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From: Food Quality & Safety magazine, June/July 2007

Create a “Closed Loop” to Ensure Quality

Sound Auditing and Documentation Bolster the Validation of Sanitation Processes

by Robert Burgh

It was time for the plant’s yearly audit. The auditor was inspecting the plant along with the sanitation manager. After they were done with the walk-though, they went to the sanitation manager’s office to review the records.

The auditor asked the sanitation manager for the records indicating the last time a certain machine was cleaned. The sanitation manager said, “That’s OK, you can take my word for it.” The auditor continued and reviewed the employee’s records. The next question was, “May I see the training certificates and the renewals?” The sanitation manager said, “That’s OK, you can take my word for it – everyone’s training is up to date.” The auditor then asked to see the plant’s self-audit records. The sanitation manager said with a big grin, “We did great on them; you can take my word for it.”

After saying the plant looked “superior,” the auditor was ready to leave. The sanitation manager asked, “Where’s our certificate?”

The auditor smiled and said, “That’s OK, you can take my word for it,” while walking out the door.

The point of the joke is that clean is no longer good enough. Documentation and auditing are part of sanitation. They help produce a closed loop with quality assurance to provide validation of a facility’s entire food safety program.

Regardless of the size of the plant or organization, the basic framework is the same when building and reviewing sanitation and self-auditing programs.

The Sanitation Cycle

The sanitation cycle is made up of four parts. The first part is the Sanitation Standard Operating Procedure (SSOP) for the equipment and areas. Nothing about how to clean and sanitize is left to chance, especially when allergens are involved.

The steps, intervals, estimated time required, chemical used, and amounts are to be included. When creating SSOPs, plan for and create the changeover and allergen changeover SSOPs. When needed, the changeover SSOPs can usually be copied from the main SSOP and adjusted as needed (typically by deleting extra tasks or adding QA sign-off).

The second part is the schedule. This is the when the tasks are to be performed. The scheduling on manual systems can be split into Master Sanitation Scheduling (MSS) and “Daily Tasks.” The MSS items are tasks performed every week or longer, such as cleaning the “Overhead and Pipes in Warehouse” every 26 weeks, which would take eight man-hours. The daily tasks would include items like “Wet Clean Filler Unit No. 2,” which would take one man-hour.

The third part is performing of the tasks. In the past, this alone was enough to be considered sanitation.

The fourth part is documenting who completed the tasks and when. For auditing purposes, include signatures and dates. The staff that did the work, not just the scheduled staff, must be included in the documentation. Include reasons tasks were not completed along with the list of tasks.

Of the four parts of the sanitation cycle, only the third is visible on a daily basis to most plant staff. It necessarily gets the vast majority of the workforce and the priority. The other three parts are just as important for long-term food safety.

Clearly documenting the SSOPs provides the sanitation department with a number of clear benefits. It helps reduce ambiguity when performing tasks. There is no doubt what is expected of the staff. It allows supervisory staff to focus on higher-level issues instead of repeating items. By having the SSOPs documented, accountability is built in. The staff performing the work, supervisors and the sanitation manager all have defined accountability by having documented SSOPs.

The SSOPs are also used for training and recertifying staff. New staff can use a printed copy of the SSOP to learn how to clean a specific piece of equipment or area. Budget and manpower justification is difficult for most plant sanitation departments. SSOPs that include manpower forecasts make manpower calculations possible with the backup documentation the front office needs.

Scheduling is a logistics function. Sanitation must work with production and engineering to determine when equipment and areas are available. The necessary skilled manpower must be on-site to perform the tasks and have the plant ready for production on schedule.

The history of the sanitation tasks scheduled, performed and not performed is useful for several reasons. Including reasons work could not be completed provides the documentation needed for audits. The auditing department needs to know not only what work was done but what didn’t get done and why. Include all the team members who did the work and the time spent.

Reviewing the history takes the guesswork out of adjusting SSOPs. Over time, deficiencies in SSOPs will become apparent and require adjustments.

Reviewing the history will help determine what tasks must be added, intervals changed, or instructions modified. Along with adjustments, history is used for troubleshooting sanitation problems in areas that were previously not a problem.

The history will show, week to week, if all tasks were completed and by whom. If tasks were not done because of lack of downtime, it can be brought to production’s attention.

By reviewing the specific historic tasks, it can be determined whether there is an interval issue. Comparing the actual manpower with the forecast in the SSOPs will help justify budgeting requests.

Keeping in mind that forecasted time does not usually match actual time, the history’s actual times can be helpful in adjusting the SSOPs and budgeting. If the history is cross-referenced, it is useful for employee reviews. For example, if summed by staff member and equipment or area, completion ratios can be calculated for each employee.

Auditing

Food processing facilities require not only sanitation, but the checks and balances of auditing and validation. The main reasons are best practice, customer requirements and ethics.

It is a best practice to self-audit and conduct third-party audits of sanitation and records. Self-auditing gives plants the opportunity to review sanitation and always look for missing HACCP or possible contamination points. Never accept “We always did it that way” as good enough.

Customer requirements are the second main reason for auditing and validation. Most national and regional customers require facility audits. Audits can be done by a customer’s staff or third-party auditor.

The other main reason for auditing and validation is ethics. It is every food company’s duty to produce its product safely.

Self-auditing provides the method to set up your own validation program and minimize surprises during third-party audits.

Depending on the size of the plant, self-auditing typically is set up in levels. The levels provide documentation and support between each level of management in the QA/sanitation loop.

For most facilities, self-auditing is clearly defined in three levels. The first is intended to report back to the food safety team that performed the sanitation. This level of inspection is very detailed and may mimic the sanitation procedure in listing specific points on equipment and areas. In this case, a specific equipment or area is picked and the audit team effectively follows the SSOP in checking the sanitation. Items not on the SSOP can also be noted.

The next level of self-auditing is to inspect a production line or zone of a plant. The inspection team may rotate self-audits to cover the entire plant within a specific number of weeks.

The top level of self-audit is to inspect the entire plant the way a third-party auditor or customer would.

Based on the department functions or company standards, self-auditing can be handled by the QA department, the sanitation department or a team comprising members of different departments, including sanitation, production and engineering.

Self-audits document issues like food safety, cleaning practice, pest control, maintenance for sanitation and operational practice. The inspection team must also determine what corrective actions are needed and what preventive actions (short term and long term) are required so the problem doesn’t recur.

Validation

Getting the findings from self-audits back to the sanitation team to act on is important. Sanitation can then be proactive in adjusting the SSOPs, modifying scheduling, training staff or attempting to get more downtime.

Sanitation should do periodic long-term review of self-audits and third-party audits to look for repeats in the findings in a given area. Tracking and correcting trends before they become major issues proves the validation cycle is functioning.

QA should also review self-audits, looking for inspection points to add as well as to follow up on inspection findings. Comparing the results of self-audits and third-party audits can be a useful reality check.

Sanitation, auditing and validation create a closed loop. Together, they help plants create an ever-improving sanitation department. It helps QA communicate better with sanitation. It provides a method for follow-up on issues found. The documentation of staffing helps the front office better understand sanitation budgeting requirements. The forecast times along with task intervals help sanitation work with production for downtime needs. These systems can be set up either manually or with computer-based tools.

Robert Burgh, president of Nexcor Inc. (Suwanee, Ga.), can be reached at 770-831-9191 or Robert_Burgh/nexcortech.com@NexcorTech.com.

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