Verification and Validation of HACCP

Verification and Validation of HACCP.

Hazard Analysis Critical Control Point (HACCP) is a mechanism meant for ensuring food safety. It is a comprehensive set of guidelines that straddles across the food supply chain, right from harvest till the time it is consumed.Being such a systematic and total approach; HACCP attaches utmost importance to prevention of problems arising at any point in the food chain. The established method by which HACCP seeks to accomplish this is what is called verification and validation.

Let us get to a verbatim understanding of what these mean in HACCP lingo. Based on the definition of the word “verify” as meaning a way of establishing the truth or accuracy of something; HACCP defines “verification” in this context as “…those activities other than monitoring, that determine the monitoring, that determine the  validity of and compliance with the HACCP Plan”.

Logically following on this, since to validate is to corroborate or substantiate or confirm something, HACCP seeks to establish the validity of the HACCP plan by requiring participants to provide actual, factual proof of compliance to HACCP guidelines.

Armed with a strong set of actions, HACCP seeks to strengthen the food supply chain with its set of safeguards.

Purposes of verification and validation

The HACCP has clear-cut expectations in mind about the purposes of these twin mechanisms. The purpose of verification is defined in the following:

Components of the food chain need to determine if HACCP Plan is working. They need to check periodically if hazards are being reduced by the HACCP Plan. They also need to ensure that operations are in compliance with the HACCP Plan, and make sure HACCP is being implemented properly.

On the validation aspect, HACCP seeks to ensure that all the scientific and technical information is collected and evaluated to make sure that the HACCP Plan is working effectively, and when done so, is effective in controlling the hazards.

What needs to be evaluated?

HACCP attaches importance to what needs to be evaluated for Verification and Validation.  Primarily, lethality and stabilization factors, referred to as “cook and chill”, and processing room temperatures that may be above 50° F need to be evaluated.

References:

http://www1.agric.gov.ab.ca/$department/deptdocs.nsf/all/afs4338

http://www.foodsafety.unl.edu/haccp/principles/Principle%206%20Verification%20Procedures.pdf

http://www.mass.gov/eohhs/docs/dph/environmental/foodsafety/retail/haccp-guide.pdf

 

Thanks & Best Regards,
John Robinson
GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Web: www.globalcompliancepanel.com
Email: john.robinson@globalcompliancepanel.com

 

Why is Computer System Validation Important in FDA Regulated Industries?

Asking why Computer System Validation (CSV) is important in FDA-regulated industries is like asking why an engine is important to a vehicle.

Before going on to get an understanding of this issue, let us understand that there is a difference between the ways in which the term “validation” is used in the general area of computers and that used in FDA-related circles. In the field of computer science, the term means the ability of software to meet its stated requirements. For the FDA, validation of a computer system incorporates all activities that go into a computer system and these should be documented and made available to the FDA. We could use the word “verification” to associate the same meaning and understanding of what “validation” means to the FDA.

All-encompassing term

The critical importance of computer system validation in FDA regulated industries can be learned from at least two perspectives:

1.    When a company is carrying out systematic CSV; it nips potential serious problems in the bud by preventing software problems from reaching production stages and environments. When a problem in a Life Science software application reaches the production environment, this can lead to serious adverse consequences. On the one side, there is the human element of getting the CSV validation wrong, which can result in serious product consequences, which can be disastrous to the patient’s health; on the other, businesses that get their CSV wrong can also face anything from lawsuits and heavy penalties to having to shut shop permanently. Long drawn out court cases can result in serious problems including bankruptcy.

2.    FDA’s regulations requiring companies to carry out systematic CSV have the effect of law, which means that companies that come under the ambit of the FDA are legally bound to follow the guidelines set out by FDA’s regulations. When companies fail during an FDA audit; it can invite inspectional observations (“483s”) and warning letters.

The most important element of CSV that companies need to bear in mind is that they need to get their validation right alright; they also need to get it right stage by stage. Some companies have tried the short cut method of overlooking or circumventing a step or two. While this may give them short term savings; their long term costs are far higher than these savings.

References:

http://www.stsv.com/pdfs/STS_CSV_article.pdf http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm

 

Thanks & Best Regards,
John Robinson
GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Web: www.globalcompliancepanel.com
Email: john.robinson@globalcompliancepanel.com