World’s Best Sanitation! RLONG AUG 2015

World’s Best Sanitation!
Food Safety for the Modern World
By: Robert Long

Developing World Class Food
Safety Results
Establishing Best in Class Programs
Executing Against Robust Metrics

Considerations as Developing Program
Sanitation /
Environmental
Practices
• Environmental
Pathogen Risks
• Traffic Patterns
• Sanitation Needs
• Maintenance Factor
Facility /
Equipment Design
• Facility Layout
• Floors Conditions
• Design for
Sanitation
Effectiveness
Personnel
Training
• GMPs Compliance
• Maintenance
Behaviors
• Sanitation Skills
• Developing Culture
of Food Safety

Zone 4
Locker
rooms,
halls,
cafeteria
Zone 3
Walls,
floors,
drains,
fork lifts,
hand
trucks,
phones
Zone 2
Exterior of
equipment,
chill units,
framework,
equipment
housing
Zone 1
Product Contact
Surfaces: e.g.
slicers, conveyors,
vats, shredders,
utensils, racks, work
tables, employee
hands
Sanitary Zones In Plan

HOUSEKEEPING & DAILY
CLEANING
Designated Areas (in mfg
zones)
Non-Mfg Zones/Areas
Pedestrian Paths/Routes
Process/Packing Daily
Cleaning
Contractor Area Daily
Cleaning
CHANGEOVER &
INTERVENTION CLEANING
Food/Product Processing
Changeovers
Packing Product/Size or
Customer Changeovers
Reuse Systems Cleaning
Maintenance Intervention
Cleaning
Project Work & Idle Equipment
Cleaning
MASTER FACILITY &
EQUIPMENT CLEANING
Mfg./Non-Mfg. Room Cleaning
Drain Cleaning
Portable Equipment &
Storage Cleaning
Electrical Cleaning
HVAC/Air Handling Cleaning
Sanitation Core Pillar Sanitation Core Pillar Sanitation Core Pillar
MSS TRACKING

Key Tactical Approaches to Execute for Effectiveness:
• Sanitation Tactics:
1. Tracking of Cleaning
Process
2. Utilize Best Practice
Sanitation Methods
(BPSMs) for most
effectiveness- Wet &
Dry Clean
3. Create Plant SMEs
(Subject Matter Experts)
• Utensils Tactics:
1. Dedicated usage &
storage
2. Cleaning & controls
plans
3. Improved quality &
tracking

What we
can see
and easily
reach
What we
miss
What we
miss
Cleaning Viewpoint- Line of Sight
You can not
clean what you
can not see!

GMP’S
FOOD SAFETY
Exclusion
and
Accessibility
Incoming Materials
and
Storage Practices
Cleaning
and
Sanitation
Pest
Management
Equipment
and
Maintenance
ALL ARE CRITICAL!
The Building Blocks

Know the Four Major
Vehicles of Contamination
1. Air
2. Water
3. Surfaces
4. People
Program Goals: To
prevent growth of
microbial spores that can
include both mold and
bacteria.
To prevent insect
development.
To protect the quality of
our products from
process related issues
that result from not
running a clean system.

5S Tool Organization
∙ Stored and Sorted by function
and color.
∙ Stored to match labeled position
dedicated for specific utensil.
∙ Stored clean and ready for re-
use.
∙ Stored in good condition and
maintained as such.

Facility Monitoring & Response- Utilize Risk Management; Change
Practices to Improve Effectiveness and Increase Success. Measure
Using Environmental Mapping Program. Response to findings must be
immediate and intensive, searching out root cause of microbial
harborage and eliminate.
Cleaning Utensils- Standard Set of Tools Should be Established;
Measure Using Audit Results, Self Monitoring Checklists. Response to
Non-compliance findings must be immediate.
Facility & Equipment Cleaning- Use Hard Data to Set Up Proper
Frequencies; Change Practices to Improve Effectiveness and Increase
Success. Measure Using Audit Results, Self Monitoring Checklists,
and Microbial Activity. Response to Non-compliance findings must be
immediate.
Risk Management Strategy

SANITATION Evaluation Example
EVALUATE CREATE EXECUTE DOCUMENT
FLOORS
CLEANED?
HAND RAILS
CLEANED?
PRODUCTION
EQUIPMENT
CLEANED?
HVAC SYSTEMS
CLEANED?
OVERHEADS
CLEANED ?
How & Where DO
you document the
cleaning that was
performed?
How DO you
show the
established
cleaning
procedure was
followed?
How DO you
know personnel
performing the
cleaning was
trained/qualified?
How DO you track
the effectiveness
of the cleaning?
FLOORS
HAND
RAILS
OVERHEAD STRUCTURES
PRODUCTION
EQUIPMENTHVAC DUCTING AND GRILLES

Equipment & Facility Design
• How accessible is the equipment for
cleaning?
• Can the design be changed to improve
the clean-ability of it?
• What tools or methods should be used?
• Does it mitigate pest or micro
harborage?
• Is it on a PM Program?

