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SANITATION ESSENTIALSFOR HUMAN FOOD MANUFACTURING

FDA FSMA Readiness Training

25 Aug 2016

Brenda Stahl, PhDCFSAN/OFS

Division of Plant Products and Beverages

Welcome

Brenda Stahl, CFSAN/OFS Introduction

Joe Stout, Commercial Food Sanitation Industry Perspective

Brenda Stahl, CFSAN/OFSFDA Perspective – PC Rule RequirementsQ&A and Wrap Up

Agenda

• Appreciate the importance of sanitation efficacy, management and verification in the food industry

• Outline the modernized GMP’s requirements regarding

sanitation, including training

• Recognize the necessity for sanitation control

• Describe current industry sanitation practices

Objectives / Overview

Joseph Stout RSPresident Commercial Food Sanitation (CFS)

Sanitation Essentials Industry Perspective

1. The Big Picture

2. Hygienic Design

3. A Risk Based Approach to Design

4. The Process and Science of Cleaning

5. Seven Steps of Cleaning

6. Industry Partnership

FDA Sanitation Essentials

#1 THE BIG PICTURE

Food Safe means food made under target conditions. Zero can be lost in a split second with the wrong decision.

99 % Food Safe 20,000,00099.9% Food Safe 2,000,00099.99% 200,00099.999% 20,00099.9999% 2,00099.99999% 20099.999999% 2099.9999999% 299.99999999% .2

Produce 2 billion portions and Safety Risks

The Risk of Not Being 100% Perfect

Salmonella

Recalls

Listeria Lost Consumer Confidence

Complaints

Regulatory Citations

Special Situations

Illness / Death Lost SalesBuffer Zone

Assuring Food Safety;

Hygienic ZoningSanitation Programs

Environmental MonitoringSanitary Design

TrainingAuditsGMPs

DocumentationShared knowledge

Influences that can push things to the edge;

Change New people w/o knowledgeCommercialization projectsOld Plants / equipmentLimited Investment CapitalLabor cut backs w/o controlsNew products

Expectation

Food Safety

Controls

Food Safety Effective Management at “the Cliff”

Safe food is all aboutPreventive Controls

#6

Pest Control

Zero Resident Pathogens =

#2

GMP Programs

and Execution

#3

Hygienic Design &

Maintenance for

Sanitation

#4

Sanitation Programs

and Execution

#5

Environmental Monitoring

#1

Separation of Raw from

RTE

+ + +++

CFS Preventive Plan for Environmental Pathogen Control & Sanitation Excellence in Food Manufacturing Plants

#2 HYGIENIC DESIGN

© 2016 Commercial Food Sanitation LLC. All rights reserved.

Or sample it

YOU CANNOT CLEAN IT!

You cannot reach it

AND

If you cannot see it

Common Sense Approach to Sanitary Design


A few examples of poor design

Sanitary DesignHard to Clean

Massey, Russell

An investigator who reviewed these 2 stovetop slides had difficulty making the connection to what she sees in food plants. A loarge part of your audience is experienced investigators. Can you find different images?

Sanitary DesignEasy To Clean

Massey, Russell

An investigator who reviewed these 2 stovetop slides had difficulty making the connection to what she sees in food plants. A loarge part of your audience is experienced investigators. Can you find different images?

Classic Sandwich # 1

Picture of equipment

Picture of equipment

This poor design is protected by pasteurization discovered more than 150 years ago.

21

Dissimilar processesShould have physical separation to reduce the risk of cross contamination.

Separate Processes Where Possible

= Pathogen

RAW WAL

L

RTE

Separate Raw from RTE

Massey, Russell

Slide looks fine, However, REMINDER: Your script should emphasize industry perspectives and practices, rather than teaching principles

Non-Traditional Sandwich

Picture of USB and USB Port

There are more than a billion of these connectors in use today. Even if a billion people make this mistake once and lose 1 second correcting the mistake, the lost time = 31 years.

Review — Persistence of Listeria monocytogenes in food industry equipment and premisesBrigitte Carpentier (a), Olivier Cerf (b)a) Laboratory of Food Safety, French Agency for Food, Environmental and Occupational Health Safety (ANSES), Maisons-Alfort, Franceb) Alfort Veterinary School, Maisons-Alfort, France

We conclude by proposing that there are no strains of L.monocytogenes with unique properties that lead to persistence, but harborage sites in food industry premises and equipment where L. monocytogenes can persist.© 2011 Elsevier B.V.

International Journal of Food Microbiology145 (2011) 1–8

Massey, Russell

Suggest move citation info from slide to script. Choose key points and add to slide.

