You’ve received a less-than-stellar audit as you’re preparing for GFSI accreditation—not a good sign that your facility will also pass FSMA muster. You’ve contacted an architectural and engineering/construction (A&E/C) firm to see what you have to do to correct the problems the auditor has cited. It won’t be easy, but the firm’s engineers and architects say a new building isn’t necessary; some renovations may be all you need to fix the problems and pass the audit.

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So, you’ve decided to stay put and renovate. But first,  you’ll have to assess how the plant renovation can be done with the least disruption—and without endangering food safety. When you’re finished, your plant will be FSMA ready and more efficient to boot.

System integrators and engineering firms like Boccard Life Sciences have seen it all when they do a walkthrough of an older facility, including equipment issues. “We see quite a few PMO-noncompliant pasteurizers,” says Christian Fitsch-Mouras, Boccard CEO. “Other common issues are associated with CIP systems and the cleanability of the equipment.” Sometimes, facility issues affect worker safety which, in turn, affects food safety. Fitsch-Mouras continues: “We find a spectrum of safety environments from one facility to another. Some are just OSHA compliant, while others have safety standards and policies that go much beyond OSHA, especially when it comes to traffic inside the facility.”


What to do?

“Failures during a food safety audit are generally placed in three categories: minor nonconformity, major nonconformity and critical nonconformity,” says Chris Brink, Jedson Engineering, senior packaging engineer. If, for example, it’s an SQF audit, the staff will want to know the next step and who needs to meet with the auditor.

“Determining who will meet with the auditor is usually up to the plant as [the staff] is ultimately responsible to correct an issue as soon as possible or in accordance with SQF auditing guidelines,” adds Brink. “Depending on your industry sector, nonconformances of a minor nature receive an audit score of -1 [point] each and must be closed out within 30 calendar days; major nonconformances are -10 each and must be closed out within 14 calendar days. Scores for critical nonconformance are -50 points each and result in a failed audit. A meeting with the A&E/C representative could help plant management understand the costs associated with the repairs and the time it will take to implement them.”

“A design/build firm should be engaged to review the audit and the issues,” says Stuart Jernigan, preconstruction manager, A M King Group. “If there are ambiguities in the report, or an acceptable standard for the remediation cannot be established, the auditor and the plant quality assurance manager or team should have a meeting. The design/builder can then prioritize the items [and provide] recommendations, budgets and logistical solutions for the remediation.”

“The first step would be prioritizing all the findings from the food safety audit,” says Jim Kinane, senior MEP/process engineer at Fisher & Sons. “Some items may require simple, quick fixes such as repairing a leaking pipe. Fix the simple items right away, then collect cost and timeline information to complete the larger projects.” As auditors typically require a response in 30 days for minor nonconformances and 14 days for a major nonconformance, Kinane suggests putting together an action plan appropriate for the response.

Of course, reviewing the audit is the first step in determining critical issues, along with the impact they may have on the business, says Joe Bove, Stellar, vice president, design. Next, a priority plan should be set based on the issues that pose the highest risk to food safety. The plant owner should share the report with the A&E/C firm and ask for additional input. The auditor and the A&E/C do not need to meet as long as the client fully understands the issues and has a plan to resolve them. A competent A&E/C firm should be able to develop innovative solutions to minimize cost and eliminate the concern, according to Bove.

“The A&E/C firm should prioritize the deficiencies while also analyzing the difficulty [design, constructability, cost] in enacting a solution,” says Paul Tyler, senior vice president—food and beverage division at Haskell. “Naturally, serious health threats need to be addressed immediately and, when possible, in a manner that allows the plant to remain in operation.” The balance of the items should be reviewed holistically so design and construction remediation efforts can be efficiently implemented with the least possible impact on plant operation. The processor should be involved in each step of the design and budgeting process to ensure the corrective actions are funded by and integrated into the plant’s regular operations and shutdowns, according to Tyler.

Some processors take a band-aid approach to fixing a problem instead of taking on a complete repair that may be more costly and negatively affect production schedules. When this is the case, Troy McOmber, vice president, Fisher & Sons, says working with an A&E/C firm can help a processor make an informed decision and set up budgets and construction schedules for a temporary repair, followed by a planned upgrade/complete repair when schedules allow.


Easy or hard fixes

Is a problem/repair/renovation easy or hard, relatively inexpensive or costly? Well, that depends on what it is. “The most common food safety issues in plants are practices such as propping doors open, storing chemicals incorrectly, not washing hands and not wearing proper food safety gear,” says Kinane. These issues are—and can be—the hardest to fix since they require changing behaviors,  which requires continuous training. “Design problems can be easier to correct since once the new design is in place, the problem is fixed,” adds Kinane.

