In my last post I talked about two different inspections. I hope these “tales” encouraged you (neither was as “bad” as the mills expected); I hope these “tales” inspired you (to be “ready” for your inspection). Are you ready? What have you done? Over the next few months, I will recap the requirements of the FSMA rule. I hope I can encourage and inspire you to get ready for your inspection. Instead of me telling you what you need to do, I want you to tell me what you have done…
The original CFD FSMA project helped you to “say what you do”, by writing Standard Operating Procedures, the focus was on Current Good Manufacturing Practice. In my training classes I highlighted some of the best practices I have seen various mills do to comply with CGMP’s. Over the past few years, I am confident you have come up with some great ideas.
Every two weeks, I will post the text of one CGMP. I hope you will use each 2-week period to focus on your compliance with this part of the rule. Read it and think about your compliance. What have you done, what do you need to do better than briefly share one or two ideas of ways you comply with this CGMP. Here is the schedule:
I will summarize responses (anomalously of course) in an update to each post.
- 2/28 507.14 Personnel
- 3/14 507.17 Plant and Grounds
- 3/28 507.19 Sanitation
- 4/11 507.20 Water Supply and Plumbing
- 4/25 507.22 Equipment and Utensils
- 5/09 507.25 Plant Operations
- 5/23 507.27 Holding and Distribution
507.14 Personnel – Management of the establishment must take reasonable measures and precautions to ensure that all persons working in direct contact with animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices as necessary to protect against the contamination of animal food (21 CFR 507.14(a)).
Persons working in direct contact with animal food may include employees, contractors, and visitors. Methods for conforming to hygienic practices and maintaining cleanliness include: maintaining adequate personal cleanliness; washing hands thoroughly in an adequate hand-washing facility as necessary and appropriate to protect against contamination; removing or securing jewelry and other objects that could fall into animal food, equipment, or containers; storing clothing and personal belongings in areas other than where animal food is exposed or where equipment or utensils are cleaned; and taking any other precautions necessary to protect against contamination of animal food, animal food contact surfaces, or animal food-packaging materials (21 CFR 507.14(b)).
CLICK HERE when you are ready to share…
I recently spoke with two feed mills that I have worked with in different capacities over the years. Each has recently had a FSMA inspection. Without divulging the identity of either mill I would like to summarize the key parts of each inspection:
#1 – FDA conducted this inspection just prior to the March 2020 COVID pause.
- Our FDA Investigator was very thorough. He first read through all our programs and then toured the Mill Operations.
- Next, he came back and started going through records to match up with what we said we were doing in our programs.
- He was very meticulous in matching up employee training records and what our CGMP program said we would train for.
- He then looked for records to see if the individual that was trained had filled out documentation according to our plan.
- He concentrated on our CGMPs and their supporting pre-requisite programs.
- He focused in detail on our pest control program. Looking for trending reports and recommendations by our pest control technician and our own internal walkthroughs. He did his own physical inspection and found no issues.
- He was also very interested in all training that was done by our company.
- He looked at “Sanitary Transportation”: training records, testing, and certificates of completion.
- He looked at our Hazard Analysis, Flowcharts, and Feed Safety Program and no deficiencies noted.
- “All in All… it was not a bad experience.”
#2 – PA Department of Agriculture conducted this inspection in December 2020 on behalf of the FDA. It was a combined inspection for VFD, non-licensed medicated feed and CGMP’s. It did not include Hazard Analysis and Preventive Controls.
- For the VFD inspection he selected 3 random orders and went over the paperwork in detail.
- For the non-licensed medicated feed inspection, he reviewed all our required medication logs.
- He had notes from a previous state inspection and went over the issues identified in that previous inspection to determine if recommendations were corrected.
- He asked a long list of questions about CGMP’s and took notes on my answers.
- He then toured the entire facility from top to bottom to confirm we are doing what we say we are doing.
- He focused on housekeeping and pest control. We do pest control ourselves and he was looking for records.
- He was very interested in any, and all logs we keep.
- He asked about training since we have had several new employees recently.
- Although it was not the purpose of this inspection, he asked if we had begun our Hazard Analysis and if we are working on our Feed Safety Plan. He indicated that the state has contracted with FDA for a very limited number of these inspections, but we can expect one in the next couple of years.
- He was here for about 4 ½ hours.
- “We have not received our report yet, but I feel it went better than I had anticipated”.
It is difficult to comment on the differences in the inspections because the purpose of each was different. There are similarities and for the most part they included all the elements that we were told to expect from an inspection. Both mills felt like the “educate while they regulate” was indeed what they were doing. They hope this information is helpful.