25

1. Cleanable to a microbiological level2. Made of compatible materials3. Accessible for inspection, maintenance, sanitation4. No liquid collection5. Hollow areas hermetically sealed6. No niches7. Sanitary operation performance8. Hygienic design of maintenance enclosures9. Hygienic compatibility with other systems10. Validated cleaning and sanitizing protocols

Principles of Sanitary Design

Massey, Russell

Suggest using one or two words for each bullet on slide


26

#3 A RISK BASED APPROACH TO HYGIENIC DESIGN

Manufacturing Practices • Equipment & Facility design

• Facility maintenance• Roofing maintained

• Employee training• Layout & physical

separation • Condensation control

• Pest Control Programs • Container identification system

• Allergen Management• Traffic patterns

Formula Robustness

Equipment Design & Sanitation Procedures

Infrastructure Design

Manufacturing Practices

Hygiene Practices• Hand washing• Hair/beard restraints• Jewelry restrictions• Personal hygiene

practices • Appropriate

clothing• Designated eating

areas • Housekeeping

responsibilities • Traffic patterns

Balancing Controls with Formulations

Massey, Russell

Unless you're going to talk about each item in left and right columns, I suggest removing and addin to the script and leaving the graphic on the slide

Formula RobustnessEquipment

Design & Sanitation Procedures

Infrastructure Design

Manufacturing Practices

Frequent cleaning

Sanitize hands

Foam Clean walls and ceilings routinely

Positive air & RH controlled

Hurdles at RTE area entrance Maintenance

interventions

Clean equipment & environmental swabs

Periodic Equipment Cleaning / teardowns

Zoning Principles

Tile Floors

Sloped floors & Sanitary Drains

Tile or IMP walls

Coved floor walls junction

Raw RTE separation

Robust training programs

Uniforms and captive footwear

Cultured Dairy Products

Massey, Russell

Unless you're going to talk about each item in left and right columns, I suggest removing and addin to the script and leaving the graphic on the slide


#4 THE PROCESS AND SCIENCE OF CLEANING

Cleaning in a food processing plant = • A proactive activity not a treatment• Protection for public health • Established procedures to control equipment and

environmental conditions to protect food safety and quality. Target:– Unwanted microbial activity– Foreign Material – Chemical contaminants.

Cleaning Defined

Clean offices and rest rooms. Janitorial

Snow removal, pick up leaves in fall.Seasonal

Unscheduled cleaning – a spill of cheese. Non-Routine

Happens when line goes down equipment, facility Routine

Equipment deep cleaning (typically micro sensitive) PEC

Infrastructure cleaning – ceiling, walls, overheads PIC

Classifications of Cleaning

Roofs / Building Exterior

Seasonal Activities

Rest Rooms / Locker Rooms

Offices

Our Focus Today Equipment

Plant Infrastructure

Plant areas to be cleaned

33

What is PIC?

All infrastructure has design flaws which create harborage / wear points for risks including, microbial, foreign material (pests) and chemical contamination prevention.

Due to harborage and wear points, facilities must be routinely inspected, and swabbed (pathogens).

The PIC cleaning (including risk points) should be listed in the MSS, have an SSOP and be scheduled at a frequency to maintain control.

Periodic Infrastructure Cleaning

Massey, Russell

Wordy. Should replace sentences with bullet points

What is PEC?Periodic Equipment Cleaning is a tear down clean for hard to access areas. Equipment must be disassembled beyond what is done during normal routine cleaning.

The PEC task with risk points should be listed in the MSS and scheduled at a frequency to maintain control and eliminate risk. PEC details and frequency should be captured in the equipment SSOP.

What is Routine Cleaning?Cleaning that occurs when lines shut down to proactively prevent microbial, foreign material or chemical contaminants.

Procedures, chemicals and frequency should be captured in the SSOP.

Equipment Cleaning

Massey, Russell

Wordy. Should replace sentences with bullet points

PEC and PIC are work arounds for

poor equipment and facility sanitary design.

Follow the 7 Steps of Cleaning

The use of alcohol (with Quat) with wipers. Waterless

Limited use of water to remove soils and then dried Combination

No water used at all – fully dry clean up Dry

Full wet wash down Wet

How do we clean it?

Massey, Russell

The 7 Steps are mentioned here but defined much later in the slideshow

PECPeriodic Equipment Cleaning


PICPeriodic Infrastructure Cleaning

RoutineDaily Scheduled Cleaning

The Master Sanitation Schedule (MSS) contains• All items to be cleaned. • A reference # for the SSOP to use.• A SSOP should include

– How the is equipment and facility is cleaned– Disassembly / Needed Utensils / Needed Equipment– Frequency of cleaning– The type of cleaning – wet or dry– Chemicals needed. – SSOPs should be guided by the Sanitary Design Checklist

• A monthly report should show % completion of all non-routine cleaning tasks.

