You have completed your checklist for hiring a food safety consultant. You:
Explore this issueFebruary/March 2017
- Asked your colleagues,
- Reviewed qualifications,
- Interviewed, and
Now, what can you expect before the consultant shows up at your door, when he/she is visiting, and after he/she leaves? There are some key deliverables that should be expected of a consultant despite a myriad of backgrounds, educations, and approaches. This article focuses on the deliverables for a harborage site investigation, but the concepts can also apply to a sanitation or food safety program review.
Quote. Before any travel is planned or documentation shared, obtain a detailed quote of services. Having a signed quote is a good way to start off a relationship with expectations laid out from the beginning. Expect the following.
- Timelines for each service or service type.
- How and who plans travel and how the expenses are charged. How service fees are charged. Some consultants charge extra for weekends, holidays, or hours in excess of 8 per day. Some will charge a lump sum, others a fee per hour. When lump sums are quoted, determine if an accounting of the hours is desired and if so, communicate this up front. If a fee per hour is quoted, ask what happens to the bill if more or less hours are needed for the services.
- Terms of agreement, usually a quote is applicable for 60-90 days from issue.
Non-disclosure agreement (NDA). It is important to know, from both sides, the rules for communication. A mutual NDA is often used to protect both the consultant and the company. Here’s what to expect.
- Categories within the NDA may include a description of what information is considered “confidential,” such as clients, financial documents, employees, HACCP (Hazard Analysis and Critical Control Points) plans, photos, and recipes.
- Term of the agreement, typically one year.
- How confidential information is handled and who handles the information.
- Exceptions during legal situations, such as receipt of a subpoena.
- Negotiations not to subcontract work without written consent.
If the consultant does not have a NDA template, then the company may wish to have one drafted by its legal firm or internal counsel and have it available for use. Not always addressed within an NDA, but a helpful discussion to have with a consultant is with whom the consultant can communicate. For example, can the consultant contact external suppliers, such as a contract sanitation firm or lab? It is best if all communication between the consultant and outside firms are conducted with a company representative present. That way, the company understands what transpired and the consultant understands that the company is engaged in the solution.
With the quote and NDA signed and dated, work can begin. It is most often helpful if the consultant can obtain copies of the HACCP plan, plant diagram, and regulatory correspondence prior to a plant visit. General production room and equipment photos are also helpful. That way, a preliminary glimpse into the process, products, and equipment can be studied. Additionally, a review of existing documentation related to any contaminations, such as environmental monitoring data, corrective and preventative actions, customer complaints, or market withdrawals and recalls, can be done prior to the site visit and allows the consultant a glimpse into any recent past or ongoing issues.
Agenda. Ask for an agenda including the personnel needed. Often the agenda will not be followed precisely because tasks can take longer than anticipated, but usually the first day or specified tasks (equipment tear down, sanitation) are the most critical. The agenda will allow for personnel and production scheduling. The agenda should also include a group debrief at the end of each day so the company’s food safety team who were not present during the day’s events are updated on discoveries and the next day’s priorities and agenda.
Harborage Site Investigation
A harborage site investigation involves looking for a source of microbiological contamination in the plant facility. Expect the following during an investigation.
Site visit. In most cases a site visit is needed. Only in rare instances may an investigation take place without the consultant being on site. In this case, exchange of photos is a necessity. Ask the consultant what he/she will be viewing. It is most instructive to see the equipment moving as it does in production and also to view the sanitation crew from dry pickup through cleaning. If production is still running, viewing pre-operation setup, operations, and shift changes are instrumental to piecing together root causes.
Swabs. Microbiological sampling of the equipment and site will be needed to determine the harborage point. Ask the consultant if he/she will be taking the samples or if the company’s QA team can or should assist. It is always helpful to have a few people handy to label swabs, fill out lab request sheets, note swab descriptions, and, if permissible, take photos. A photo is truly worth a thousand words and comes in handy during team debriefing at the conclusion of each day. As a company outsider, it is often difficult to name equipment in the same terms as the company. Even similar equipment is named something different by each company. Some slicers are named, aptly, “slicer” while others term their slicer a “flux capacitor.” Also, the name of the room can be confusing for someone who is new to the area. Yet these are important aspects to identify swab locations, especially when a swab is positive.
Maintenance. It is always helpful to have someone from maintenance available to remove side panels, motor housings, chain guards, and open electrical panels. Discuss how equipment runs and the maintenance events that may have impacted bacterial harborages. Rare is the case that there is no need to see inside equipment so having those areas accessible for swabbing is an important investigative tool. These sites are the areas where soils can accumulate and bacteria will thrive.
Lab. If the lab is onsite, have available the method of testing, lab employee training, and lab audit documentation. If a third-party lab is used, show the consultant the ISO 17025 certification and show that the methods used for the swabs taken on site are contained within the ISO certification. This is a good double check for the company. Make sure the lab understands there will be an increased sample volume and discuss with the consultant the courier pick-up times so swabbing can be completed each day in time for sample pickup or shipment.
Dry runs. Once a harborage site has been identified through testing and renovations enacted, conducting dry runs to validate that the activities have been successful are a component of the harborage site process. A minimum of three dry runs will be necessary to verify effectiveness of the removal process. Keeping in mind that after each dry run, sponges are taken as a scientific verification, the test times need to be considered. The dry run process alone can add a week to the investigative process.
Time. It takes a number of days to get familiar with the processing environment and equipment. Often swabbing is not completed within the first day and there may need to be multiple swabbing events if the first round was unsuccessful in uncovering the harborage site(s). If samples are shipped then there is usually a day delay and testing can take up to 48 hours additional to a negative result. Determine beforehand if testing will stop at presumptive or if the testing will be confirmed, which may take an additional 5-7 days.
Expected outcome. Discovery of the root cause and any secondary sites is expected. Oversee the harborage site(s) removal and verification that the production environment is free of the pathogen.
- Program review and/or development. During the course of a visit, the consultant will likely ask to see programs germane to the production environment. Program revisions and development are to be expected. One program that is likely to be developed is a Corrective Action/Preventative Action plan that describes and documents practices that immediately correct and further prevent/mitigate a harborage (or other situation) from occurring in the future. This program can, and should, be applied to all other departments as well.
- During the testing phase while waiting for microbiological results is a good time to reassess the HACCP plan. The entire HACCP team will need to be available for this portion of the process.
- The end result of any project is a detailed written report provided by the consultant. In lieu of a report, a letter to the FDA or USDA answering a 483 or Notice of Intended Enforcement/Notice of Suspension, respectively, may be written by the team. If a report to the company is written, it should include background, scope, and outline the findings and next steps of the project. The report, generated in a timely manner, would be expected to include procedures and policies developed or reviewed by the consultant. These documents become the property of the company, which will approve programs, train employees, and implement the procedures. The documents are to align with the company’s current document control policy.
With the Food Safety Modernization Act regulations underway, some companies are seeing gaps in their current programs, especially related to their food safety, sanitation, and HACCP plans. Having a set of fresh eyes look at systems may be of tremendous value. Consider having a food safety professional visit the company. However, setting expectations before, during, and after the visit will improve the outcome of the exercise and experience.
Dr. Deibel is director of microbiology for Covance Food Solutions. Reach her at email@example.com. Baldus is lead trainer/microbiology consultant for Covance. Reach her at firstname.lastname@example.org.