Case Study: Sanitary Design. Justin Kerr

Transcription

1 Case Study: Sanitary Design Justin Kerr

2 Sanitary Design - Cost or Investment? Case Histories Zones 4,3,2 and 1 Presented By Justin Kerr Factor IV Solutions, LLC. Listeria Control Work Shop Yuma, AZ

3 SANITARY DESIGN FAILURE = PROFIT LOSS POOR DESIGN CONTRIBUTES TO A FAILURE LOST PRODUCTION INCREASED SANITATION LABOR INCREASED CHEMICAL SPENDING INCREASED ENVIRONMENTAL TESTING CUSTOMER DISUCSSIONS REGULATORY PRESSURES

4 Listeria Case History Zone 4 Loading Dock Waste Room

5 Zone 4 Problems Auxiliary waste room was used for product waste only few days per week. Had multiple flooring surface types Drains had quat rings, however not on regular cleaning schedule. Pallet jacks and employees entered and exited with out floor treatment or sanitizer.

6 Search and Destroy Frozen pastry waste on the process floor in plastic waste bags for entire shift. Floors had repeating EMP positives in processing Product was removed when sanitation and pre-op was complete. Using a Quadrant/sectioned EMP map able to identify path between dock and processing room. Positive on pallet jack and waste room floor & drains in auxiliary room were enough to escalate

7 Corrective Actions: Waste Room Auxiliary waste room was deep cleaned and flooring was replaced with new. Alcohol boot spray sanitizer was placed in hallway from waste room to production Floor foamer was placed at entry to production room Barrier FS Paste was used for sealing wall seams and identifying drain water activity Waste was removed every shift from Production Employee training included: 1. Pallet Jacks SSOP 2. Drain SSOP 3. Employee GMP s 4. Foot Sanitizer SSOP 5. Doorway Sanitizer PPM Log 6. Powdered Floor Treatment Trial

8 Defining Deep Clean What are the surface types to be cleaned? Soft metals Plastics Stainless Painted surfaces Overhead Concrete Wood What are the soil types to be removed? Mechanical Grease/Lubricant Rubber Tire Debris Organic accumulation In-Organic accumulation Mildew/Mold growth

9 Defining Deep Clean (cont.) Mechanical or Physical Action Brushes, do we need to replace? Boosted or high pressure is 99% of the time a bad idea for corrective action cleaning. Access to areas and control of the lifts, fork trucks and ladders used, don t need to have those carry risk elsewhere. What can we change from standard process? Our job in corrective action is to eradicate, not just stunt organism growth. If the standard process is Chlorinated alkaline detergent followed by Quat sanitize, what chemistry additions can be made. Example Alkaline Rinse Acid Rinse Sanitize high ppm Rinse Sanitize no rinse

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11 Foot Sanitizer and SSOP for care

12 Floor Cleaning & Transport Equipment Risk Assessment was completed and the designation of equipment to areas and replacement of some equipment prevented use in multiple areas. How do we clean the floor scrubbers? Where do you clean the pallet jacks? These were all questions we had to revisit.

13 Listeria Case History Zone 3 Painted Wall

14 Zone 3 - Problems Wall adjacent to packing line was painted annually in off-season. Drain that ran parallel to the wall was know for Listeria positives Drain was always a part of the corrective actions and negatives were achieved. Then the swab rotation was followed and the drain would go for long periods with out swab verification. Search and Destroy was not a part of the listeria swab program.

15 Search and Destroy While cleaning the wall small blisters of paint were discovered. Using a sharp edge blade a puncture was made and layers were peeled off and swabbed. POSTIVE ON ALL THREE. Black growth was behind each layer, years of repainting had trapped the listeria and other organisms in the blisters. Hose rack on the wall and employee practices had likely lead to the spreading of Listeria as it wept out of the wall to the floor.

16 Solutions and Corrective Actions: Painted Wall Lines were shut down Area was sealed off from the rest of the plant. Wall Area was heated Not safe Light sanding of walls and then heavy sanding. Cleaning and sanitizing included Fogging and Cl02 Wash down. Recoated walls with Durable epoxy coating. Employee training included 1. Hose Nozzles off the ground 2. Scheduling of repairs 3. Swab Rotations and Failure Corrective actions 4. Frequency of swabbing areas

17 Listeria Case History Zone 2 Equipment Structure

18 Zone 2 Problems Packing conveyor leg was a hollow plastic footing. The structure lead all the way to the base of a conveyor. Product positives in line study were all post processing but before sealed. Packing room floor positives. No Zone 2 or 1 swabs

19 Search and Destroy Floor positives lead swabbing to the legs of the conveyor, and side guides of the conveyor structure. Inspection of the inside of the plastic legs showed organism growth and no listeria swabs were completed legs were replaced.

