World’s Best Sanitation! RLONG AUG 2015

Worlds Best Sanitation!

Worlds Best Sanitation!Food Safety for the Modern World

By: Robert Long

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Developing World Class Food Safety ResultsEstablishing Best in Class Programs

Executing Against Robust Metrics

Establishing Best in Class ProgramsConsiderations as Developing Program

Sanitation / Environmental PracticesEnvironmental Pathogen RisksTraffic PatternsSanitation NeedsMaintenance Factor

Facility / Equipment DesignFacility LayoutFloors ConditionsDesign for Sanitation EffectivenessPersonnelTrainingGMPs ComplianceMaintenance BehaviorsSanitation SkillsDeveloping Culture of Food Safety

Establishing Best in Class Programs

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

HOUSEKEEPING & DAILY CLEANING

Designated Areas (in mfg zones)

Non-Mfg Zones/Areas

Pedestrian Paths/Routes

Process/Packing Daily Cleaning

Contractor Area Daily CleaningCHANGEOVER & 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:Tracking of Cleaning ProcessUtilize Best Practice Sanitation Methods (BPSMs) for most effectiveness- Wet & Dry Clean Create Plant SMEs (Subject Matter Experts)Utensils Tactics:Dedicated usage & storageCleaning & controls plansImproved quality & trackingEstablishing Best in Class Programs

Behind It, Above It, Below It, Among It, Between It, Atop It! BelowAroundBetweenBehindAbove

What we can see and easily reachWhat we missWhat we missCleaning Viewpoint- Line of SightYou can not clean what you can not see!Establishing Best in Class Programs

GMPSFOOD SAFETY

ExclusionandAccessibilityIncoming MaterialsandStorage Practices

CleaningandSanitation

Pest Management

EquipmentandMaintenance

ALL ARE CRITICAL!The Building BlocksEstablishing Best in Class Programs


Know the Four Major Vehicles of Contamination1. 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 OrganizationStored 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 StrategyEstablishing Best in Class Programs

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?FLOORSHAND RAILSOVERHEAD STRUCTURESPRODUCTION EQUIPMENTHVAC DUCTING AND GRILLESEstablishing Best in Class Programs

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 ConcernsPM 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 & PracticesEnvironment & InfrastructureProcess (Time & Temp)Ingredients (Wet & Dry)Sanitation (Dry & Wet)Utensils & ToolsEquipmentFinished ProductEstablishing Best in Class Programs

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:Establishing Best in Class Programs

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:Establishing Best in Class Programs

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, etcPPE vs. GMPEstablishing Best in Class Programs

Conduct a Cleaning Needs AnalysisHACCP/HARPC based risk assessmentHazards (allergens, pathogens, FM, pests)Quality change-over (flavor, color)Knowledge of products / process Is it dry or wet process?

Apply Cleaning Method / FrequencyChoose appropriate cleaning method (dry, wet)Frequency of cleaning

Sanitation SuccessEstablishing Best in Class Programs

Executing Against Robust MetricsApproach: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 Executing Against Robust Metrics

Executing Against Robust MetricsPerform 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.

PEOPLEInfluence Attitudes, Manage Behaviors

Metrics for Worlds 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

PEOPLEExecuting Against Robust Metrics

TELL MESHOW MEWATCH MEFOLLOW UP

TRAINING

Executing Against Robust MetricsEstablish 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 equipments 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

Executing Against Robust MetricsDetermine 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

Executing Against Robust MetricsRevamp 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 companys 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

Executing Against Robust MetricsCost = 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 IMPACTHIGH RISK & HIGH IMPACTLOW RISK & LOW IMPACTLOW RISK & HIGH IMPACTDEFINED: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.) COSTExecuting Against Robust Metrics

Executing Against Robust MetricsOnce 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 MetricsNEOS = No Excuses, Only Solutions!

Executing Against Robust MetricsSanitation Programs: Executive SummaryEFFECTIVE FACILITY & EQUIPMENT CLEANING TACTICS & FREQUENCIESESTABLISHED SANITARY DESIGN STANDARDSEnvironmental Monitoring & Mapping, IPM, FSP, and Sanitation Auditing data trendingESTABLISHED DRAIN CLEANING & DISINFECTANT TREATMENTSWork with employees and vendors, revamp/revise MSS to make More effectiveReview time/cost for accessing cleaned Areas, determine if design changes Save on cost overall (ex- laddersVs. catwalks)PARTNERSHIPS WITH CHEMICAL VENDOR REPS & PEST CONTROL COMPANIESIN DEPTH ANALYSIS OF FACILITY & MICROBIAL HARBORAGE AREAS (ENVIRONMENTAL MAPPING)PARTNERING WITH ALL DEPARTMENTS FOR AN INTEGRATED APPROACHEVALUATING RISKS, IMPLEMENTING IMPROVEMENTS & MONITORING RESULTS

Metrics for Worlds 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 programsExecuting Against Robust Metrics

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:

Executing Against Robust MetricsDrive 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 differencesExecuting Against Robust Metrics

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 testingExecuting Against Robust Metrics

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 treatExecuting Against Robust Metrics

Very Important Point:

Solving something means that the problem does NOT continue to be repeated!


HARPC (FSMA changes measurements):

1- ID Hazards2- Risk-Based Preventive Controls3- Monitoring Effectiveness4- Corrective Actions5- Verification6- Record Keeping & Documentation7- 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.Executing Against Robust Metrics

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.Executing Against Robust Metrics

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.);Executing Against Robust Metrics

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.Executing Against Robust Metrics

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 companys 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.Executing Against Robust Metrics

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 doesnt mean a company shouldnt 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. Executing Against Robust Metrics

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);Executing Against Robust Metrics

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.Executing Against Robust Metrics

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). Executing Against Robust Metrics

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.Executing Against Robust Metrics

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. Executing Against Robust Metrics

REMEMBER The 10 Basics

These are the core factors for all crews to work at:

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 dont 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, Dont Get Bitten ByUtilizing Poor Sanitation Methods Not Verifying/Validating Food Safety ProgramsFailure to Comply With FSMA ExpectationsValue Engineering Out Necessary Equipment & Facility Sanitary Design ImprovementsComplacency and Arrogance of Attitude that This Will Never Happen to Our CompanyDeveloping World Class Food Safety Results

Dont Get Bitten!Developing World Class Food Safety ResultsBe The Predator, And NOT The Prey!

QUESTIONS?

Documents

World’s Best Sanitation! RLONG AUG 2015