10 replies to this topic

[arshsbrar]

is it mandatory to have a training from a certification body/ approved traing person in order to be a PCQI.

 

if not, how can an organization fulfil the requirement of having a PCQI.

[kfromNE]

is it mandatory to have a training from a certification body/ approved traing person in order to be a PCQI.

 

if not, how can an organization fulfil the requirement of having a PCQI.

If you do a search on the forum, you should find the answer. Technically no.

[olenazh]

AFAIK, if you're not exporting to US - you don't have to. 

[SQFconsultant]

No.

[Ian R]

HI

For our clients in the UK exporting to the US we have been told you must have a PCQI or equivalent

but that does not mean that have to do a formal PCQI course

they can be designated the PCQI if they other suitable training and experience

 

We have successfully argued that having the Level 3 Award in HACCP and Level 3 Award in Food Safety along with an awareness of preventative controls is sufficient for a PCQI

 

What we have found is that you are expected to have a PCQI and a deputy, so make sure you have 2

 

regards

[arshsbrar]

As per the comments above, it is clear that training is not mandatory.

 

Since our organization ships products from Canada to the US. How can we designate an individual as a PCQI based on his/her experience.

 

Are there any standard guidelines for this?

[Scampi]

PC.6 Do I need to employ a preventive controls qualified individual (PCQI)?

The preventive controls for human food rule creates new requirements for covered domestic and foreign facilities producing human food to develop and implement a food safety plan based on hazard analysis and risk-based preventive controls. In general, the rule applies to facilities that have to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, there are a number of exemptions and modified requirements that may apply (see 21 CFR 117.5 for exemptions that may apply to your facility).

If no exemptions apply to you, then you are required to have a PCQI develop and implement your facility’s food safety plan. A PCQI is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.

 

https://www.fda.gov/...-questions-fsma

[MDaleDDF]

I always love dealing with the CFR.   Like reading Ikea instructions in Chinese, upside down.  Clear as mud.

 

We're FDA and have two on site, including myself.

[olenazh]

I always love dealing with the CFR.   Like reading Ikea instructions in Chinese, upside down.  Clear as mud.

 

We're FDA and have two on site, including myself.

Exactly! Those government regulatory doc's - it seems like they're made overly complicated/sophisticated/multi-worded/redundant on purpose, so no average person could understand them, to look puffed-up important.

[Scampi]

This part is clear to me in the context of the posters question

 

If someone has been doing the Food Safety Coordinators job successfully (passed inspections/audits repeatedly) for more than a couple of years at said site, the person qualifies as per the portion in red

[kfromNE]

I would designate a backup. In case the main person isn't there.