For example, if you expect an auditor to review a HACCP plan then that person would have to receive training in those program requirements. If auditing a laboratory, then that person should have job experience working in a lab or have knowledge of the Good Laboratory Practices or a similar program. The same could be said for someone auditing the sanitation or maintenance departments for the activities they perform. Ideally, all internal auditors should receive training on HACCP, prerequisite programs, and the specific industry scheme your facility is certified for.
Your auditors must have sufficient knowledge in the activity they are auditing. If they don’t have adequate knowledge of the process a team leader should assist them or shadow the audit until they have developed skills to audit independently. It takes time to develop a qualified auditor that is fully competent to effectively complete an audit.
As auditors gain ability and confidence in their skills they’ll learn what you need to see to evaluate an activity for effective implementation. There will be conformance and non-compliance, but it is important to keep the auditee informed when significant issues are observed. Be prepared to note significant deficiencies that could be a regulatory issue. If significant issues are uncovered they should be communicated immediately to upper level management. Internal audits can uncover contamination such as infestation, undeclared allergens, and the unsanitary conditions. These are all significant issues that must be corrected immediately and properly communicated to management.
There are several auditing techniques that should be used during an internal audit to ensure that all non-conformances and potential contamination issues are identified.
One technique that auditors use to uncover further issues in the activity being reviewed is an audit trail. For example, if a contractor is observed not following the GMPs during an audit of the warehouse’s receiving, storage, and temperature control requirements, you’ll have to follow-up to investigate why this person was able to get into the warehouse unaccompanied and without proper GMP attire. This technique is similar to root cause investigation in that you keep asking why something occurred until you get to the end of the line. In many cases the issues noted when doing audit trails can eventually be traced to ineffective training of company personnel.
Asking good questions that require an explanation such as, “Can you explain how you set up and run the CIP system to clean this filler?” helps to evaluate if personnel understand their duties. Yes and No response questions should not be used very often as they do not require an explanation and usually do not convey the necessary information being audited.
Another auditing technique is to complete the audit like a flow diagram, which is a process approach. It is sometimes referred to as a straight line audit and is useful in the sense that you will not miss any part of the operation. It can also be used in the reverse application where you start at shipping and work your way backward in the process. This technique is often used when doing milling operations that have a final packaging area and much of the process is enclosed in equipment and pneumatic systems.
Some auditors use systematic questioning to stay on track and focus on the activity being audited. For example, ask the auditee to explain the activity they perform, ask them to perform the activity, and review the records they are required to fill out. It may sound simplistic but it is important to stay focused on the activity being reviewed.
Interviews are an excellent way to gauge if personnel truly understand the activities they are performing. Asking them to verbally explain what they are doing allows you to get a feel for the organization in that they understand the importance of their job and how they accomplish it.
Observations are necessary to confirm that activities are being performed as planned and that proper sanitary practices are in place. Internal auditor observation skills will improve with each audits completed, allowing less obvious deficiencies.