Besides training employees, management must track and report their performance to know who’s been trained and in what areas. “Tracking and reporting help management educate and re-educate their workers at any time, says Jedson’s Brink. When well planned, repairs often can be made with minimal disruption. “Many fixes can be accomplished utilizing temporary partitions and negative air pressure within the workspace during normal work hours or off-shifts, as long as the workers follow plant personnel sanitation protocol,” says AM King’s Jernigan. When this isn’t possible, more extensive logistical plans are necessary. Plus, any repair that can directly impact food safety (air quality, pathogen harborage, etc.) must take top priority and be addressed immediately.

“Standing water on floors is a common, yet manageable, problem,” says Stellar’s Bove. If the floor drains need to be replaced as soon as possible, temporary construction measures will be necessary to ensure food safety. For instance, an “igloo” or temporary walls can be used to encase the rework area. “Typically, when we see floor drain issues, we also see a rough concrete floor,” adds Kinane. “Food safety auditors may give a nonconformity rating because the floor is too difficult to clean.” But replacing the floor isn’t the only option; applying a floor coating over the old floor increases the floor’s strength, cleanability and appearance.

Floor drain issues are often the result of repeatedly clogged drains. One source of the problem is maintenance crews removing the filter baskets because they require frequent cleaning. However, without the baskets, some of the food byproducts may get caught in the trap and eventually result in a backup, says Haskell’s Tyler. “Making sure the baskets are maintained in the floor drains and sinks is essential.”

Air pressurization is another matter. “Issues with air pressurization require a plant-wide study by competent mechanical and refrigeration engineers,” says Bove. These professionals should review existing equipment for capacity requirements, review the floor plan for air gaps (doorways, vents, etc.) and develop a corrective action plan. Installing new ductwork, equipment and building improvements can improve hygienic airflow.

“However, the most difficult improvements to implement are those that require many stakeholders within the same plant to achieve a renovation target,” states Brink. He provides some examples:

  • Sanitation work SSOPs may require hygiene programs to be completed within certain time intervals.
  • Procedures in disassembly and reassembly uncovered in an audit may add time to getting the equipment back into production.
  • A major structural update or renovation may be required when there is not enough lighting to effectively perform duties, a roof leak exists, or air handling systems are found to be inadequate.

Resolving incorrect room temperature can be as simple as conducting maintenance on existing systems or as difficult as upgrading the source providing the chilling, says Bove. Assuming the latter, building and infrastructure modifications may be necessary.

While some repairs may be easy to complete, others may require major renovation. For a rule of thumb in terms of the intensity of repairs/renovations, see the box on pages 69-70.


Planning for renovation

The initial planning stage for renovation should provide a very detailed work plan and a schedule that includes tasks, duration and responsibilities. Designers and engineers should pre-purchase needed materials to eliminate the possibility of construction delays, says Bove. The timeline should include coordinating site activities (such as plant shutdowns, cleanup times and material deliveries) with the operational leadership. The design and construction staff must understand the scope of the work and develop a schedule that allows for tasks to be completed in the allocated time frame.

When possible, renovations should be planned around plant shutdowns (weekends, holidays, maintenance shutdowns or cleanup days), suggests Fisher’s Kinane. In all cases, temporary barriers should be installed to limit dust and other contamination. “When it is not possible to perform a renovation while the plant is down, we recommend creating larger differential room pressures and airflow to lower sanitation zones, in addition to plastic barriers to reduce the risk of contaminating production areas.”

Jedson’s Brink offers a few workarounds if it is necessary to close lines or the entire plant:

  • Transfer production to a sister plant.
  • Build up an inventory of SKUs produced on that line/plant prior to renovation.
  • Move production to another line or provide a redundant or duplicate line to be used during the renovation.
  • Assess the scope of the required modification and its duration or coordinate these with operations to minimize impact to throughput.

Major structural changes in a food plant can be the most difficult work to plan and, according to Jernigan, require some detailed thought. “My experience is that major structural changes can become necessary in facilities that have an exposed steel structure and deal with acids, caustics or high humidity. I recall one facility where all the roof joists needed to be replaced in a particular section of the plant due to severe rust and deterioration. A M King’s team developed a logistics plan that consisted of replacing one joist at a time in the accessible areas; the joists were fabricated in sections for easier installation. The equipment had to be temporarily relocated to allow the major work to be completed, and food-grade temporary walls were erected to section off the work areas.”

“Major structural changes to a plant occur when the structure is no longer capable of isolating the outside environment from the production environment within the plant,” says Brink. “Weather, insects, animals, human and vehicle traffic, and materials of construction that do not meet current sanitary requirements are all threats to your food safety program.” If an improvement or modernization project is necessary to pass an audit, the plant should isolate the food processing areas from the work area or even shut down the processing line while the work is being completed.

