Background of the interviewee
- Received a Bachelor’s degree in Chemistry, and a Master’s degree in Food Science with a minor in Food
Microbiology. He has worked in the environmental field as well as in food laboratory environments, and
now serves as Senior Director of Quality Assurance and Technical Services for a major U.S. food processing company. He says his job is very rewarding, because it is, in his words,
“a pragmatic application of science.” It was what the industries practice so i think it is quite useful to read it.
He actually talked about product recall which i think it could increase our understanding towards recalling procedures based on pragmatism from this particular article. Some of the interesting questions were extracted out from the interview based on his experience.
Q: How do food recall situations usually start, in your experience?
A: The classic way that it starts is from a complaint from our consumer hotline. The initial complaint
often doesn’t give us enough information. Then we’ll get a second complaint, or a third—and you see a
pattern. Then you start digging and doing your research right away, whether the complaints pinpoint a
plant or a line or a process. You’re trying to find out when it happened, exactly what happened and
where—to put some boundaries around it.
Q: What are the biggest and smallest recalls you’ve been involved in?
A: The smallest probably involved, maybe, 15 cases. It was an *allergen labeling problem. The largest was
probably 31,000 cases. The problem there was *foreign material.
*I was thinking whether the causes of recalling could still be allergen and foreign material even if these two companies have proper labeling and GMP practices...
Q: What in the world makes the difference between a 15-case and a 31,000-case recall?
A: It’s the scope. You do your investigation and go back through your records and decide what happened
when. The 15-case one was pretty easy. The record showed the film (printed bags) was put on the line,
it was the wrong film, and they took it off the line. The product was put on hold, but a partial pallet got
released. It was a simple gap in the production process.
In the other one, the foreign material looked like it was shed on the production line, over a given
period of time. What you always try to do with foreign material is determine whether it’s an isolated
incident, or something that was systemic. When your raw materials are crops dug out of the ground,
you’ve got foreign stuff coming into the plants all the time. We have procedures for containing it, shutting a line down, isolating the problem and cleaning it up. So when you get a complaint about a foreign
object, you have to decide if it came in with the raw material, or if it’s something that shows a systematic failure of a piece of equipment on the line, like a shard of metal.
Q: What’s it like working with the FDA?
A: I’ve found them very good to work with. They generally want to do what’s right and want to be pragmatic. They’re fairly rigid in what they expect. They have their own internal protocol in terms of how
decisions are made—like how to classify a recall as I, II or III—so the person you’re working with in the
field may not be the person who’s making the decision, and sometimes that’s frustrating.
Recalls are voluntary, so they really can’t force us to do one, or can’t come in and just take control.
What they will do, is ask all sorts of very specific questions and expect you provide them the information, rather than showing up and your plant and saying, ‘We’re going to investigate.’ They WILL come
into your facility after a recall, to inspect and decide if they feel comfortable with the safety of the products coming out of there. Most of the flurry of activity is in the containment phase, which has to be
done very quickly, within a day or two. The follow-up and verification is done over weeks, and months.
On a Class I recall, it may be a year before it’s totally done.
Q: But overall, will people survive a recall?
A: Maybe. You have to keep impeccable records, and you have to keep them for 3 to 5 years. They won’t
survive if they don’t have good records. I guess it was for the cases which would develop the disease after period of time but not immediately just like BSE.
By Yueming
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