Preventive & Responsive Maintenance
• Cleaning Access-ability vs. Safety
Concerns
• PM of equipment to prevent failures that
can cause oil/grease leaks, metal
fatigue/broken pieces, and/or other foreign
matter getting into the food stream.
• Responding to failures and repairing
problems, as well as cleaning tools and
parts used.
• Redesign of equipment to improve
functionality and/or access-ability for
maintaining it in a food sanitary state.
• Cleaning your tools.

Troubleshooting for Micro-contamination
People &
Practices
Environment &
Infrastructure
Process (Time &
Temp)
Ingredients
(Wet & Dry)
Sanitation (Dry & Wet)Utensils &
Tools
Equipment
Finished
Product

Any Process Changes or Failures?
Any Ingredient Changes/Bad Lots?
Any Equipment Changes?
Any Utensils or Tools Broken/Dirty?
Any Infrastructure Failures/Issues?
Any Environmental Findings/Concerns?
Any Personnel Changes/New Patterns?
Any GMP Violations/Poor Practices?
Any Micro Sampling Contamination?
Ask About:

Any Maintenance PMs Performed?
Any Sanitation PM Teardowns Done?
Any Equipment Failures/WO Repairs?
Any Contractor or Vendor Work Done?
Any Supplier or Ingredient Changes?
Any Use of Product Rework In Process?
Any Utilities Contamination?
(Comp. Air, HVAC, Water, Steam, etc.)
Any CIP/COP Contamination or Failure?
Ask About:

PPE = Personal Protective
Equipment
PPE = is there to protect YOU!
Examples = Safety Eyewear,
Earplugs, Protective Toed
Shoes, LOTO, Forklift Training,
Confined Space Entry
Requirements, etc…
GMP = Good Manufacturing
Practices
GMP = is there to protect the
PRODUCT!
Examples = Hairnets, Shoe
Covers, Clean Hands,
Designated Hygiene Zones,
Equipment Cleaning, Pest
Prevention, etc…
PPE vs. GMP

Conduct a Cleaning Needs Analysis
HACCP/HARPC based risk assessment
Hazards (allergens, pathogens, FM, pests)
Quality change-over (flavor, color)
Knowledge of products / process
Is it dry or wet process?
Apply Cleaning Method / Frequency
Choose appropriate cleaning method (dry, wet)
Frequency of cleaning
Sanitation Success

Approach:
Look at BIG 3: People, Place, & Process.
People- skills set, training, and behavior.
Place- Cleaning tools, CIP/COP/DIP/DOP
equipment condition/capabilities. (Clean/Dry –
In/Out of - Place)
Process- How clean, what clean, and how tracked.
Also- How do you make it cost-effective?
The Goal: Robust Sanitation Program

Perform full review of current personnel and create
spreadsheet with current qualifications for both
operating and cleaning the different production
equipment.
Evaluate the cleaning ritual and process.
Perform time motion studies to evaluate true labor
hours needed to perform various key cleaning tasks.
Determined gaps from this evaluation to help plan
next steps.
PEOPLE
“Influence Attitudes, Manage Behaviors”

Metrics for World’s Best Sanitation Program:
Must Provide Employees With All 3:
1- TIME – the proper amount of TIME to
perform the requested or expected TASK;
2- TOOLS – the proper TOOLS in order to
perform the requested or expected TASK;
3- TRAINING – the proper TRAINING in order
to perform the requested or expected TASK.
Then Hold Responsible & Accountable for Actions
PEOPLE
TELL
ME
SHOW
ME
WATCH
ME
FOLLOW
UP
TRAINING

Establish a coded utensils program (5S Style) with focus on
Utensil Management/Maintenance Practices.
Work with maintenance department to repair or correct/install any
extra cleaning equipment where cleaning occurs.
Work with chemical suppliers’ CIP Engineer and internal
maintenance resources to identify gaps in the cleaning
equipment’s capabilities, including pumps, piping, sizing, tanks,
chemical delivery process, and software and hardware controllers.
Develop and prioritize list and begin tasking items for repairs or
improvements. This includes creating a validation SOP and
performing time studies on equipment and circuits.
PLACE

