Download Joe Stout, Commercial Food Sanitation

SANITATION ESSENTIALS
FOR HUMAN FOOD
MANUFACTURING
FDA FSMA Readiness Training
25 Aug 2016
Welcome
Brenda Stahl, PhD
CFSAN/OFS
Division of Plant Products and Beverages
Agenda
Brenda Stahl, CFSAN/OFS
 Introduction
Joe Stout, Commercial Food Sanitation
 Industry Perspective
Brenda Stahl, CFSAN/OFS
FDA Perspective – PC Rule Requirements
Q&A and Wrap Up
Objectives / Overview
• 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
Sanitation Essentials
Industry Perspective
Joseph Stout RS
President Commercial Food Sanitation (CFS)
FDA Sanitation Essentials
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
#1 THE BIG PICTURE
The Risk of Not Being 100% Perfect
Produce 2 billion portions and Safety Risks
99 % Food Safe
99.9% Food Safe
99.99%
99.999%
99.9999%
99.99999%
99.999999%
99.9999999%
99.99999999%
20,000,000
2,000,000
200,000
20,000
2,000
200
20
2
.2
Food Safe means food made under target conditions.
Zero can be lost in a split second with the wrong decision.
Food Safety
Effective Management at “the Cliff”
Influences that can push things to the edge;
Change
New people w/o knowledge
Commercialization projects
Old Plants / equipment
Limited Investment Capital
Labor cut backs w/o controls
New products
Expectation
Food
Safety
Controls
Assuring Food Safety;
Hygienic Zoning
Sanitation Programs
Environmental Monitoring
Sanitary Design
Training
Audits
GMPs
Documentation
Shared knowledge
Listeria
Buffer
Zone
Lost Consumer
Confidence
Regulatory
Salmonella
Citations
Illness / Death Lost Sales
Special Situations
Complaints
Recalls
Safe food is all about
Preventive Controls
CFS Preventive Plan for Environmental
Pathogen Control & Sanitation Excellence in
Food Manufacturing Plants
#1
#2
Separation
of Raw from
RTE
#3
GMP
Programs
and
Execution
+
Hygienic
Design &
+
for
Sanitation
+
Pest
Control
Environmental
Monitoring
Sanitation
Programs
and
Execution
Maintenance
#6
#5
#4
+
= Zero Resident Pathogens
+
#2 HYGIENIC DESIGN
Common Sense Approach to Sanitary
Design
If you cannot see it
AND
You cannot reach it
YOU CANNOT CLEAN IT!
Or sample it
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
A few examples of
poor design
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
Sanitary Design
Hard to Clean
Sanitary Design
Easy To Clean
This poor
design is
protected by
pasteurization
discovered
more than 150
years ago.
Separate Raw from RTE
Separate Processes Where Possible
RAW
WALL
= Pathogen
RTE
Dissimilar processes
Should have physical
separation to reduce
the risk of cross
contamination.
21
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.
International Journal of Food
Microbiology
145 (2011) 1–8
Review — Persistence of Listeria monocytogenes in food industry
equipment and premises
Brigitte Carpentier (a), Olivier Cerf (b)
a) Laboratory of Food Safety, French Agency for Food, Environmental and
Occupational Health Safety (ANSES), Maisons-Alfort, France
b) 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.
Principles of Sanitary Design
1.
Cleanable to a microbiological level
2.
Made of compatible materials
3.
Accessible for inspection, maintenance, sanitation
4.
No liquid collection
5.
Hollow areas hermetically sealed
6.
No niches
7.
Sanitary operation performance
8.
Hygienic design of maintenance enclosures
9.
Hygienic compatibility with other systems
10.
Validated cleaning and sanitizing protocols
25
#3 A RISK BASED APPROACH
TO HYGIENIC DESIGN
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
26
Balancing Controls with Formulations
Hygiene Practices
Manufacturing Practices
• Hand washing
• Equipment & Facility design
• Hair/beard restraints
• Jewelry restrictions
• Personal hygiene
practices
• Appropriate
clothing
• Designated eating
areas
Formula
Robustness
Equipment Design
& Sanitation
Procedures
• Facility maintenance
Infrastructure
Design
Manufacturing
Practices
• Roofing maintained
• Employee training
• Layout & physical
separation
• Condensation control
• Pest Control Programs
• Housekeeping
responsibilities
• Container identification system
• Traffic patterns
• Traffic patterns
• Allergen Management
Cultured Dairy Products
Frequent
cleaning
Periodic Equipment
Cleaning / teardowns
Clean equipment &
environmental swabs
Sanitize hands
Foam Clean walls and
ceilings routinely
Equipment
Design &
Sanitation
Procedures
Coved floor walls
junction
Formula
Robustness
Infrastructure
Design
Manufacturing
Practices
Tile Floors
Raw RTE
separation
Positive air & RH
controlled
Sloped floors &
Sanitary Drains
Uniforms and
captive footwear
Hurdles at RTE area
entrance
Tile or IMP walls
Robust training
programs
Zoning Principles
Maintenance
interventions
#4 THE PROCESS AND
SCIENCE OF CLEANING
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
Cleaning Defined
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.
Classifications of Cleaning
PIC
Infrastructure cleaning – ceiling, walls, overheads
PEC
Equipment deep cleaning (typically micro sensitive)
Routine
Happens when line goes down equipment, facility
Non-Routine
Unscheduled cleaning – a spill of cheese.
Seasonal
Snow removal, pick up leaves in fall.
Janitorial
Clean offices and rest rooms.
