hazard analysuis food packaging manufacturing(2)
TRANSCRIPT
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016
Good Manufacturing Practices for Flexible Packaging ConvertingFOOD SAFETY MANAGEMENT SYSTEMS
TOM DUNNFLEXPACKNOLOGY LLC
October19,2016
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How do These Relate to Each Other ?
FOOD SAFETY MANAGEMENT SYSTEM
Say what you do
Do as described
Record as done
Actual vs. Expected
Act on variances
FOOD PACKAGING MANUFACTURING
Bottles Cans Bags Boxes Trays Liners
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016
Food safety and packagingChoking hazard: film wrapper
Nauseating odor: box liner
Illegal chemical: brick box
glass shards: metal-capped jar
Carcinogen: film lamination
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AgendaOBJECTIVE: Clarify obligations and opportunities
POINTS TO COVERFood safety and good manufacturing practicesManufacturing food packaging while managing safety
◦Hazard Analysis◦Good manufacturing practices
Common language of food safety management system◦Hazard Analysis◦Risk Assessment◦Mitigation
Management System RulesManagement System Enforcement
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Food safetyGOOD MANUFACTURING PRACTICES
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From 40,000 feet
FIRSTLY, DO NO HARM OBEY ALL LAWS
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Just like Gravity,The law is for our own protection
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016
Manage safetyWHILE MANUFACTURING FOOD PACKAGING
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It’s the law for: manufacturing food packaging
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)
PART 174 -- INDIRECT FOOD ADDITIVES: GENERAL
Sec. 174.5 General provisions applicable to indirect food additives.
(a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purpose of this part and parts 175, 176, and 177 of this chapter, good manufacturing practice shall be defined to include the following restrictions:
1. The quantity of any food additive substance …shall not exceed an amount not more than reasonably required to accomplish the intended physical or technical effect in the food-contact article…
2. Any substance used as a component of articles that contact food shall be of a purity suitable for its intended use.(b) …[P]rescribing safe conditions for the use of a substance as an article or component of articles that contact food shall not be construed to
relieve such use of the substance or article from compliance with …the Federal Food, Drug, and Cosmetic Act. (1) …[If a] regulated food-packaging material were found on appropriate test to impart odor or taste to a specific food product such
as to render it unfit …, the regulation would not be construed to relieve such use from compliance with section 402(a)(3).
Food safety management for manufacturing food packaging
Safe Materials◦ Compositionally fit for use:
◦ Food type◦ Use Conditions
Safely made◦ Good manufacturing
practice (gmp)
Suitable purity◦ RM supplier GMP◦ Internal storage/handling
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Safe materials (relative to food & to use)
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Package (Container)
Suitable purity for packaging;(the forgotten ingredient)!
FoodSupplyChain
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Package (Container)Substance
Raw material
Article
Suitable purity (supply chain integrity)
FoodSupplyChain
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Use a common languageFOR FOOD SAFETY MANAGEMENT
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Made safely (with a bias toward safety)
“Good manufacturing practice…”
1. Establishment2. Control of Operations3. Maintenance & cleaning4. Hygiene5. Transportation6. Product Info & awareness7. Training
GMPs-whether drug manufacture, food processing, food contact materials
◦ All have same basic structure◦ Details depend!◦ What is being manufactured?◦ Hazard assessment◦ Risk analysis◦ “Prerequisite programs (PRPs)
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Supply Chain safety threatened by common language“Good manufacturing practices”• Basic structure: stays the same• Details: relative to product
manufactured• Compare to ‘speed limit”
“Pedal tothe metal!”
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Supply Chain safety threatened by common language“Good manufacturing practices”• Basic structure: stays the same• Details: relative to product
manufactured• Compare to ‘speed limit”
Conditioned on location and time!
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Supply Chain safety threatened by common language“Good manufacturing practices”• Basic structure: stays the same• Details: relative to product
manufactured• Compare to ‘speed limit”
Ambiguous?
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Supply Chain safety threatened by common language“Good manufacturing practices”• Basic structure: stays the same• Details: relative to product
manufactured• Compare to ‘speed limit”
Conditioned on location!
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016
A bias toward safety: Hazard analysis:
GMP Consideration… Bio Chem Phys CommentsEstablishment 1. Biological: Plastic extrusion temperatures
exceed sterilization levels of food borne pathogens.
2. Chemical: Identified, stored and allocated to production according to specifications for use.
3. Physical: Harmful physical contaminates also represent extrusion equipment hazards and are filtered out of polymer stream.
Control of Operations
Maintenance & cleaning
Hygiene
Transportation
Product Info/awareness
Training
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Assess hazard “receiving resin”
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Good manufacturing practices
• Basic structure: stays the same• Details: relative to product• Safety hazards to Product?
• Practice(s) mitigate risks?
• Reduce frequency that risk occurs
• Reduce severity when one occurs
GMPs to “Prerequisite Programs”
PRPs to mitigate risk
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Good manufacturing practices
• Basic structure: stays the same• Details: relative to product• Safety hazards to Product?
• Practice(s) mitigate risks?
• Reduce frequency that risk occurs
• Reduce severity of an occurrence
GMPs to “Prerequisite Programs”
Manufacturing process
ProductHazards
GMP’s to mitigate PRPsMitigated product hazards
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Manufacturing process
HA◦ Hazard Analysis
◦ Biological hazards◦ Chemical hazards◦ Physical hazards
◦ Do GMPs satisfactorily mitigate hazard?
