How do I write a hazard that occurs and the preventive control for it?
Hi everyone, I am pretty new PCQI person at the factory for baked product. I have couple questions, how do I write a hazard that occurs and the preventive control for it. And has anyone use FDA food safety builder tool. I have started one but my laptop decided to reboot and I lost my work on the builder, (I saved it before it happened) but it keeps giving me an error. Any suggestions? Thank you.
Have you taken a HACCP course? That's the best place to start
Otherwise, I use this decision tree (not for FDA)
https://www.inspecti...7674768_eng.pdf
Use the link and look for form 8-CCP decision tree
No, I have not taken the HACCP yet, just taken PCQI certification online training.
I am having a little hard time to collect documents to keep records.
I will check out the link you sent
Thank you for the answer.
Do you have a master registry of documents? In the beginning when you're learning, it's helpful to have a list
Document Name
Who's responsible for completing it
Frequency
Then you can tick things off as you get then and help you to see what's missing
This can be a huge job until you get your feet under you :)
Surely the OP's query is definitively answered in the PCQI (free) manual/worked example(s) ?. And training analogs.
The FDA food safety builder is helpful when you're new. I used it at the beginning but then switched to an excel document. The tool isn't as user friendly as it should be. And I worried about the program not working with all of my items saved on it. You can create an excel document based upon the example in the training.
For potential hazards - appendix 1: Potential hazards for foods and processes
Thanks everyone, I have tried to use FDA Food Safety Builder, in the middle of my work my laptop turned off, I was not able to open the food safety builder back up (even it was saved). It keeps giving errors. How do you do it on the excel? any suggestion for it?
Scampi, what are master registry of documents, what kind of list i should be making?
I have learned so much from my PCQI training but practicing them is the hard part for me, since it is my first job experience as a quality assurance specialist
Thank you everyone again,
The document registry should list ALL of the policies/programs the SOPS that relate to them and then the records used to monitor those programs --see my example below
Policy SOP Record
GMP GMP Training Training Record
GMP GMP Monitoring Daily GMP Monitoring
Onsite Visitors Visitor Sign In
I think it's good to aken a HACCP course that's the best place to start...otherwise you can take some guide from its related forum and links
Thanks Scampi, that is helpful. I will check them.
I am planning to take HACCP soon, thank you kdscha777
No, I have not taken the HACCP yet, just taken PCQI certification online training.
I am having a little hard time to collect documents to keep records.
I will check out the link you sent
Thank you for the answer.
Hi Kubramillier,
I am confused.
You mention having "taken" PCQI Certification.
I would have thought HACCP is the core topic of this.
@Scampi - is the "Preventive Control (PC)" implemented in the (CFIA) tree/manual linked in Post 2 the same "PC" as within FSMA ?. Offhand, the definition looks different and it's usage in the CFIA "tree" is to my mind almost unintelligible? (eg what the heck is "partial control" ?)
Charles - they are similar. - see page 4. A Food Safety Plan is in essence a HACCP plan with more requirements/considerations.
Charles, come on! You know that some hazards have more than 1 control!
Let's see
Poultry slaughter example
I have VERY LITTLE control over what the animals are fed.............
The grower has to provide a flock sheet for the birds coming to the plant BEFORE they arrive-------------partial control
The other parts of this control are
1) only using approved growers
2) reviewing the flock sheets prior to the flock arriving and notifying CFIA if meds were used and no withdrawl noted
3) tissue samples that are done on a routine rotating schedule
No one "control" is adequate to deal with the hazard in this case
Or use freezing as another example
In poultry there are standards about how cold a bird must be over time an X/Y axis with an inversion
I can control water temp, but birds can't pick up too much water
I can control speed of chiller........but that's tied directly to the water temp
I can control the inverse temperature relationship
I cannot do those things with 1 control e.g. the water temp
I can think of a million examples when more than 1 control is needed to control a particular hazard
Charles, come on! You know that some hazards have more than 1 control!
Let's see
Poultry slaughter example
I have VERY LITTLE control over what the animals are fed.............
The grower has to provide a flock sheet for the birds coming to the plant BEFORE they arrive-------------partial control
The other parts of this control are
1) only using approved growers
2) reviewing the flock sheets prior to the flock arriving and notifying CFIA if meds were used and no withdrawl noted
3) tissue samples that are done on a routine rotating schedule
No one "control" is adequate to deal with the hazard in this case
Or use freezing as another example
In poultry there are standards about how cold a bird must be over time an X/Y axis with an inversion
I can control water temp, but birds can't pick up too much water
I can control speed of chiller........but that's tied directly to the water temp
I can control the inverse temperature relationship
I cannot do those things with 1 control e.g. the water temp
I can think of a million examples when more than 1 control is needed to control a particular hazard
Hi Scampi/kfromNE,
My criticism centers around the meaning/intention/acceptability of "Control".
From the document linked in Post 12 -
Preventive controls (see 21 CFR 117.135), as appropriate to the facility and the food, to ensure safe food is produced, including -
From 21CFR117.135 -
(a)(1) You must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
I am curious how 1st (red) is "reconciled" with the (2nd red) (see below).
I deduce CFIA has chosen to "translate" the 2nd (red) into "partial". Hmmm.
So - What the heck is "significantly ......." (eg how does one validate either of these non-explicit interpretations [in fact, IIRC, this concept is a semi-rebirth of ICMSF's long gone CCP2]).
Again quoting -
In an FSP, validation means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards. The extent of validation activities may be less rigorous for some preventive controls than others, or may not be required (e.g., sanitation controls).
In fact, from elsewhere -
The following activities do not require validation
Food allergen controls
Sanitation controls
Recall plan
Supply chain program
Other preventive controls if the PCQI prepares the written justification that a validation is not applicable based the nature of the hazard and the preventive control.
How very convenient. Sort of like defining them as HACCP (PRPs).
I deduce my first query is often answered by Statistics.
I don't disagree Charles. I was merely stating how the FDA compares the two. A hope of many of us - USDA and FDA will be combined into one entity to be run by the USDA. Which would hopefully get rid of the nuances of FSMA.
I don't disagree Charles. I was merely stating how the FDA compares the two. A hope of many of us - USDA and FDA will be combined into one entity to be run by the USDA. Which would hopefully get rid of the nuances of FSMA.
Well, since FSMA is federal law, I doubt merging of FDA and USDA would have much effect on the nuances.
Marshall