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Root Cause Analysis:Risk-Based Approach To Prevent Food Safety FailuresMarch 2017

Preventive vs. reactive• Required by Food Safety Modernization Act

Avoids adverse impacts• Recalls, regulatory action, criminal investigation, food safety complaints, etc.

Prioritizes corrective/preventive action response• Severity and likelihood

Provides for continuous improvementAre you doing this now? How do we prioritize?

Why Risk-Based Approach?

ASQ Risk Based Approach (ISO-9001)

5th Annual FDA Reportable Food Registry

Do you make a High-Risk Product?

Analyze and prioritize risk• Define acceptable vs. unacceptable

Develop plans to mitigate risk• Prevent and/or correct

Implement plan• Check effectiveness• Establish continuous improvement through

Plan-Do-Check & Act

Applying a Risk-Based Approach

Any program or process step that prevents:• Undeclared allergens• Allergen cross-contact• Pathogens contamination from:

Environmental Operations Personnel Other

What Processes Present the Most Risk?

What presents the most risk for a recall at your facility?

Polling Question

o Undeclared allergenso Environmental contamination with Listeria or Salmonellao Foreign material contaminationHow would you rate your effectiveness?o Goodo Bado Needs improvement

Root Cause• A factor that caused a non-conformance and should be permanently eliminated through process improvement.Root Cause Analysis• A collective term that describes a wide range of approaches, tools, and techniques to uncover causes of problems.

Root Cause Analysis – What is it?

ASQ Quality Glossary

Cause-Focused Brainstorming

Investigation

The Weed Analogy

Root Cause Analysis – What is it?

Problem• Stone exterior was deterioratingTreating the Symptom• Replacing the deteriorated stone and painting over it

The Lincoln Memorial

Why is the stone deteriorating?• Using high-power sprayers every 2 weeksWhy are we doing high-powered washings every 2 weeks?• Removing bird droppings

Experiment with nettingWhy are there so many birds?• They are feeding on the spiders

Fun Example: The Lincoln Memorial

• Why are there so many spiders?• They are feeding on the insects• Why are there so many insects?• First building in the area to have its lights turned on each evening

The Lincoln Memorial

PROBLEM:Stone exterior was deterioratingSOLUTION:Turn on the lights 30 minutes later than other buildings in the area

5 Why’s

Fishbone Diagram

Root Cause Analysis ToolsWhy

WhyWhy

WhyWhy

5 Why’s• Simple• Not fixed at “5”• Push beyond superficial solutions

Root Cause Analysis Tools

WhyWhy

WhyWhy

Why

PROBLEM:There are drain flies along the cake lineWhy are there drain flies along the cake line?• They are feeding on the waste from the cake lineWhy are they feeding on the waste from the cake line?• The waste is fermentingWhy is the waste fermenting?• It is sitting in the waste containers until the next Down DayWhy is it sitting in the waste containers until the next Down Day?• No one has been assigned responsibility for emptying the waste containers at the end of each shift

Root Cause Analysis Tools – 5 Why’s

PROBLEM:There is an unprotected bulb in a product zone.Why is there an unprotected bulb in a product zone?• It was installed by MaintenanceWhy did Maintenance install an unprotected bulb in a product zone?• The bulbs in inventory were unprotectedWhy were there unprotected bulbs in inventory?• The packing list for the bulbs indicated that they were protected and the receiving clerk did not confirm that the bulbs were, in fact, coatedWhy didn’t the receiving clerk confirm that the bulbs were protected?• The clerk was not trained to confirm that non-food materials received were correct/ matched the packing listWhy wasn’t the receiving clerk trained to confirm the accuracy of incoming goods (other than food)?• It’s not part of the Receiving procedures

Root Cause Analysis Tools – 5 Why’s

Fishbone DiagramRoot Cause Analysis Tools

Equipment Process People

Materials Environment Measurement

Fishbone Diagram – Samples onlyRoot Cause Analysis Tools

Equipment Process PeopleProduction EquipmentMeasurement ToolsComputersSanitation EquipmentHigh Speed DoorsMaintenance ToolsForklifts ScoopsBoilerHVAC

Cleaning ProceduresFood Safety PlanWork InstructionsQA ProceduresMaint. ProceduresReceiving ProceduresFIFO / FEFOPM ScheduleMaster Sanitation Schedule

Line OperatorQA TechnicianSanitation LeadMaintenance SupervisorHR ManagerReceiving ClerkContractorsTemp employeesPest Control OperatorBulk Delivery Driver

Fishbone Diagram – Samples onlyRoot Cause Analysis Tools

Materials MeasurementEnvironmentIngredientsPackagingProcessing AidsReworkWIPFinished Goods

Time LocationShift ChangeProduct ChangeoverLevel of CleanlinessAbrasive Chemicals

Temperature ChecksWeight ChecksMetal Detector ChecksMoisture Checks

Fishbone Diagram

Materials MeasurementEnvironment

Equipment Process People

Obsolete packaging in WH caused inventory overload; which blocked trap #14

EFFECT:Decomposing rodent found in trap #14

Construction has begun on empty field next to the plant

Contractors working on new X-ray installation were leaving doors propped open

Seeing symptoms and not systems

Thinking of the cause as singular

Finding fault with people, rather than the process

Common Pitfalls

Seeing symptoms and not systemsCommon Pitfalls

Drain fly activity in the production area Metal wear in a pump Unidentified items in the Hold area

Production left waste in the area at the end of the shift, expecting Sanitation to remove it

Maintenance is supposed to reassemble equipment, but Sanitation did it

Production put the materials in the hold area and expected QA to mark them

Responsibilities are not clearly identified

Thinking of the cause as singularNon-conformance: • A can of household insecticide is found in the maintenance shop

Common Pitfalls

Causes• Standing water on the grounds (broken sprinkler)• Damaged dumpster is leaking product• Air curtains on doors are turned off• Contracted PCO is not addressing it • Lack of “pest sighting” communication with PCO• Lack of awareness of chemical control program

Common PitfallsFinding fault with people, rather than the processRe-training is not a solution!Changing the training program MIGHT be a solution.Make it easy for your employees to succeed.Make it hard for your employees to fail.

Summary• Risk-based approach• Group brainstorming • Investigation (on the floor)• Go beyond the superficial• Focus on processes, not people

Root Cause Analysis

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