Determine costs for internal personnel to perform cleaning
tasks (total cost including benefits), and compare to cost
associated with straight contracted labor force needs.
If utilizing internal employees, and operation runs 24/7,
MUST push to have dual qualified labor force that can
clean and operate equipment so you do not have
double/wasted staffing for independent tasks. This saves
the overtime costs. (Could be a cultural change).
Perform detailed breakdown inspections of equipment and
piping to determine daily, weekly, monthly, quarterly, and
yearly cleaning frequencies needed to insure a successful
MSP.
From this process, create frequencies for equipment and
rooms and add into SOPs. Add SOPs for any areas where
there was no existing SOP to detail cleaning needs to
move away from “tribal” knowledge and improve
consistency of clean ups.
PROCESS

Revamp all SOPs and create a standard format for
them, which includes a header section and picture of
the equipment referenced in that SOP.
Correlate the sign off documentation and checklists to
correspond to these procedures so there is a consistent
process flow from SOP, training and training sign offs,
cleaning performed, and cleaning sign offs.
If internal system, company manages this process.
If contractors utilized, the contracted resource owns
managing this process, but the company’s internal
document controls must link back to this system as well
for closing the loop on what your risk management
process is.
Now you have a base-line to perform a Cost Analysis.
PROCESS

Cost = what resources will it take to implement and
maintain a robust sanitation program?
Evaluate from straight employee program (Internal), straight
contractor program (External), and a combination program
(Synergy) approach.
Internal = all equipment and infrastructure cleaning is
performed solely by full time company personnel. Can be
dedicated resources or flex resources that move from task
to task, whether operational or sanitary.
External = all equipment and infrastructure cleaning is
performed solely by full time contracted personnel.
Company personnel only operate equipment for production.
Synergy = (most typical) = all equipment (product path) is
cleaned by company personnel, and all infrastructure
cleaning (overheads, walls, floors, break areas,
warehouses, MCC Rooms, etc.) are cleaned by contracted
personnel.
Cost Assessment

HIGH RISK &
LOW IMPACT
HIGH RISK &
HIGH IMPACT
LOW RISK &
LOW IMPACT
LOW RISK &
HIGH IMPACT
DEFINED:
RISK = CHANCE OF OCCURRENCE.
IMPACT = COST OF OCCURRENCE.
Prioritize by
chance and cost
to justify per risk
mitigation. Then
can choose to
address the
worst spots first,
and work way
down the list.
HIGHEST RISK +
HIGHEST
IMPACT IF
OCCURS
(IMPACT = cost of
reactive
correction, or
product loss/cost,
or liability impact
or cost).
CHANCE (VS.) COST

• Once you have a full evaluation of PEOPLE-PLACE-PROCESS
and have determined Sanitation Execution Approach, as well
as insured the Facility Management and Hourly Employees are
clear on the Expectations, you can close the loop by
establishing some Metrics to evaluate the success or failure of
the Strategy and be prepared to make adjustments as
challenges arise.
• Metrics can include the following:
- Scope of Work requirements with vendors.
- Microbiological monitoring for cleanliness levels.
- Verification of Systems and Training of People records.
- Facility & Products Risk Assessment against Program.
- Internal Audits of Programs & Processes.
- Continuous Improvement & Validations
Evaluation Metrics
NEOS = No Excuses, Only Solutions!

Sanitation Programs: Executive Summary
EFFECTIVE FACILITY
& EQUIPMENT
CLEANING TACTICS &
FREQUENCIES
ESTABLISHED
SANITARY DESIGN
STANDARDS
Environmental Monitoring &
Mapping, IPM, FSP,
and Sanitation Auditing data trending
ESTABLISHED DRAIN
CLEANING &
DISINFECTANT
TREATMENTS
Work with employees and vendors,
revamp/revise MSS to make
More effective
Review time/cost for accessing cleaned
Areas, determine if design changes
Save on cost overall (ex- ladders
Vs. catwalks)
PARTNERSHIPS WITH
CHEMICAL VENDOR
REPS & PEST CONTROL
COMPANIES
IN DEPTH ANALYSIS OF FACILITY &
MICROBIAL HARBORAGE AREAS
(ENVIRONMENTAL MAPPING)
PARTNERING WITH ALL
DEPARTMENTS FOR AN INTEGRATED
APPROACH
EVALUATING RISKS,
IMPLEMENTING
IMPROVEMENTS &
MONITORING
RESULTS

