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By Lisa Lupo

Under FSMA, FDA inspectors are not just looking for things gone wrong, but are seeking to verify that systems are in place to do things right. How do you audit your sanitation program for verification? Once you ensure you understand what FSMA requires, one option is to set up a system that simulates the traditional Deming Cycle: Plan, Do, Check, Act … repeat.

FSMA’s NEW FOCUS. “It used to be an expectation that if a problem arose, you would correct it, but the wording in FSMA changes that whole idea,” said Sterilex Sales Director Katie Moore. Today, under FSMA’s Preventive Controls rule, the food facility is responsible for mitigating risk, not just correcting problems. As such, Moore said, “FDA is expecting you to prevent problems before they happen. This is huge. It was not the expectation before.” To do this, you need to evaluate your environment, assessing where risk lies.

You also should understand that FSMA characterizes cleaning and sanitation as activities which can be Good Manufacturing Practices (GMP) and Sanitation Preventive Controls (SPC), said Ecolab Food and Beverage Senior Manager, Food Safety Education and Training Tatiana Lorca and Senior Area Technical Support Coordinator Kirsten Howe:

  • As a GMP. Carrying out cleaning and sanitation to have a clean and sanitary environment classifies it as a GMP, and it needs to be done.
  • As an SPC. Used to control a specific microbiological or allergen food safety hazard makes it an SPC. Simply put, an SPC is “cleaning for a specific purpose” to remove a specific allergen and/or a specific pathogen.

As such, “it’s very important from an auditing standpoint that you have plans outlined of what you would do in certain situations,” said Perfex Sanitation Marketing Director Michael Dougherty.

THE PLAN. “A good internal sanitation audit will document what is being done right, and help improve areas that need it,” Lorca said. So, a first step is developing a team with a lead auditor and team members from as many departments as possible, then developing or collecting the tools you will need.

Once this is done, you need to identify the key risks of your process and products, Moore said, asking, “Where does your plant need to do something to prevent risk?”

To assess this, Howe said, “Identify what you will need to look at, where you will look, and who will conduct the audit; identify the documents and records to be reviewed, such as Sanitation Standard Operating Procedures (SSOPs), the master sanitation schedule, ATP/micro results, titration records, CIP records, pre-op inspections, etc.”

But it is never enough to simply look at documents and records, rather, she said, a part of the planning stage must include identification of visual observations that should be made, e.g., of the equipment itself, of staff carrying out the cleaning and sanitation activity, and of samples that should be taken.

DO. Consider the entire process, Howe said. Audit the documentation of sanitation activities (e.g., conduct a paper audit). Are you completely documenting what you do? Then audit the actual activity: Observe sanitation practices in processing areas as they occur, take actual measurements of chemical concentration, ATP testing, allergen testing, etc. Then document all observations and results in an objective manner.

When assessing issues, it is important to consider if it can be fixed through your processes, Moore said. This would include such things as ensuring airflow moves backward from finished goods to raw, even while product moves from raw to ready-to-eat, and having procedures to keeps tools and equipment separate.

One of the most important things you can do is color code cleaning tools and keep each area’s tools in designated locations, Dougherty said. This could mean placing them in designated spots on a peg board or hanging them in a designated storage area. “You can make up your own plan as long as the tools remain in the area they are intended for,” he said. This also makes it easier to keep track of the tools and maintain or replace them as needed.

But, Moore said, there are many facilities in the industry that have been converted from non-food plants, for which it may not be possible to change the process to prevent risk. If so, other preventive action should be taken. For example, if the facility has hallways through which cross-traffic cannot be prevented, a footbath, foam, or dry chemical should be used in areas of high-risk.

Another example Moore gave was ensuring that you have a program in place for any used equipment that is purchased or otherwise brought into the facility. “What is the procedure for disinfecting the equipment — and for validating it?” she asked.

Whether conducting cleaning on new, used, or existing equipment, “Machinery is an important area because there can be inaccessible areas,” Dougherty said. “Sometimes these will need to be torn down to maintain cleanliness.”