20 Listeria Case History Zone 1 Chiller

21 Frozen Product Tests Positive Listeria Spp. Only previous positive for company had been a drain near a chiller No other indications of control being lost on sanitation or GMP s. With the product positive the line shuts down, Sanitation goes into full corrective action cleaning Alkaline Wash Acid Wash Specialty Sanitizers ( Sterilex, ClO2, Quat) Corrective action cleaning is verified with swabs, all yield negatives post sanitation Zones 1, 2 and 3. Line starts back up after negatives, increase facility and product testing implemented

22 SSOP Verifications looked Good

23 Environmental Monitoring Zone 2 Chiller Footing Swab

24 Environmental swabs start to show a problem 2 in-process swabs had tested positive on a floor drain next to the chiller over a short period, however all post sanitation swabs are clean. With no desire to have problem Line is shut down. Because of the in-process Zone 3 positives the following areas are 1. GMP s are reviewed, boots are swabbed, maintenance tools are swabbed, 2. Floor sanitizer powder is added to increase control of traffic patterns. 3. Barrier FS paste is placed around footings to prevent product and water from accumulating in voids. 4. Sanitizer Foggers are running at end of pre-op in freezers, 5. Sterilex Re-circulations and applications 6. Cl02 equipment re-circulations and rinses 7. Ladders are thrown away, sanitation foamers are swabbed.all negatives A lot of product on hold or not produced due to production down time. Time for a line study>>>>>

25 Samples Post Blanch Negative Samples On Transfer Conveyors Negative Samples on Flume Negative Samples at Freezer in feed Negative Samples at Freezer out let Negative As well as, drain positives are being compared to product positives to verify if we are dealing with transient or a now resident listeria. Line Study in Summary Listeria Spp..Negative

26 Supervisor Visual inspection finds the source Just around the edge of a riser there would be black specs when the rinsed the chiller down. The risers were stainless cylinders with threaded bolts running through the cylinders. They were swabbed, of the 3 swabbed, 2 were positive Listeria Spp. The Listeria Spp. source was a collection of hollow risers.

27 Design changes were made to allow better access to the base of the chiller when cleaning and defrosting

28 Falling film chiller modification Positives were a match to the drain and product Threads + Sandwich Joint + expansion and contraction

29 Design Investment became an expensive Bucket Full of Positives 7 days of down production Over 50 Listeria Spp. Tests Countless ATP and APC tests Sanitation Overtime Abundant Chemicals Consumed 4x Normal Tools and supplies replaced Tools thrown away 24 days since first positive Isolates confirmed Drain, Product & Bolts were a match.

30 Summary Training like today has to make it back to the facilities. How are you training your employees to design, clean and maintain equipment and facilities? The managers all knew where Listeria liked to hide in all 4 case histories and with all fairness they are all working 12+ hours a day on many other safety and quality items. On the chiller We ASSUMED that the modification supported cleaning and sanitizing how the modification was completed is what hurt. Stainless angles were inserted to replace the hollow risers. Sanitary design is an investment, not a cost.

31 Is anybody Cost Pooling Correction or Corrective Actions Dollars? (and Yes I know the plants not running when we are cleaning) Employee Chemicals Utility Utensils Verification Hourly Wage Detergent Cooling Scrub Pads QA wage Taxes & Ins. Sanitizer Water Electrical Cover liners ATP swabs Scheduled work time Regular & OT Pay Drum Pumps Electrical Hoses/ Nozzles Environmental Swabs Scheduled Training time Secondary Containment COD & BOD Scrub brushes. Squeegees, Shovels PCQI Data Review & Trending Time Unforeseen OT Pay Dispensing Equipment Service Contracts Lift Truck Trash Liners EMP Review PPE Freight Waste water Neutralization Corrective Action Training time Specialty Equipment (Dry Ice) Test Kits/Test Strips Scissor lifts Buckets, Jugs or containers SSOP Review MSS Sanitation Review

32 Cost of EMP failure - Let s Assume 2 Sanitation Employees, 1 QA employee and 1 PCQI (+/- $565.00) Employee Chemicals Utility Utensils Verification Hourly Wage Taxes & Ins. Scheduled work time Regular & OT Pay Detergent $40.00 Sanitizer $20.00 Cooling Water Scrub Pads $7.00 Electrical Cover liners $12.00 Drum Pumps Electrical Hoses/ Nozzles $50.00 QA employee OT $35 ATP swabs $14.00 Environmental Swabs $90 Scheduled Training time Secondary Containment COD & BOD Scrub brushes. Squeegees, Shovels $48.00 PCQI Data Review & Trending Time (priceless) Unforeseen OT Pay 2 hours = $45.00 Dispensing Equipment Service Contracts Lift Truck Trash Liners EMP Review (priceless) PPE $12.00 Freight $80 Waste water Neutralization Specialty Equipment (Dry Ice) SSOP Review (priceless) Corrective Action Training time $100 Test Kits/Test Strips $10.00 Scissor lifts Buckets, Jugs or containers MSS Sanitation Review (priceless)