Is it illegal for me to be the only PCQI for my facility?

Hi Everyone,

I recently underwent an audit and the auditor insisted that it is illegal for me to be the only PCQI for my facility.  She stated that I couldn't legally take a day off from work.  Did I miss something HUGE?  The CFR doesn't state that.  The FDA's FSMA TAN doesn't state that.  I'm wondering where this is coming from.  Has anyone else encountered this during an audit? 

Thanks! 

Do you mind me asking how big your company is? I'm about to undergo the training to be the certified PCQI for my company, but we are very small.

I would ask your auditor if she can direct you to where that is written.

We are small, just over a 100 employees.  I disagreed with the auditor when she said that and told her I would look into it.  She referenced 21 CFR 117.  If she had deducted points for it, I would have pressed the issue.  At the time, though, I felt like my face was giving away everything and it was a struggle not to sound condescending.

I'm going to my PCQI training on Monday and I'll make sure to ask about this. Hopefully someone can provide a clear answer before then for you, but still.

Looks like its a case of another inspector that was wrong wrong wrong!!!   I would have pulled out the section and asked politely to point that out to me.........having an expectation that there always be a PCQI on site is nuts----what if it was a small business, but ran around the clock due to the nature of the operation?

Sounds like fear mongering to me if she didn't deduct points but still brought it up; either that or more likely a power tripping inspector

It's not illegal. But you really should have at least two. 

The inspectors comment about "vacation" is valid however. 

The PCQI must review any applicable documents within 7 days. So if you take more than 7 days off from work, "technically" you are not complying with the law.

And what happens if you are out of state on vacation and the FDA walks into your facility to do an inspection?

Marshall

We are small, just over a 100 employees.  I disagreed with the auditor when she said that and told her I would look into it.  She referenced 21 CFR 117.  If she had deducted points for it, I would have pressed the issue.  At the time, though, I felt like my face was giving away everything and it was a struggle not to sound condescending.

Sometimes those are the most difficult parts of an audit.

Marshall

Was this an inspector from the FDA or a third-party auditor? Either way, don't necessary think it is "illegal" except in the sense that Marshall pointed out - paperwork must be reviewed within 7 days.  It's always a good idea to have a backup PCQI in case of extended vacations, emergency leave of absences, etc. 

Not sure what you meant by deducted points? But yeah, *expletive* auditor that's auditing their [mis]understanding of the rule. Was this state contracted? If so what state?

Applicable sections from 117 subpart C, emphasis mine, the point is the PCQI doesn't have to do everything. They have to oversee everything. 

(2) The food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals.

[ on validation] (1) Must be performed (or overseen) by a preventive controls qualified individual:

Within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a timeframe that exceeds 90 calendar days after production of the applicable food first begins;

[on verification] (4) Review of the following records within the specified timeframes, by (or under the oversight of) a preventive controls qualified individual, to ensure that the records are complete, the activities reflected in the records occurred in accordance with the food safety plan, the preventive controls are effective, and appropriate decisions were made about corrective actions:

(i) Records of monitoring and corrective action records within 7 working days after the records are created or within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a timeframe that exceeds 7 working days; and

[on reanalysis]

i) Within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a written justification for a timeframe that exceeds 90-calendar days after production of the applicable food first begins.

 A preventive controls qualified individual must perform (or oversee) the reanalysis.

117.180

 One or more preventive controls qualified individuals must do or oversee the following:

(1) Preparation of the food safety plan (117.126(a)(2));

(2) Validation of the preventive controls (117.160(b)(1));

(3) Written justification for validation to be performed in a timeframe that exceeds the first 90 calendar days of production of the applicable food;

(4) Determination that validation is not required (117.160©(5));

(5) Review of records (117.165(a)(4));

(6) Written justification for review of records of monitoring and corrective actions within a timeframe that exceeds 7 working days;

(7) Reanalysis of the food safety plan (117.170(d)); and

(8) Determination that reanalysis can be completed, and additional preventive controls validated, as appropriate to the nature of the preventive control and its role in the facility's food safety system, in a timeframe that exceeds the first 90 calendar days of production of the applicable food.

c)(1) To be a preventive controls qualified individual, the individual must have 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. This individual may be, but is not required to be, an employee of the facility.

[on implementation records]

(6) Records that document applicable training for the preventive controls qualified individual and the qualified auditor.

I would also add that there is no FDA requirement to have a certification in order to be a PCQI.  If there is someone else in the company who can demonstrate through experience and/or training (not necessarily the official PCQI course) that they are qualified, then that person can cover when you are on vacation (or at any other time).

Im taking from this no matter how small the company is you need a PCQI is that correct? even if we recieve our product prepackaged and labeled already?

If your facility is required to comply with the Preventive Control Rule, then yes, you need to have a PCQI.

Marshall

FDA Says:
"In general, the requirements apply to you if you manufacture, process, pack, or hold human food for consumption in the United States, whether your facility is domestic or foreign. The requirements apply to you if you are required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Entities defined as “farms,” retail food establishments, and restaurants are some of the entities that are not subject to the preventive control requirements because they are not required to register. In addition, there are several exemptions or modified requirements that may apply.

Marshall

correct me if I'm wrong but isn't there a section in the PCQI training stating that not all records have to be signed off by the PCQI and that the PCQI can train an individual

on record review and assign the trained employee to complete this task in a vacation situation? I believe as long as the training is documented and states what documents the trainee

can review in the absence of the PCQI will suffice.

That assumes you have a PCQI, which the OP does not.

Marshall