Master Sanitation Schedule (PEC, PIC, Routine)

Claudia Baenen

many words

41

Master Sanitation Schedule

#5 THE 7 STEPS OF CLEANING

Massey, Russell

Should this read: The 7 Steps of DRY Cleaning?

Follow the 7 Steps of Dry Cleaning

• Vacuums• Brushes, brooms, shovels, scrapers• Dry towels• Compressed air (Not advised – controlled)• Accessibility

– Scissor lifts– Ladders– Doors, ports

• Dry Ice• Steam Cleaning

DryHow do I clean it?

1. Pre-Sanitation Preparation2. Secure & Dismantle3. Pre-Clean 4. Detail Cleaning5. Final Cleaning6. Sanitation Inspections7. Final Inspection and Documentation

7 Steps of Effective Dry Cleaning


Dry = no H2OHow do I clean it?


Combination of dry and wetHow do I clean it?

Follow the 7 Steps of Wet Cleaning

WetHow do I clean it?


1. Dry Clean2. Pre-rinse3. Soap and Scrub4. Rinse and Inspect5. Assemble6. Pre-Op7. Sanitize

7 Steps of Effective Wet Cleaning


Direct link to poor sanitation

• Inaccessibility • Hollow rollers• Fibrous belting• Bio films • Aerosols• Standing water• Mops / foam squeegees• Standing water • Drain back-ups

Can lead to poor sanitation when not maintained

• High pressure water or air • Re-usable cleaning tools• Congested work area • Bearing • Door seals • Switches

Sanitize & assemble

Post sanitation / pre-op inspection

Prepare for formal inspection

Post rinse & self inspect

Apply detergent & scrub

In sync, top down pre-rinse

Secure, disassemble, dry clean

Enables Effective Sanitation

• GMP’s • Continuous employee training • Dedicated trainers & training tools • Dedicated tool storage• Single use cleaning aides • Synchronized process• Manual scrubbing• Flood sanitizing • Continuous inspection• Flashlights • ATP verification

Step 1

Step 2

Step 3

Step 4

Step 5

Step 6

Step 7

7 Steps of Effective Wet Sanitation One step at a time


Sanitation Process

Sanitation process

A niche area even after washing and sanitizing harbors micro activity


#6 INDUSTRY PARTNERSHIP


• Encourage Hygienic Zoning to separate raw from RTE.

• Imperfect facility or equipment designs should be deep cleaned at a frequency to maintain sanitary conditions.

• Internal GMP audits should be thorough, identify risks and include action plans for remediation.

• Encourage science based education and hands on training. Encourage ongoing training of new and existing employees.

• Do not penalize facilities for finding positives. Encourage to find and eliminate.

• Help educate consumers on the difference between raw and RTE foods and methods to control cross contamination in home kitchens.

Things to promote for Continuous Improvement.The industry needs your partnership.

Massey, Russell

Wordy. Suggest using bullet points for each item

Joseph Stout RS

[email protected](847)881-6212

www.commercialfoodsanitation.com

Industry PerspectiveSanitation Essentials

mailto:[email protected]

http://www.commercialfoodsanitation.com/

Brenda Stahl, PhDCFSAN/OFS

Division of Plant Products and Beverages

FDA PerspectiveSanitation Essentials

• The preventive controls regulation (21 CFR Part 117) is divided into seven subparts:– 1. Subpart A: General Provisions– 2. Subpart B: Current Good Manufacturing Practices– 3. Subpart C: Hazard Analysis and Risk-Based Preventive

Controls– 4. Subpart D: Modified Requirements– 5. Subpart E: Withdrawal of a Qualified Facility Exemption– 6. Subpart F: Requirements Applying to Records That Must

Be Established and Maintained– 7. Subpart G: Supply-Chain Program

21 CFR Part 117 – Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive

Control for Human Food

Massey, Russell

- All slides are extremely wordy; too much for the reader. Suggestions: slides should be used as support for what you want to convey/memory jogger. - Draw a red circle around Subpart B, since that is focus of this slide- Your speaker notes doesn't mention sanitation at all. A connection needs to made between sanitation and this slide

• Clarification that require protection against contamination of food includes protection against allergen cross contact.

• The term “shall” was replaced with the term “must.” • “Manufacturing/processing” is used in place of “manufacturing”

in order to be consistent with the definitions outlined in the Definitions section of Subpart A.

• Certain provisions containing recommendations were deleted. For example, some provisions using the terms “should” or “compliance may be achieved by” are gone.