A building should be repaired and/or updated to protect the safety of the workers and the viability of the line any time its structural integrity is compromised due to moisture infiltration, excessive loading from collateral equipment or continual exposure to processing elements such as cleaning agents or oil-saturated steam,  says Fisher’s McOmber. Other reasons for a processor to consider changes to a facility are to assure proper worker egress in an emergency or to bring the building up to current seismic and lateral loading codes.

Repairs to a building’s structural systems are inherently tricky and usually involve working over, around and under existing lines. Repairs of this type are generally time consuming, with construction durations dependent on the extent of the work to be accomplished. An A&E/C team with experience working in operating plants can work closely with the processor to quarantine construction areas from production areas and work within plant shutdown periods to accommodate the production schedule, according to McOmber.

“Major structural changes may be necessary when an existing space needs to be converted to RTE, and a walk-on ceiling or interstitial space is required to accommodate process utilities and refrigeration air units,” adds Stellar’s Bove. Steel roof supports also will need to be reinforced to have enough load capacity to support the additional roof loading. During the project, temporary walls must be used to isolate the work and ensure welding smoke and debris do not migrate into the active processing area.


Equipment and automation considerations

Conveyance issues in old plants are more common than in new ones. “Typically, in a facility where poor conveyance routing or faulty equipment is being used, the issues can be resolved by proper reengineering and/or investment in more modern equipment,” says A M King’s Jernigan. However, these situations may require a processor to reevaluate its entire process flow and make changes to the production process. Brink recommends inline or linear flow over serpentine configurations to reduce cross-contamination during both production and sanitation periods. Linear layouts also allow workers to have access to all parts of the line with minimal crossing over and/or under the conveying system. Accumulation tables remove bends in the line, improving the use of floor space.

“Older production equipment represents outdated technology,” says Kinane. “We would evaluate the option of eliminating the equipment and/or combining it with other lines. The benefits include less equipment to clean, better machine utilization and less maintenance. I was in a company with three lines for three different types of product and one conveyor system. More changeovers on the conveyor system were required, but using one conveyor system helped ensure the equipment was structurally sound and operated in a hygienic manner since more maintenance and cleaning time was available.”

With ever-changing technology, equipment is being developed to provide a more food-safe environment. For instance, in the past, equipment was designed with windows made of non-shatter-proof plastics and glass; today’s equipment includes shatter-proof windows and no glass. Plus, lights built into the equipment are designed to be shatter proof, says Kinane.

There’s also help for the ubiquitous floor drain, says Brink. Automated product recovery and reuse systems can address problems with BOD discharge issues in an existing floor drain system. For example, in a bottling operation, dumping product during syrup changes results in high micro and BOD charges, which can be minimized by recovering these products for use at a later time. In addition, properly implemented automation integrates with the three main areas needed to perform a successful cutoff at the end of a bottling operation: the syrup room, filler room and depalletization area.

“The installation of new automation and production equipment often provides the best opportunity to make upgrades to a facility,” says Jernigan. These may include the installation of new mechanical systems, floor drains, lighting and other equipment or structural repairs that will have a significant impact on overall food safety.

“The major benefits of automation are related to production efficiency and food-quality consistency,” adds Haskell’s Tyler.

Automation, however, isn’t a magic pill that cures all renovation ills. “Too often, we expect automation to fix or compensate for mechanical design flaws,” says Boccard’s Fitsch-Mouras, “but if the [building] design is really wrong, even the best automation won’t fix it.” Consequently, building constraints must be factored into any automation design. “I can’t think of any instance where it would be fair to say the automation helped in fixing a building issue.”


For more information:

Christian Fitsch-Mouras, Boccard Life Sciences Inc., 281-269-6020, cfitsch-mouras@boccard.com

Chris Brink, Jedson Engineering, 513-579-3133, chris.brink@jedson.com

Stuart Jernigan, A M King Group, 704-365-3160, sjernigan@amkinggroup.com

Paul Tyler, Haskell, 904-791-4500, paul.tyler@haskell.com

Jim Kinane, Fisher & Sons, 360-757-4094, jmk@fishersons.com

Joe Bove, Stellar, 904-260-2900, jbove@stellar.net

Troy A. McOmber, Fisher & Sons, 360-757-5687, tam@fishersons.com
 

Easy and not-so-easy fixes for your plant


Easiest to fix:

Roof patches—This issue is easy to fix as long as, it does not call for a wholesale replacement that requires roof-top equipment and utilities removal and replacement.