CCP◦ Remaining hazard = unacceptable risk?◦ Critical Control Point
Control limits Monitoring procedure Corrective action Verification Recordkeeping
HACCPProductHazards
Mitigated product hazards
Good Mfg practice
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016
HACCP HA
◦ Hazard Analysis◦ Biological hazards◦ Chemical hazards◦ Physical hazards
◦ Do GMPs satisfactorily mitigate hazard?
CCP◦ Remaining hazard = unacceptable risk?◦ Critical Control Point
Control limits Monitoring procedure Corrective action Verification Recordkeeping
Unmitigated producthazards
ProductHazards
Mitigated product hazards
Good Mfg practice
Manufacturing process
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Incoming resin hazards SAFETY HAZARD CATEGORY
Biological?
Chemical?
Physical?
GMP INDICATED?
Pathogens killed at extrusion temperatures. *
Regulatory composition
Contaminates filtered out at screen pack* Good hygiene practices still needed following extrusion
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Management system rules
WHICH WAY IS UP?
CONTRACT LAW MODEL Command & Control model
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Rules of management systemsCOMMAND & CONTROL MODEL CONTRACT LAW MODEL
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Command & control vs. Contract models
Hippocratic Oath Firstly, do no harm What is the positive this does? …Prevents food borne illness and related disease
Global Food Safety Initiative Reduce food safety risks with equivalence and convergence among effective FMSs.
Manage global food system cost: eliminate redundancy and improve operational efficiency
Provide international stakeholder platform for collaboration, knowledge exchange & networking
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Global Food Safety Initiative A program of The Consumer Goods Forum (Paris)
◦ GOVERNANCE: major global retailers, manufacturers and food service operators◦ VISION: “Safe food for consumers everywhere”.◦ MISSION: to provide continuous improvement in food safety management systems
to ensure confidence in the delivery of safe food to consumers worldwide◦ METHOD: Technical working groups develop and maintain “Guidelines” in order to
determine equivalency between FSMSs (“Benchmarking”)
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GMPs Legislated for Food Packaging Manufacturing in
EuropeEC NO. 2023/2006 REQUIREMENTS
Ensure that manufacturing operations carried out with:
1. A Quality Assurance System(QAS) (organized/documented arrangements made with the purpose of ensuring quality to conform to rules & Standards)
2. A Quality control System (Systematic application of measures within QAS that ensure compliance of starting materials and finished articles with QAS
3. Specified documentation
4. Compliance with detailed riles on printing inks and recycled material
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GMPs (PRPs) formalized for Food Packaging Manufacturing
ISO TS22000-4 PAS 223
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Contract law model for societal optimum
Public health
Supply chain integrity
Econ
omic
System to deliver diverse/low cost goods to public
Envi
ronm
enta
l
Material & energy efficient Delivery system
Soci
al
Reliably safe & nutritious food
Sustainable Business Model
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Retailers: “biggest skin in the game”
Supplier Processor Retailer Consumers
Value Added
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Elements of food safety costs Failure
◦ Falls short of specification◦ Internal: before delivery◦ External: after delivery
Appraisal◦ Product testing◦ Quality control
Prevention◦ Compliance capability◦ Investment
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Examples of safety costs Failure
◦ Internal◦ Down-grade◦ Re-work◦ Re-inspect
◦ External◦ Handle complaints◦ Manage recalls◦ Lose goodwill
Appraisal ◦ Inspect
◦ Raw material◦ Work in process
◦ Measure◦ Equipment capital◦ calibration
Prevention◦ Train◦ Maintain preventatively ◦ Houseclean◦ Operate capable process in
control
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Packaging: liability multiplier
70 x Value AddedMulti-layer film:$100 k
Filled packages:$4 million
Retail packages:$7 million
Management systems enforcement
OR ELSE WHAT?
ACCOUNTANTS SEC
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Management systems enforcement
SECURITIES AND EXCHANGE COMMISSION
Roles◦ protect investors◦ maintain fair, orderly, & efficient markets◦ facilitate capital formation.
CERTIFIED PUBLIC ACCOUNTANTS
Roles◦ accounting◦ auditing◦ financial reporting◦ internal controls ◦ legal compliance.
GOOD MANUFACURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016
Complimentary food safety roles
FDA FSMS Auditor
Safefood
Supply chain integrity
Public well being ($ , )
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Management systems acronyms & terms
1. Scheme owners “benchmark” their system to the GFSI guidelines1. BRC2. SQF3. IFS4. FSMS 22000
2. “Certifying Bodies” (CB) obtain license to audit to the system1. Auditors have specific training to the scheme and for auditing activities2. Auditors have relevant industry experience and/or training
3. Manufactures hire a CB to audit their system1. “Evidence”: ongoing management of food safety system practices, elements, commitment2. Much more than housekeeping “inspection” (e.g. AIB inspections)
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Management systems expectations
One world. One standard, One annual audit Employee awareness of role in food supply chain Lower safety costs from failure and appraisal events Higher probability of distributing low/no risk product to market Fewer market recalls
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Conclusions
Public Health
Supply chain
integrity
Societal Optimum
Food packaging can pose risks to food
Command & control model has limits $takes can be high Contract and command /control models complement each other
Contract model continuous improvement
3rd party certification financial audit
Align organization toward food safety
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Thank [email protected]
m Questions?
Thank You!
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016