Metrics for World’s Best Sanitation:
1- EFFECTIVE – results driven
a- microbial testing
b- finished product testing
c- regulatory compliance
2- EFFICIENT – maximum utilization of resources (people and
equipment)
a- turnaround times
b- labor costs
3- EFFORTLESS – sustainable execution ingrained and a habit
vs. forced process
a- program audits
b- compliance to programs

Sanitation Measures:
1- Cost of Chemistry (cleaning chemistry, extra
equipment costs)
2- Cost of Labor (sanitation labor)
3- Microbial Results (post-sanitation swabs and ATP)
4- Late Start Ups/Extra Downtime (costs due to
re-cleans/poor cleans)
5- Teardown/Visual Inspections (% clean, pass/fail)
6- Plant/Employee Engagement (observed, surveys)
7- Employee Knowledge/Skill-sets (testing, observed,
time-motion studies

The 4M Approach:
1- Man: Building the Team
2- Machine: Having the Right Technical
Resources
3- Material: Having the Right Raw Materials
4- Method: Setting and Adhering to the Right
Operating Standards

The 4M Approach:
Drive positive culture change toward individual
accountability and the pursuit of excellence by
putting the right people in the right places and give
them the right direction, then let them do their jobs.
Outstanding business results naturally follow.

Product –Plan- People- Process –Place:
Product = if control Plan, People, Process, Place
Plan = How get there, utilization and execution,
people and process
People = Training/Leadership
Process = Equipment/Flow
Place = Plant to Plant differences

Other Factors:
Quality- Policies, Procedures, Practices
Verify/Validate – assure programs and processes are
functioning as designed/expected
Best Practices - Wet Clean, Dry Clean, CIP/COP, Drain
Clean
Pathogen Control Programs - Pathogen
Environmental Monitoring, post-sanitation testing

Other Factors:
Individual Training – Teaching, developing SMEs
Team -Collaboration/Execution, Team Cleaning
Communication- top down, bottom up, peer to peer
Accountability – Top 3 sanitation issues per facility
Water/Impact and Future- incoming, WWTP, effluent,
COW, city/well, and costs to treat

Very Important Point:
Solving something means that the
problem does NOT continue to be
repeated!

HARPC (FSMA changes measurements):
1- ID Hazards
2- Risk-Based Preventive Controls
3- Monitoring Effectiveness
4- Corrective Actions
5- Verification
6- Record Keeping & Documentation
7- Requirement to Re-Analyze

Customer Audits and Mitigation Decisions Matrix
As plants continue to improve their sanitation programs, in
order to meet the ongoing stricter requirements being mandated
by FDA, USDA, customers, consumers, and corporate entities,
each facility must evaluate plant conditions, microbial data,
inspection results, QA Audit results, and available capital in order
to best decide how to move forward in resolving issues or
improving conditions or processes.
Solutions may have to incorporate both short and long term
corrections, to allow for adequate food safety while the
budgeting and planning takes place for a more permanent fix.

Decision Matrix- How to Choose to mitigate customer
requirements/concerns in processes/facilities:
1- Can meet those expectations through physical infrastructure
changes, which may require cap-ex to cover cost;
2- Can meet those expectations through procedure and policy
changes and train to those changes to enforce compliance;
3- Can meet those expectations through current existing
programs and practices and push back to customers that the
current mitigation steps are adequate.

The way to reach which avenue to pursue is by:
1- Evaluate the finding/audited concern from the customer and
rank its' seriousness and priority to determine if should
address it;
2- Review current policy, practice, process, and infrastructure to
determine if it mitigates that noted risk effectively enough or if
changes are needed;
3- Consider options, along with the cost vs. chance/risk of each
option for developing, designing, implementing, & executing;
4- Select the one (or multiple) options believed best mitigates
the noted risk/concern while remaining as cost effective as
possible;
5- Communicate the necessary proposed changes, along with
gaining approval for any components as required (i.e, from
cap-ex, from corporate QA/QE, etc.);

The way to reach which avenue to pursue is by: (cont.):
6- Develop and execute those changes, along with metrics that
can determine if truly is effectively mitigating the risk
identified, and track it/trend it;
7- Close the loop by saving the proof of concept
documentation/metric tracking, OR revisit if not effective to
determine next steps needed;
8- Assure changes and new approaches are all captured in
policy/practice, and if required, in the PM system;
9- Provide the updated approaches/policies/processes/mitigation
programs to the customer for review and agreement;
10- Communicate up/down our own internal supply chain and
sister plants so any key learning can be shared for cross-
company implementation as needed.

