3 replies to this topic

[Wowie]

Hello all! Long time no see :)

 

We are preparing to start up a new facility (which doesn't have me stressed at all! I'm definitely keeping up with the ever-updating drawings and new equipment and changing products). As I'm working on my Grant of Inspection Application, I was thinking ahead and starting to work on creating some 90-Day Validation documents for different areas of the HACCP plan.

 

In the past, I've used similar documents to support implementation of new equipment install, antimicrobials changes, process changes, etc, but I've not done one for the 90-day initial validation of a brand spanking new HACCP plan. Initially, I was going to make a separate document for some additional important monitoring steps (for example, metal detection is a CCP, but a broader validation for foreign material).

 

I believe that when everyone (the HACCP team, USDA, and the certification body) sits down to review and finalize the initial HACCP plan, it will be easier to pull the CCP documentation and the additional, separate 90 day validation documents. But I'm wondering if the extra verification that goes into that will just be extra work, or if it will be really be the boost in my validation that I'm hoping for. 

 

What do you guys think?

 

Does anyone have examples they've used? I've always used passed down documents, and making sure I get everything on here has gotten my brain scrambled. 

 

 

[Tony-C]

Hi Wowie,

 

I'm not sure I understand fully but to my mind the validation can be done prior to implementation of the food safety plan and this would be my preference unless there was a need for in house studies for validation such as product commissioning trials.

 

§117.160   Validation.

(a) You must validate that the preventive controls identified and implemented in accordance with §117.135 are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility's food safety system.

(b) The validation of the preventive controls:
(1) Must be performed (or overseen) by a preventive controls qualified individual:
(i)
(A) Prior to implementation of the food safety plan; or
(B) When necessary to demonstrate the control measures can be implemented as designed:
(1) Within 90 calendar days after production of the applicable food first begins; or
(2) 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;
(ii) Whenever a change to a control measure or combination of control measures could impact whether the control measure or combination of control measures, when properly implemented, will effectively control the hazards; and
(iii) Whenever a reanalysis of the food safety plan reveals the need to do so;
(2) Must include obtaining and evaluating scientific and technical evidence (or, when such evidence is not available or is inadequate, conducting studies) to determine whether the preventive controls, when properly implemented, will effectively control the hazards; and

© You do not need to validate: .............'

 

Subsequent to this there would be verification:

§117.155   Verification
§117.165   Verification of implementation and effectiveness

 

​Kind regards,

 

​Tony

 

[KTD]

Tony -

 

I think that part of Wowie's question concerns USDA FSIS requirements for HACCP validation - 9 CFR 417.4(a)(1). It requires validation of 90 processing days of data for full validation.

 

 

Wowie -

 

As you noted, you will have to conduct and document an initial 90 day validation for FSIS. You seem to be on track as far as your validation procedure. From past experience, I tend to conduct and document all HACCP activities with an eye on FSIS regulatory compliance and maintain GFSI related materials separately. It's one thing to get dinged on an audit, and something else to get slammed by FSIS. It can be more work this way (although there is a lot of duplication), but since most GFSI audits expect Codex scientific HACCP, while FSIS expects regulatory HACCP, the write-ups are often different. Doing it this way probably won't be a 'boost in your validation', but I have found it heads off unnecessary questions about info required for one body, but not the other.

REMEMBER to maintain the 90 validation and all associated records and doucmentation forever. That was recently a big issue with FSIS, since a lot companies lost/misplaced their initial validation done years ago.

 

Good luck!

 

KTD

[Wowie]

Tony -

 

I think that part of Wowie's question concerns USDA FSIS requirements for HACCP validation - 9 CFR 417.4(a)(1). It requires validation of 90 processing days of data for full validation.

 

 

Wowie -

 

As you noted, you will have to conduct and document an initial 90 day validation for FSIS. You seem to be on track as far as your validation procedure. From past experience, I tend to conduct and document all HACCP activities with an eye on FSIS regulatory compliance and maintain GFSI related materials separately. It's one thing to get dinged on an audit, and something else to get slammed by FSIS. It can be more work this way (although there is a lot of duplication), but since most GFSI audits expect Codex scientific HACCP, while FSIS expects regulatory HACCP, the write-ups are often different. Doing it this way probably won't be a 'boost in your validation', but I have found it heads off unnecessary questions about info required for one body, but not the other.

REMEMBER to maintain the 90 validation and all associated records and doucmentation forever. That was recently a big issue with FSIS, since a lot companies lost/misplaced their initial validation done years ago.

 

Good luck!

 

KTD

 

 

Thank you! Yes, I apologize for not being more thorough with my explanation in the original post.

 

After sleeping on it a few days, I did go ahead and create documents for 90-Day Validations of several different steps in the process, and do intend to have that separation between FSIS documentation and GFSI documentation. A nonconformance or suggestion during the initial GFSI certification may delay us receiving our certificate, but an issue with USDA will delay plant startup.