Flat edges—Flat edges hold water, which becomes stagnant and dangerous. Adding sloped tops (and completely filling the voids within) alleviates this problem.

Pipe condensation—This is a simple fix: Remove the insulation and replace it with the appropriate R value. Make sure the right type of insulation (not fiberglass batt) is used, and the correct jacketing is installed.

Peeling floor surfaces—This is a relatively easy fix, presuming the floor surface is not underneath low-clearance equipment. Steps generally include scraping and/or shot blasting the existing surface, installing a self-leveling subsurface and applying a food- and temperature-grade (urethane, epoxy, etc.) floor coating.

Failing sealant—Sealants exposed to washdown are continually displaced, and inspection/replacement should be part of the maintenance protocol.

Inadequate hose stations—Adding hose stations with the required spacing and hose lengths, as well as the proper water temperature, is relatively easy.

Chipping paint—Much like flooring, failing paint must be completely removed and replaced with a washable surface that can withstand cleaning chemicals.

Unsanitary doors—Doors made of non-chemical cleaning-resistant materials, or with water-retaining or microbial harborage points, should be replaced.

Lack of GMP stations—Smock, hand-wash, safety glasses, ear protection and foot-wash stations should be added at all access points to production areas.


Difficult to fix:

Entire roof problems—A full-roof replacement can dislodge dust that will fall into exposed production areas below. Additionally, removal and replacement of roof-mounted HVAC, process equipment and related utilities can be costly and require plant shutdowns.

Voids between wall/structural steel covers and the structural components to which they are attached—Voids behind covers can be harborage areas for microbes. Lack of consistent sealant around these covers can expose production areas to this contamination.

Wall condensation—Wall condensation is generally the result of inadequate wall insulation and vapor barrier, wall penetrations or both. Wall penetrations are relatively easy to seal, but replacement of insulation or installation of a vapor barrier can be costly.

Negative pressure zones—Production areas should be positively pressurized versus non-production areas, and the entire building should be positively pressurized versus the exterior. Outside airflow into production areas introduces outside elements that can jeopardize food safety. Alleviating this problem could be as simple as adjusting airflows of the existing HVAC equipment, but it could also be as difficult as adding demising walls, doors, HVAC equipment and air-pressure control sensors.

Old/unsanitary process and packaging equipment—Advancements in process equipment (materials, valves, fillers, tanks, piping, etc.) and packaging equipment (rollers, belts, baggers, etc.) have led to the potential for a food-safe production area. However, antiquated equipment may have harborage areas that are difficult to access for inspection or cleaning.

Ineffective ceilings—Exposed building structures can accumulate dust and other potential food threats. Certain production areas may require a ceiling, but typical ceiling systems (fiberglass-reinforced plastic [FRP] grid, insulated metal panels [IMPs]) require maintenance. Because ceilings are difficult to access and are directly over processing equipment, maintenance and repairs require close coordination and line shut downs.

Floor drain problems—Floor drains that are not properly trapped, or drain lines that span from non-production areas to production areas, may require replacement. This can be difficult to achieve as it requires concrete slab removal and replacement.

No separation of raw product from finished goods—Dust from raw product can migrate to finished product, resulting in the need for physical separation if it does not already exist. The addition of walls in existing plants can be challenging.

A lack of CIP systems—Older processing facilities may not have clean-in-place (CIP) systems, resulting in the need to periodically disassemble sections of pipe for proper sanitizing. This time-consuming process often results in minimizing or skipping this step in the production process. However, retrofitting CIP systems into an existing system is a complex process.

No COP rooms—Proper clean-out-of-place rooms facilitate the cleaning of food processing containers and equipment while isolating this process and sending the rinse waste directly out of the production areas through the process drain systems. Cleaning this equipment in the production areas can result in food contamination, but new COP room construction can be costly.

No hub drains—Draining waste water from production equipment to hub drains (rather than discharging to the floor and expecting it to slope to nearby drains) is the proper sanitary design. But the addition of hub drains to an existing process waste system requires the removal and replacement of slab sections and possible modifications to the existing underground piping.

Improperly installed pipe and conduit stand-offs—Wall-mounted pipes and conduits should stand off walls several inches to allow for cleaning of the entire pipe and wall surface. If this was not done during the original installation, removing, rerouting and installing the pipes and conduits can be costly.

Using fiberglass-reinforced plastic—If you have considered adding FRP panels to an existing wall or new facility to facilitate cleaning, don’t do it. These panels are mechanically attached or glued to wall surfaces, but sealants eventually fail and microbes are able to grow in the recesses and eventually escape to contaminate food product. Removing these panels and repairing the walls and adjacent utilities can become a difficult task.

Source: Paul Tyler, Haskell.