Frequently Asked Questions about EHA's Food Safety Services
What exactly is an inspection or an audit?
Health and safety regulators, inspectors or 3rd party auditors may conduct an inspection or "audit" of your operation for a variety of reasons. These include routinely scheduled inspections or audits, unannounced inspections or audit, agency responses to a reported problem or audits requested from your customer base or the end user. Some audits may be related to work conditions or staffing.
For the purpose of this discussion, we will limit the content to inspections and audits performed to evaluate and protect the general public (consumers) against the risks of foodborne illness or contamination from biological, chemical or physical sources. This includes manufacturing, handling, processing, warehousing and transportation of foodstuffs and related materials, characterized as both edible and non-comestible (inedible), but all for use in and by the food industry.
How is the process initiated?
The inspector or auditor may or may not contact you in advance to schedule the visit. This is dependent on a number of factors with which you usually have limited control. Upon arrival, the inspector must present credentials and either an "FDA Notice of Inspection Form 482" or similar document (if a government inspector) or, if an independent inspection agency, or a letterhead document summarizing and explaining the objectives and expectations of the visit.
A knowledgeable person in your firm, such as the plant, Operations or Quality manager (representatives and alternates should be in advance for this expressed purpose), should accompany the investigator or inspector at all times. It is clearly in the best interests of your Company to fully understand the agency, the purpose of the inspection and all procedures and expectations. When you are unsure of certain questions, actions, or the intent of the investigator or auditor, don't hesitate to ask questions.
What are the various steps in the process?
Usually, the individual or Team will proceed as follows:
- Introduce him/herself again, state the name of the inspection agency/firm and give a summary overview explaining who requested the audit/inspection and it's purposes.
- Ask a series of basic or boilerplated questions relating to your Company and the specific facility being inspected (description of operations and products, number of employees, square footage, etc.) They may ask you what represents the highest risk (in your opinion) to safety and quality.
- Visually examine your production facility, processes and related supports.
- Request, evaluate and ask specific questions about aspects of records, documents, procedures, programs and methods.
- On a limited basis, collect samples or take "swabs" using standard microbiology collection devices (typically limited to regulatory agencies such as FDA, USDA, State or local authorities, but not always).
- Revisit related areas previously discussed, seeming at times to ask questions or discuss areas that have already been addressed
What happens after the inspector or auditor has completed the inspection?
At the conclusion of the inspection or audit, the investigator or auditor will meet with designated management. It is required that the plant manager or his/her alternate attend this meeting along with the managers of Quality and Operations or Production. The auditor/inspector will then summarize the visit objectives and discuss with Management any significant findings and concerns. In the event that the visit is a graded audit, the auditor will identify areas of deficiency or excellence, quantify the grade or rating given and explain the rationale for same.
At this time, you are encouraged to ask any questions for clarification or understanding and then advise the inspector or auditor if you believe that any mitigating documents or evidence exists which could alter or impact the findings. In fact, corrective actions or procedural changes that were accomplished immediately in the presence of the inspector/auditor may be documented in the final report and are typically regarded as positive indications of your concern and desire to voluntarily correct discrepancies.
Do I get a report summarizing or documenting the inspection?
If the visit is from a regulatory agency, the inspector will likely leave management a written report of any conditions or practices, which, in the investigator's judgment, indicate objectionable conditions, or practices. If the visit is an independent 3rd party audit, the auditor will invite you to take notes related to the summary discussion, often times providing you with a blank template of his/her audit summary form.
Whatever the format, this list of "Inspectional Observations," should be used by your firm's management as a guide for corrective action. Note that regulatory agencies will not typically recommend specific corrective measures, whereas independent 3rd party auditors will under most circumstances identify industry best practices and expectations.
Your firm can and should respond to the deficiencies in some positive manner with the inspector. Note that corrections, although always positive, "after the fact", will not improve the score of a graded audit, but, of course, they are value-added steps in the Quality and Safety Process. You can expect to get a final, formal, hard copy of the report by mail within 10 business days of completion of the audit/inspection.
What if I disagree with the findings or grade?
If you do not agree with the actions being taken by the Agency or the findings or grading by the auditor, you should contact Agency or Audit Firm management to discuss and seek some resolution that is agreeable to all.
Conclusions and observations
In conclusion, the inspection and audit process should not be looked at as a painful and adversarial process by management or the Quality department. Rather it is an opportunity to show off your firm's diligence of quality and commitment to food safety.
In the event of a finding of deficiency, food safety violation or unsafe condition, it should be viewed as a huge benefit that the inspector found the problem internally before it became an external issue, giving you the opportunity to correct the condition, limit the harm and send the right message to all that you are committed to making and keeping your facilities and processes SAFE!
Contact EHA Consulting Group today for more information about how we can assist your company.