Validation. It’s not a word that piques most people’s interest when they first hear it. But if your occupation involves any food safety responsibilities you probably know validation is one of the most important things you do. Proper validation helps ensure the integrity of your company’s food safety programs. It’s one of the most common areas where non-conformities occur in food safety audits, and if not done properly can potentially lead to a recall, consumer illness, or death.
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Initial validation of food safety systems and its controls help make sure that each program works effectively. Revalidation acts as a secondary check on systems. During this process, employees and systems can be redirected if issues arise before they become serious concerns. Validation protects the company, its employees, customers, and consumers. Additionally, proper validation is an important part of developing a food safety culture—ensuring what we are doing is effective rather than just going through the motions because we think it’s what we’re supposed to do.
Learning from Recalls
The industry can learn a lot from companies that experienced recalls and regulatory action. One of the most well-known and widely-discussed cases of “what not to do” is the Peanut Corp. of America outbreak and recall in 2008-2009. The company made some bad choices, such as reportedly shipping product known to contain Salmonella, and having a facility ridden with pest activity, holes in the roof, and other food safety issues. One key mistake was not validating its programs. The company used its roaster as a control for biological hazards, and yet had not conducted any sort of validation to establish suitable process parameters to achieve a 5-log reduction of the target pathogen species. It’s also fairly obvious the company didn’t validate the effectiveness of its pest control and maintenance programs. If Peanut Corp. of America had process validation in place, it would have seen the gaps in its system and reacted accordingly.
In another example, Death Wish Coffee recalled its products in 2017. The company determined that although nobody had gotten ill at the time of the recall, there was a possibility of botulism from its nitrogen-infused product. The risk was due to the product’s formulation and lack of a process for eliminating the risk of Clostridium botulinum growth.
These instances show that any one company can have a very real impact on the entire food industry. In 1996, Odwalla was involved in a recall caused by improper validation. The company sold products containing apple juice that wasn’t pasteurized and had E. coli 0157:H7. More than 65 individuals became ill from the products and one child passed away. As a result, the FDA interjected itself into industry practices and shortly thereafter created regulations requiring all juice be pasteurized through a valid system.
There are other relevant outbreaks and recalls in the industry in which processes were not validated and consumers suffered the repercussions. Suffice it to say, the importance of validation in a food safety program cannot be overstated.
FDA’s View on Validation
The FDA applies validation in a relatively limited way for the food industry. According to the Food Safety Modernization Act’s Preventive Control Qualified Individual (PCQI) course, of the four kinds of preventive controls, only process preventive controls are required to be validated. In the PCQI training, Lead Trainers also discuss how a company may, in some cases, validate an allergen preventive control. In this instance, think of a clean-in-place (CIP) system, where process parameters such as time, temperature, fluid flow rate, and chemical concentration can be consistently managed, allowing the process parameters to be validated as effective.
FDA defines validation as:
“Validation means obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified hazards.”
In those cases where validation is required, the FDA intends for the approach to be as rigorous as possible. Gathering any relevant data, regulatory guidance, and additional resources ensure that processes and the food safety plan as a whole are valid.
Let’s use metal detection as a simple example, since it’s a common control and would typically be considered a process preventive control (it’s often designated as a critical control point). Some companies have their detector checked by a qualified third party, which is often referred to as “calibration,” and based on those results they will consider it validated. But what’s missing? They didn’t conduct a thorough yearly review of consumer complaints. They didn’t examine their internal process data, looking for trends in equipment performance. They didn’t review finished product inspection results, if those are available, for any indicators of a potential problem.
These are all valid pieces of information needed in a proper validation to ensure the device is working correctly. In other words, when it comes to validation (effectiveness), things aren’t always as simple as they may appear, and we really need to dig below the surface to be as detailed and comprehensive as possible, focusing on avoiding “worse-case” outcomes.
GFSI’s Broader View
Global Food Safety Initiative (GFSI) programs, which are HACCP (Hazard Analysis and Critical Control Points)-based but also contain additional requirements, take a similar view of validation as the FDA but are typically much broader. The schemes often require companies to have a documented process for validation of the things FDA would look for. For example, validation of: the food safety plan, critical control points, changes to food safety programs, CIP systems, shelf life, rework activities, and product cooking instructions (if present).
Notably, under the Safe Quality Food (SQF) standards, all elements of the program are required to be validated, as a whole. Any of the GFSI programs require this, in spirit, but the SQF requirements make it a bit more rigorous.
Help with Equipment Validation
Many industries have established experts who are referred to as “process authorities” and assist companies with validation of certain critical processes. This is typically limited to processes intended to control pathogens, such as canning processes and pasteurization. There aren’t always official recognition processes for these individuals, but some industries and trade associations may be able to make recommendations.
In absence of this option, there are other ways to get help. The FDA has a Technical Assistance Network (referred to as TAN) on its website, where visitors can ask questions about how to validate their processes, or who might help do so. University extension agents can be contacted at universities such as UC Davis, Cornell, and Kansas State that may facilitate connections to an expert.
The Role of Internal Audits
Internal audits are a great tool, and an important part of a program. As with any other program, they can be done well or they can be approached with a “check the box” mentality—simply getting them done to satisfy the requirements of certification. If done properly, in many cases an internal audit can also function as validation of a program; killing two birds with one stone.
An internal audit completed to simply meet the requirements of certification might include one visit to the production floor, watching the activity for a few moments, and reviewing a few records. This might be considered an internal audit, but so much more can be done to validate.
An internal audit should include:
- Assessment of the procedure for any needed changes and to ensure it meets regulatory and certification requirements;
- Observation of the operation on the production floor, on all shifts;
- Completion of staff interviews to confirm their understanding;
- Review of training records to verify staff are suitably trained per program requirements;
- Review of through sampling of records of the program, looking for any relevant trends or issues that have arisen;
- Evaluation of customer or consumer complaints that looks for anything relevant to the program; and
- Consideration of any other processes potentially affected by this one, and review those programs as well if relevant.
A thorough internal audit, like described above, is a great way to validate a program—thereby ensuring a high level of confidence on the controls’ effectiveness.
Get the whole food safety team involved, and others if relevant. Validation isn’t something one person can do on their own, it takes a comprehensive approach that only a team can provide.
Validate the program as a whole when it’s first created, then at least annually thereafter or on any significant changes.
In order to validate a plan as a whole, review all programs first. Then take a look at everything together and judge if the program is working as designed.
Validating controls means reviewing any potential hazards in the ingredients or raw materials, finished products, and processes. Follow the HACCP approach:
- Identify any potential hazards—do this thoroughly, using relevant resources;
- Evaluate significance of each hazard—determine what sort of control is required;
- Identify the right control—evaluate what is currently in place to confirm it’s the appropriate control;
- Set up critical parameters for each control, and implement programs for monitoring, corrective actions, and verification; and
- Reference FDA’s guidance on the Preventive Controls rule, particularly Appendix 1.
In addition, create a schedule for all verification and validation activities for the year, and issue assignments to responsible parties (activities should be saved on employees’ calendars). This needs to be a team approach. If another meeting or activity takes precedent, make sure the event is rescheduled, not ignored.
Kimble, the senior food safety manager for Safe Food Alliance, leads voluntary facility audits in the SQF, HACCP, and Costco schemes. Reach him at JonK@safefoodalliance.com.
For more information on internal auditing techniques and developing programs, check out Safe Food Academy’s web-based training at https://safefoodalliance.com/learning/.