Building a Clean Slate
Aug. 1, 2012
by Dan Malovany
Good Manufacturing Practice (GMP) inspections and, to a greater extent, Global Food Safety Initiative (GFSI) certification audits do a good job of reviewing programs and making sure they are up to date and properly implemented. However, contamination issues do not happen on paper; they happen on the production floor, in the warehouse or the packaging room. FS 360 focuses there.
AIB International, Manhattan, KS, developed FS 360 to fill the void left when a facility chooses to go strictly with program-focused audits and cursory on-the-floor inspections. With the FS 360 program, the auditor is meant to get dirty. The audit cannot be rushed. It is truly meant to be a deep dive into the facility GMPs.
The program is intended to be educational in nature. AIB’s history and arguably its strongest skill set is its ability to carry out a deep physical inspection of a processing area: open the equipment; climb the silos; go on the roof; and dig, dig, dig to identify areas where contamination could occur.
Maureen Olewnik, AIB’s senior vice-president, food safety and technical services, along with Betsy Blair, head of GMP audit services, explain how FS 360 works and how it’s designed to improve food safety in the long run. For more information on AIB’s various programs, visit www.aibonline.org.
Dan Malovany: What are the guiding principles behind a FS 360 audit?
Betsy Blair: FS 360 is an educational evaluation that is designed to train facility personnel how and where to look at the equipment to identify potential or eminent food safety risks, including areas that may have been overlooked in the past. In some companies, there is a high turnover rate for personnel in charge of sanitation. This makes it difficult for those employees to build the expertise and get a deep understanding of the systems needed for an excellent sanitation and hygiene program. It can take six months to a year to train personnel, and when there is a high rate of turnover, the experience that has been gained can be lost. FS 360 helps build that expertise more quickly.
FS 360 can be set up as a scheduled format where it is used as a continuous training activity and used to help the facility identify root cause with follow-up on how to manage the food safety situation.
What prompted the development of the new FS 360 inspection?
Maureen Olewnik: As many facilities move to GFSI benchmarked audits, the documentation is thoroughly reviewed, but the physical audit doesn’t allow for much time to be spent really looking at equipment. FS 360 does that. It is complementary to GFSI audits in that it allows the inspector and the facility personnel to spend time opening equipment looking for areas that may have been missed, and encourage open discussion on root cause and methods of correcting the situation.
It is our belief that the proverbial sweet spot in the development and implementation of a robust food safety program is at the intersection of training, program audits and deep inspection. This 3-circle approach provides the necessary educational approach and review processes that will help design and implement programs as well as provide continuous oversight both in the office and on the floor. FS 360 assessment is a critical component of a fully balanced food safety system.
How does AIB FS 360 differ from the inspections that AIB did in the past? Does it replace the current AIB Consolidated Standards for Inspection scoring system?
Ms. Blair: The AIB Consolidated Standards for Inspection is the document developed as the basis for the current AIB inspection. This is a scored inspection, where both a physical evaluation of processing areas and a document review are carried out in order to satisfy requirements outlined by the Food and Drug Administration (FDA), Codex Alimentarius and industry best practices. This scored inspection remains a very important part of the AIB offerings. It, too, is training-based while providing a manufacturer with a way of monitoring its activities within and between facilities.
FS 360 is different in that there is no score, and the need to review the entire facility is not a requirement. The AIB inspector can set up the inspection for a time when equipment is down, during the third shift, or at another time that will allow them to look at things that would not be available during regular processing times. The inspection is 100% on the floor and with no worry of being scored. The staff is encouraged to show their “dirty laundry” and allow the inspector to help to identify and teach the employees better ways to do their own internal inspections.
What are the advantages of this system over others for the baking and snack food industries?
Ms. Olewnik: The advantage of this program is learning. Skilled AIB inspectors not only find not-so-obvious food safety issues, but work closely with the facility to identify methods of looking at and identifying potential problems, and providing ideas on ways in which the issues can be fixed. Again, with no score, the customer is encouraged to be open and honest about things they have seen but can’t seem to rectify. We encourage open dialogue in conjunction with a thorough evaluation. The area of the facility evaluated can be identified before the inspector gets to the facility. It can be based on issues that are identified but not solved. Or the inspectors can simply follow their nose and see where it takes them. So far, the outcomes have always been highly enlightening.
How does AIB FS 360 complement current GFSI schemes?
Ms. Blair: GFSI audit schemes provide a thorough review of written food safety systems and programs with lesser review of the different areas of the physical production floor. AIB FS 360 provides a thorough and deep assessment of equipment while it is down. This allows the inspector and facility personnel to spend all the time needed to look closely at the physical production area. The inspector will work with the facility personnel to identify root cause and provide direction and methods of improving food safety. No documentation is reviewed unless an issue is identified that requires a document check to try to identify a root cause. The two work well as an overall review of facility activities.
How does FS 360 integrate with the GFSI and Food Safety Modernization Act (FSMA)?
Ms. Olewnik: FS 360 is not designed to integrate, but to align and complement GFSI by providing a deep physical inspection and educational component that is not allowed in the GFSI audits. This process provides an independent, supportive instructional approach to aid in identification and evaluation of potential food safety issues. Additionally, digging into processes on the production floor will help support the training requirement for FSMA.
How does the inspection and education process encourage facility ownership of food safety and sanitation?
Ms. Blair: The more information and expertise that sanitation or hygiene personnel have, the better they can help protect the product by ensuring a clean facility and product handling areas.
Why is report writing kept to a minimum?
Ms. Blair: Companies have a choice of the type of report they receive. Some companies have opted to receive a summary that lists the date of the activity and the personnel attending. Other companies have requested an executive summary, and there is another option to have a full report, although that does require an additional day. Again, the point of the activity is to teach and train. We would encourage the facility personnel to take good notes and participate in the activity. The point of the activity is to have both sides work together with an open dialogue and not be concerned about failing an audit.
How has the role of AIB auditors changed?
Ms. Olewnik: The role has not changed. All AIB inspection staff is trained to do a thorough physical inspection and offer guidance to the facility being inspected. This activity simply strips out the program review portion of our current AIB Consolidated Standards inspection, eliminates the rating and puts full focus on the assessment of the facility. Digging and training are key.
How does AIB FS 360 encourage ownership of the issues found during the process?
Ms. Blair: The inspector partners with the facility personnel to help identify issues and their root cause and come up with both short term and long term solutions, where possible. The program was designed to encourage ownership of the findings and help to partner with the facility employees in identifying solutions.
What options such as third shift inspections are offered?
Ms. Blair: For the FS 360 to be most effective, equipment should be down or not operating. This is the only way the inspector and facility personnel can open the equipment, look inside and find any issues that might impact the safety of the product being produced. The inspection can be conducted at any time, day or night, on any shift and any day. Most audits and inspections are carried out 9 to 5, Monday through Friday when equipment is running and access is limited. Facilities rarely have outside eyes reviewing activities during off hours or late night shifts. This approach provides a more complete overview of production challenges in total.