Hazard analysuis food packaging manufacturing(2)

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


Food safety and packagingChoking hazard: film wrapper

Nauseating odor: box liner

Illegal chemical: brick box

glass shards: metal-capped jar

Carcinogen: film lamination

GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016 May 2, 20233

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


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


Manage safetyWHILE MANUFACTURING FOOD PACKAGING


10/20/20169 May 2, 20239GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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

May 2, 202310GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Safe materials (relative to food & to use)


Package (Container)

Suitable purity for packaging;(the forgotten ingredient)!

FoodSupplyChain


Package (Container)Substance

Raw material

Article

Suitable purity (supply chain integrity)

FoodSupplyChain


Use a common languageFOR FOOD SAFETY MANAGEMENT


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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Conditioned on location and time!


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Ambiguous?


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Conditioned on location!


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

May 2, 202320

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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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


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



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


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


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


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


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


Retailers: “biggest skin in the game”

Supplier Processor Retailer Consumers

Value Added


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


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



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 ($ , )


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)


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



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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m Questions?

Thank You!