Bottom line, all companies are guilty of "Value Engineering" out
critical components in initial construction and planning phases
on projects because they say "we will do it later as business
increases" but then they never do until they face a catastrophe,
and this is generally the same for MOST companies. This is
why changing the understanding of Food Safety and Sanitation
has to occur within a company’s culture in order to support the
necessary expenses for sustaining a solid program.
For example, a plant might be designed superbly for producing
cheese products, but then their dry side whey department starts
marketing ingredients to an infant formula company and all of a
sudden their facility is “inadequate” to meet those stricter
standards, and these are the types of challenges companies
face as they strive to grow their market share to remain
competitive and profitable.

Again, this points back towards the established
culture/expectation, and how food safety and sanitation is
perceived by the company.
Is it a cost or a first step in overall production?
Is it factored into end product pricing accordingly?
This doesn’t mean a company shouldn’t constantly
evaluate their programs for cost savings and efficiency
improvements, it just means this review has to be a
holistic one balanced against the importance of
sustainability of a robust and proven food safety strategy
and program.

Auditing Sanitation Systems at Plants
Review and Verify Plant has a Master Sanitation Schedule
with further components/programs that cover all of the
following items/components:
- daily housekeeping items;
- product shut down or change over clean ups, or foreign
material/emergency shut down and cleaning;
- down day/deep dive cleaning tasks, with minimum
frequencies indicated;
- SSOPs/WIs that denote processes and procedures
(sometimes plants create, sometimes Hydrite/Ecolab
provides);
- sign off and tracking that cleaning has been successfully
performed with any deviations noted (with supervisor
sign offs for checking document completion);

Auditing Sanitation Systems at Plants
- annual verifications on CIP/COP system cleaning
efficacy (done in tandem with chemical vendors and
plant);
- microbial/pathogen/indicator swabbing documentation
and trending to validate sanitation efficacy;
- training records that indicate employees trained to
SSOPs/WIs that are performing said cleaning tasks and
who are signing off on the MSS documentation;
- Verification of legal records such as chart recorders for
CIP/COP, or Vigilistics/Data Logger recording software
database;
- and then observe an equipment tear down for
verification of cleanliness if/as needed.

So 2 Key Questions:
1- Does your solution mitigate the existing
risk/problem?
2- Does your solution create new risk/problem?
Furthermore:
The key things that we must continue to focus
on and task will be Quality, Efficiency, Safety,
and Training (QEST).

QEST:
For Quality, our challenges include revamping the Sanitation
SOPs, improving our testing procedures on products and
materials, performing more equipment breakdown inspections,
completing redesigns as needed for proper sanitation purposes,
and a CIP project install.
For Efficiency, our challenges are better start-ups and
shutdowns, faster changeovers, less waste, and line speeds that
maximize equipment productivity.

QEST:
For Safety, our challenges are key system improvements,
better auditing programs, more associate awareness, and
improved follow through on concerns.
For Training, our challenges will be focused around
developing and instituting Operational Checklists and
Expectations, Training Qualification Grids, SSOPs, and then
resource the associates with the tools, training, and time in
order to perform their given tasks.

REMEMBER The 10 Basics
These are the core factors for all crews to work at:
1) Cover the Basics: conduct the training, record the
documentation, and be clear on the expectations.
2) Start-ups: work at every room, every day.
3) Quality Output: Cases don’t count if they are not sold.
4) Safety: Nothing you do is worth getting hurt.
5) Effectiveness: Not about time, but about effort.
6) Communication: Be brief, be blunt, be gone.
7) Development: Push people to help themselves.
8) Challenge: Must ask WHY if were not successful.
9) Attitude: Believe it can happen, find ways to get it done.
10) Teamwork: Hold each other to a standard of excellence!
Developing World Class Food Safety Results

In Summary, Don’t Get Bitten By…
Utilizing Poor Sanitation Methods…
Not Verifying/Validating Food Safety Programs…
Failure to Comply With FSMA Expectations…
“Value Engineering” Out Necessary Equipment &
Facility Sanitary Design Improvements…
Complacency and Arrogance of Attitude that
“This Will Never Happen to Our Company”…

Be The Predator, And NOT The Prey!

World’s Best Sanitation! RLONG AUG 2015

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