In conducting the audit, it also is wise to pay attention to areas that are commonly found to be lacking or incomplete. A few of the most common issues are:

  • Incomplete documentation of non-routine activities which are typically documented in the master sanitation schedule. The work may have been done, but if it was not on the daily form, it may not have been documented.
  • Cleaning and sanitizing of the entire environment: floors, walls, ceilings, and surrounding areas, not just equipment. Food-contact surfaces tend to be a priority in pre-operational inspections, and thus become a main focus for the sanitation team. But there must be a focus on the entire plant to ensure procedures are followed for cleaning the environment as a whole.
  • Scheduled deep cleans and tear downs, which require extra time from production and coordination with other departments, often are delayed due to production needs. If they are a part of the GMPs or SPCs, they must be completed.
  • Operational sanitation activities that take place during production and typically include debris and trash removal, shift-change sanitizing, and general housekeeping activities.
  • Areas connected to ready-to-eat rooms. Too often items are carried into these areas without proper management of the entry way or other preventive action being taken.
  • Studies have shown floors and drains to be of high risk for Listeria, Moore said. “It makes sense because that’s where everything ends up.” If you assume floors have active Listeria and you don’t have any controls in place, equipment and shoes could be redepositing the bacteria.
CHECK. Although you are not required to verify GMPSs, any cleaning or sanitation activities designated as an SPC must be verified, Lorca said. Neither are required to be validated under FSMA, but, she added, “Many facilities choose to do so whether as general practice, or to meet the requirement of validating prerequisite programs under a Global Food Safety Initiative (GFSI)-recognized food safety scheme.”

What’s the difference?

  • Validation is the scientific proof that a control measure should be and is effective at controlling the specified food safety hazard. Simply put, it is the proof that the SPC is effective at removing the target (allergen or pathogen) that it was designed to remove. “This is where product labels, product usage guides/catalog sheets and advice from your chemical product supplier can help so that you can ensure the chemical products you have chosen to use will do the job, are compatible with your equipment and water, are appropriate for your soil conditions, are safe, etc.,” Howe said.
  • This can be of particular importance if there has been a process change, Moore said. For example if a new dry floor sanitizer has been employed to prevent an environmental risk, be sure you have applied it properly, are using the correct amount, and are setting yourself up for success. “Those are the things an auditor will look at,” she said.

    To validate GMPs or SPCs: Carry out your SSOPs as documented and collect data using recognized methods and the best science available (e.g., protein-specific test, micro swabs, surface or rinse-water testing). Do this enough times to provide confidence in your data. Once you have validated your SSOPs, make sure they are documented, complete, and reflect what needs to be done; then train those responsible for carrying out the sanitation activity accordingly.

  • Verification is the scientific proof that a control measure has been carried out consistently and in accordance with its design. Simply put, it is the proof that an activity (or activities) is in place, is being followed according to plan, and is being carried out consistently. This follows validation and should be done at consistent frequencies. You also should revalidate as needed, e.g., when there is a significant change in the facility, equipment, process, etc. that may impact the ability for those responsible for carrying out the sanitation activity to achieve the expected results.

ACT. “Although FSMA does not require corrective action for any preventive control except process PCs, which would be a traditional CCP, it does specify that for SPCs, corrections must be carried out,” Lorca said. “So correction will need to be carried out when deficiencies are found, and these actions and expectations must be communicated. Sites should be encouraged to look for patterns in the results and see if formal root cause analysis and corrective action is needed.” It is a good idea to take photos if appropriate, both before and after the correction.

“Be sure to have a plan in place on how corrections are carried out and a plan that will enable the team to communicate results effectively to those responsible.” Although FSMA doesn’t require it, it is good practice to look for patterns in the results and see if formal root cause analysis and corrective action is needed.

“The audit does not end when the results and expected actions are communicated,” she said. “There should be follow-up to ensure the correction/corrective action was carried out and was effective.”

READY FOR FDA’s INSPECTION. “The (FSMA) change in direction and expectation is forcing plants to provide a critical eye to these areas and assess everything,” Moore said. But if you are prepared with your program, training your employees with documented procedures that are readily accessible for employees and inspectors, and conducting in-house audits, you will be much more prepared when an auditor or FDA inspector arrives at your door.

“You can’t make clean food inside a dirty plant,” Lorca said. Thus, the sanitation audit should be properly planned, carried out, recorded, and used, but, she said, “Keep the audit simple and doable so that it does not become a burden for the team or the facility and to ensure it is effectively carried out and used with the constant goal of improvement.”

This requires an investment, and that investment will be reflected in the program’s success. As Dougherty said, “I’ve found that whatever the facility wants to invest in its cleaning process justifies whether or not it is kept up to par.”

The author is Editor of QA magazine. She can be reached at llupo@gie.net.