Put together an Inspection Team that will be responsible for dealing with the inspection when the FDA is on the premises. The inspection team should consist of:
Responsible Person — Select a high-level officer or manager, someone with ultimate responsibility for the company’s compliance. This person could be as high level as the CEO or COO / PRESIDENT. In some instances, someone like a General Manager might be appropriate.
Inspection Escort — Select a management level employee (e.g., Quality Head or General Manager, Operations Manager) who is familiar with the everyday operations of the company. He or she needs to be a good tour guide, know where everything is, and be able to answer general questions about the day-to-day operations in the facility.
Subject Matter Experts — Select team members who are knowledgeable and competent enough to answer very specific questions that the FDA may have. For example, these questions may address intake of products, raw materials; manufacturing/GMPs; hazard analysis and preventative controls; distribution; product traceability/recalls, and labeling. These SMEs most likely would not be with the inspector throughout the duration of the inspection, but rather would be available when needed for specific questions.
Record-keepers — It’s important to identify important document categories beforehand, particularly those that track closely with topics for the SMEs. Ordinarily, record-keepers will not have direct contact with the FDA, unless this person is also serving another Inspection Team role.
Audit Facilitation Audit : General Rules
- Work stations/ desks are neat, clean & tidy.
- Noise levels in the office/bathrooms/canteen/stairwell etc. and especially around the room where the audit is taking place.
- Inspector may "tour" the office building. Ensure employees are aware of this.
- Know what other visitors will be on site on the day so there are no surprises.
- Keep visitors car parking space free/ reserved and be ready for the auditors arrival.
- Have a designated “War Room” and “Runner” for expected audit documents.
- Assign a lead audit facilitator (lead SME) as a focal point for the auditor.
- Have Subject Matter Experts (SMEs) available to answer
DO's
- Be Prepared
- Be Courteous and Polite
- Be Prompt and Professional
- Be Cooperative with colleagues
- Be Confident and Positive
- Consult procedures, notes, documentation and resources as needed
- Listen attentively to the question asked
- Answer only for the Question Asked
- Ask for clarification if you do not understand the question
Don’t
- Don’t take anything personally – Auditing is not criticizing
- Don’t Leave the auditor on their own for long periods of time
- Don’t Be Argumentative or Overly Opinionated
- Don’t Be Rude
- Don’t Be Anxious to please
- Don’t Be Gullible
- Don’t Be Easily Diverted/Distracted
Read also: Understanding the 4 Types of FDA Inspections
Resource Person: Chakrapani K V C
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