Is it plausible for a CCP to have more than one critical limit?
Does anyone have any experience with operating a CCP with more than one critical limit?
We are looking to use an "either/or" scenario for one of our CCP's due to methods we plan on employing for monitoring the process step itself.
One method involves using validated settings where the critical limit would be the use of those settings and the other involves us obtaining certain data from manual checks.
We can demonstrate that both "critical limits" are capable of maintaining control, but by having more than one metric to work to would allow us to use validated settings and intervene for quality related reasons.
Any thoughts would be appreciated!
Cheers
Danny
Ah, so that is not actually more than one critical limit-but more than 1 method of verifying that the CCP is within limits
That is a good idea as long as your monitoring record allows for a clear recording of the data in your either/or method
Two experiences in my history come to mind:
1. I've had a case where we processed some product under a HACCP plan, and other product through the process under a Food Safety Plan. We were a third party processor (we didn't own the food) for sterilization/pasteurization of dry goods. Items were processed as:
- HACCP Plan for products validated for our specific process. Validations in our treatment chamber were product specific, as well as package as our process involved leaving the product in original packaging.
- Food Safety Plan for non-validated products. We could treat product to our known effective parameters, but could not certify a 6-log reduction due to lack of validation.
The validated products were under HACCP as the validation (time/temp/pressure) became the CCP. The FSP called for similar time/temp/pressure controls, but as the process was not validated, we were just guaranteeing the process was followed and it was the customer's responsibility to determine product disposition.
2. Metal detection CCP's. A sister company did third party milling/blending and packaging of dry herbs and spices. Again, we didn't own the product, but had identified that our process line require metal detection due to the nature of our handling. Customers would often specify whether they wanted closed case or open product MD, and our flow charts designated product could go through either type of MD as part of our process.
Does anyone have any experience with operating a CCP with more than one critical limit?
We are looking to use an "either/or" scenario for one of our CCP's due to methods we plan on employing for monitoring the process step itself.
One method involves using validated settings where the critical limit would be the use of those settings and the other involves us obtaining certain data from manual checks.
We can demonstrate that both "critical limits" are capable of maintaining control, but by having more than one metric to work to would allow us to use validated settings and intervene for quality related reasons.
Any thoughts would be appreciated!
Cheers
Danny
Hi Danny,
IMHO it's difficult to give a meaningful response without knowing the context to your query ? Sorry.
Hi Danny,
BRCGS Global Standard for Food Safety Issue 8 requirements and guidance for validation are outlined below.
2.9 ESTABLISH CRITICAL LIMITS FOR EACH CCP (EQUIVALENT TO CODEX ALIMENTARIUS STEP 8, PRINCIPLE 3)
2.9.2 The HACCP food safety team shall validate each CCP. Documented evidence shall show that the control measures selected and critical limits identified are capable of consistently controlling the hazard to the specified acceptable level.
Guidance:
Validation and documentation of critical limits
Documented evidence must be available showing how the control measures for CCPs and other controls, where appropriate, have been validated to ensure they control, reduce or eliminate the hazard to the specified critical limit.
Validation must demonstrate that if the control measures are followed as specified and the critical limits are met (at minimum and maximum levels where a range is indicated), a consistently safe product will be produced. Evidence could come from professional bodies, trade associations, historical processing data, scientific and technical literature or legislation. In addition, scientifically valid experimental or pilot plant trial data or exercises, such as challenge testing, may be required to confirm the capability of the process.
BRCGS Global Standard for Food Safety Issue 8 interpretation guideline offers this: VALIDATION
Validation is defined as obtaining evidence that a control measure (or combination of measures), if properly implemented, is capable of controlling a hazard to a specified outcome. Validation activity is completed before the controls are introduced or when changes are expected (e.g. new products, new processes or new equipment). Validation might include:
• document and data review – previous test results, industry data, codes of practice and legislation may all contain useful
• information
experiments/testing – consider tests on the product or factory environment that will demonstrate control (worst-case-scenario
• tests, final product tests etc.)
challenge studies – for example, microbiological tests to establish whether a micro-organism of concern can grow in the product
• using the relevant time/conditions
modelling – a number of predictive tools are available.
This BRCGS Guidance also states that several worked examples of validation that can be found in CODEX GUIDELINES FOR THE VALIDATION OF FOOD SAFETY CONTROL MEASURES:
VI. THE VALIDATION PROCESS
A range of approaches to validation are available. The precise approach will depend, among other things, on the nature of the hazard, the nature of the raw ingredients and product, the type of control measures or food safety control system selected to control the hazard, and the intended stringency of control of the hazard.
See Approaches for validating control measures in this document
As per Charles’ post, your explanation is somewhat lacking in detail and my question would be are you looking to validate two different “critical limits” for a CCP or are you looking to validate the same critical limit by two methods?
Kind regards,
Tony