• Cleaning of non-food contact surfaces at a frequency necessary to ensure protection against contamination of food is now required.

• New requirements for holding and distributing human food by-products intended for use as animal food

Subpart B GMP:110 vs 117

Massey, Russell

Again, very wordy. Suggest leaving only the bolded items and deleting the rest

• Preventive Control: risk-based procedures, practices, and processes that significantly minimize or prevent the hazards identified under the hazard analysis – consistent with the current scientific

understanding of safe food manufacturing

– “Knowledgeable Person” = Training

Definitions

Massey, Russell

Think about eliminating some of the wording and transition to the next slide

• Sanitation Practices: Can be a measure or procedure or activity that reduces or removes a microbial, chemical or physical hazard

– Cleaning: removal of debris and food soils

– Vacuuming

– Clean-in-Place Systems

– Sanitizing: adequately treat cleaned surfaces by a process that is effective in destroying vegetative cells of pathogens, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer.

Definitions

• Sanitation Controls: procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens, biological hazards due to employee handling, and food allergen hazards (§ 117.135(c)(3)).

Definitions

Massey, Russell

Your comments should make a connection to Mr. Stout's slides

• Sanitation controls must include, as appropriate to the facility and the food, procedures, practices, and processes for the:

• (i) Cleanliness of food-contact surfaces, including food-contact surfaces of utensils and equipment;

• (ii) Prevention of allergen cross-contact and cross-contamination from insanitary objects and from personnel to food, food packaging material, and other food-contact surfaces and from raw product to processed product.

Sanitation Controls

• Sanitation Controls:– Do not require validation (Supply Chain Controls, Allergen Controls)

– Can be verified using environmental monitoring• Listeria swabbing in RTE facilities that have determined

Listeria is a hazard that requires control

– Not always directed to critical control points• “Appropriate for Food Safety” (21 CFR part 117.135(a)(ii)

• Preventive Controls can include Sanitation practices as Sanitation Controls, but not all Sanitation practices are Preventive Controls

Definitions

• Preventive controls are based on a hazard analysis performed by the facility

• Example: RTE Facilities– If the facility manufactures an RTE food where

environmental pathogens are a hazard that needs to be controlled, certain cGMP programs elevate to preventive controls.

Preventive Control or cGMP?

• RTE Facilities – Elevated cGMP’s– Sanitation of a specific food contact area

• Utensils that are used directly prior to packaging in RTE foods

– Sanitation of a specific non-food contact area• RTE facility that has a historical concern with Listeria in floor drains

• Based on a hazard analysis of the food and the facility


• Example of Sanitation Controls that can elevate to a preventive control– Use of a common line for different products with

different allergens• Cross Contact/Allergen Control

– Overall sanitation of a facility that manufactures both ready to eat and NRTE products within same manufacturing space


• Failure to maintain buildings, fixtures, other physical facilities in a sanitary condition

• Failure to monitor sanitation conditions and practices with sufficient frequency to assure conformance with cGMPs

• The plant is not constructed to allow adequate cleaning and to be kept in good repair

• Failure to maintain plant equipment and utensils

Ref No Counts Description21 CFR 110.35(a) 2005 Buildings/Sanitation

21 CFR 110.35(c) 1677 Pest21 CFR 110.20(b)

(4) 1384 Floors, walls and ceilings21 CFR 110.20(b)

(7) 1096 Adequate ventilation

21 CFR 110.40(a) 1005 Chemical Contaminant21 CFR 110.10(b)

(6) 714 Effective use of hair restraint21 CFR 110.80(b)

(2) 707 Personal cleanliness21 CFR 110.20(b)

(5) 649 Safety lighting and glass21 CFR 110.80(b)

(7) 618Equipment, containers,

utensils

Top cGMP Violations observed 2014-2016

• 117.4(b)(2): All employees should receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual's assigned duties.

Subpart A (General Provisions): cGMP Training Requirement

Q & A – Use the Adobe Connect pod to type your questions

Brenda Stahl, CFSAN/OFS [email protected]

Questions & Answers

mailto:[email protected]

State Employees:https://www.foodshield.org/blog-training-news/

FDA Employees:http://inside.fda.gov:9003/CFSAN/CFSANStaffCollege/FoodSafetyModernazationAct/ucm449582.htm

FSMA Rule Readiness Training Resources

https://www.foodshield.org/blog-training-news/



http://inside.fda.gov:9003/CFSAN/CFSANStaffCollege/FoodSafetyModernazationAct/ucm449590.htm





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SANITATION ESSENTIALSFOR HUMAN FOOD MANUFACTURING

FDA FSMA Readiness Training

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