Plant areas to be cleaned
Plant Infrastructure
Equipment
Offices
Rest Rooms / Locker Rooms
Seasonal Activities
Roofs / Building Exterior
Our Focus
Today
Periodic Infrastructure Cleaning
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.
33
Equipment Cleaning
What is Routine Cleaning?
What is PEC?
Cleaning that occurs when
lines shut down to proactively
prevent microbial, foreign
material or chemical
contaminants.
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.
Procedures, chemicals and
frequency should be captured
in the SSOP.
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.
PEC and PIC
are work arounds for
poor equipment and facility
sanitary design.
How do we clean it?
Wet
Full wet wash down
Dry
No water used at all – fully dry clean up
Combination
Waterless
Limited use of water to remove soils and then dried
The use of alcohol (with Quat) with wipers.
Follow the 7 Steps of Cleaning
Periodic Equipment
Cleaning
PEC
Periodic Infrastructure
Cleaning
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
PIC
Daily Scheduled Cleaning
Routine
Master Sanitation Schedule
(PEC, PIC, Routine)
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
41
#5 THE 7 STEPS OF CLEANING
How do I clean it?
Dry
•
•
•
•
•
Vacuums
Brushes, brooms, shovels, scrapers
Dry towels
Compressed air (Not advised – controlled)
Accessibility
– Scissor lifts
– Ladders
– Doors, ports
• Dry Ice
• Steam Cleaning
Follow the 7 Steps of Dry Cleaning
7 Steps of Effective Dry Cleaning
1.
2.
3.
4.
5.
6.
7.
Pre-Sanitation Preparation
Secure & Dismantle
Pre-Clean
Detail Cleaning
Final Cleaning
Sanitation Inspections
Final Inspection and Documentation
How do I clean it?
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
Dry = no H2O
How do I clean it?
Combination of dry and wet
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
How do I clean it?
Wet
Follow the 7 Steps of Wet Cleaning
7 Steps of Effective Wet Cleaning
1.
2.
3.
4.
5.
6.
7.
Dry Clean
Pre-rinse
Soap and Scrub
Rinse and Inspect
Assemble
Pre-Op
Sanitize
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
7 Steps of Effective Wet Sanitation
One step at a time
Enables Effective Sanitation
•
•
•
•
•
•
•
•
•
•
•
Step 7
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
Sanitize & assemble
Step 6
Post sanitation / pre-op inspection
Step 5
Prepare for formal inspection
Step 4
Post rinse & self inspect
Step 3
Apply detergent & scrub
Step 2
In sync, top down pre-rinse
Step 1
Secure, disassemble, dry clean
Can lead to poor sanitation
when not maintained
•
•
•
•
•
•
High pressure water or air
Re-usable cleaning tools
Congested work area
Bearing
Door seals
Switches
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
Direct link to poor sanitation
•
•
•
•
•
•
•
•
•
Inaccessibility
Hollow rollers
Fibrous belting
Bio films
Aerosols
Standing water
Mops / foam squeegees
Standing water
Drain back-ups
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
A niche area even after
washing and sanitizing
harbors micro activity
#6 INDUSTRY PARTNERSHIP
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
Things to promote for Continuous Improvement.
The industry needs your 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.
© 2016 Commercial Food Sanitation LLC.
All rights reserved.
Sanitation Essentials
Industry Perspective
Joseph Stout RS
[email protected]
(847)881-6212
www.commercialfoodsanitation.com
Sanitation Essentials
FDA Perspective
Brenda Stahl, PhD
CFSAN/OFS
Division of Plant Products and Beverages
21 CFR Part 117 – Current Good Manufacturing
Practice, Hazard Analysis, and Risk-based Preventive
Control for Human Food
• 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
Subpart B GMP:110 vs 117
• 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
Definitions
• 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
• 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)).
Sanitation Controls
• 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 foodcontact surfaces of utensils and equipment;
• (ii) Prevention of allergen cross-contact and crosscontamination from insanitary objects and from
personnel to food, food packaging material, and other
food-contact surfaces and from raw product to
processed product.
Definitions
• 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
Preventive Control or cGMP?
• 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
Preventive Control or cGMP?
• 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
Top cGMP Violations observed
2014-2016
Ref No
Counts
Description
21 CFR 110.35(a)
2005
Buildings/Sanitation
21 CFR 110.35(c)
21 CFR
110.20(b)(4)
21 CFR
110.20(b)(7)
1677
Pest
1384
Floors, walls and ceilings
1096
Adequate ventilation
21 CFR 110.40(a)
21 CFR
110.10(b)(6)
21 CFR
110.80(b)(2)
21 CFR
110.20(b)(5)
21 CFR
110.80(b)(7)
1005
Chemical Contaminant
714
Effective use of hair restraint
707
Personal cleanliness
649
Safety lighting and glass
Equipment, containers,
utensils
618
• 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
Subpart A (General Provisions): cGMP
Training Requirement
• 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.
Questions & Answers
Brenda Stahl, CFSAN/OFS
[email protected]
Q & A – Use the Adobe Connect pod to type your questions
FSMA Rule Readiness Training
Resources
FDA Employees:
http://inside.fda.gov:9003/CFS
AN/CFSANStaffCollege/FoodS
afetyModernazationAct/ucm449
582.htm
State Employees:
https://www.foodshield.org/bl
og-training-news/
Feedback
To submit a question about FSMA, visit
www.fda.gov/fsma and go to Contact Us
Registered participants will receive an evaluation survey in two days.
THANK YOU FOR ATTENDING
FSMA TRAINING
SANITATION ESSENTIALS
FOR HUMAN FOOD
MANUFACTURING
FDA FSMA Readiness Training