By Dr. Ajay Shah
Typically, the week before an audit, quality assurance (QA) personnel will inspect the plant to prepare for the auditor’s visit. Hazard Analysis and Critical Control Point (HACCP) plans are reviewed, records are checked for signatures and dates, and the corrective action log and other documents are brought up to date.
Some training may be undertaken to ensure employees can answer audit questions correctly on the day of the audit. The night before the audit, QA will work with operations to ensure the plant has a thorough cleaning. Just before the auditor arrives, a final pre-audit audit is completed to ensure the plant looks good visually. Experienced QA personnel know exactly what to do to ensure the plant receives a good audit score for that snapshot in time for the auditor’s visit.
An audit’s true function is to provide the client with an accurate and detailed picture of the plant’s performance. The client wants to know what is really happening in the plant day after day, and whether actions need to be taken to improve performance. The key is to have processes in place to allow the auditor to understand how the organization’s food safety management system works. In addition, the audit process needs to assess if critical processes are not present or if critical procedures are weak.
A process audit is conducted by reviewing procedures and documents, and asking questions of individuals directly involved with the process who perform work that is linked to the process. Next, the auditor determines if the responses are consistent and in alignment with documented policies, objectives, procedures, and records. If the responses are consistent, this is evidence that the system is functioning properly. If the responses are inconsistent, then the auditor will have to continue to search to determine the reason why this is the case and to collect evidence which supports the inconsistency. This is known as creating and following audit trails. The auditor seeks to find the reason for the inconsistency and then link it back to the management system and a standard, so that the supplier can identify and address the inconsistency.
When open-ended questions are asked and audit trails are followed, it is very difficult for a supplier to distract an auditor away from the execution of a thorough, in-depth audit with artificially “sanitized” answers. The only way to prepare for this type of audit is to do the right thing day after day. Most of the time, employees are willing to tell you what they do, even if they are not doing their job correctly at the time of inspection. In addition, by investigating the linkages, one can determine if the processes are operating in a manner that is consistent with stated policies and objectives.
The process audit is a powerful tool. It allows the auditor to go beyond inspecting the cosmetic issues in a plant. The process audit is designed to understand how the plant functions day to day. Cosmetic issues, such as determining if HACCP plans are signed and up to date are still audited. However, these issues become part of the audit, and are not the primary focus. When an auditor sees a potential finding on a cosmetic issue, this sends a signal to the auditor. The auditor responds by digging deeper into the process and other supporting processes. This technique forms an audit trail that allows the auditor to determine whether the organization’s system is effective to manufacture safe food. The audit report then becomes a record of the supplier’s performance on that day with an added indication of how that supplier operates on a daily basis.
Some things to note when conducting a site visit include psychologically analyzing staff behavior and checking the training of the staff that you have interviewed to ensure that they have been trained appropriately for the job. One can also look for inconsistencies on records to ensure that the records have not been fabricated in any way by checking for any inconsistencies.
Finally, there are some fundamental policies that should be developed with regard to the auditor conducting the actual inspection which includes:
- Have an open mind
- Determine the area to be inspected
- Observe employee/in-plant practices
- Record defects noted
- Look at obscure places
- Be constructive, watch details
- Be complete, specific and brief
- Distribute, so immediate action can be taken
- Compliment/recognize good work
About the author
Dr. Ajay Shah is a highly experienced food scientist/technologist trained in the United Kingdom and draws from impressive academic achievements and career highlights both in Australia and abroad.
He is a registered food safety auditor, and an auditor for Cosmetics – Good Manufacturing Practices and Corporate Social Responsibility. He is also technical manager for ISO 22000:2005 and HACCP for one of the certification bodies. Shah has lectured in food science and technology in Australia, the United Kingdom, and New Zealand, and has reviewed food science and technology publications for the Australian Institute of Food Science & Technology and the Institute of Food Science & Technology (UK).
Shah operates a food technical consultancy business that provides scientific and technical food solutions including organic certification from organic certifying bodies for food industries.