Good Manufacturing Practices for Flexible Packaging
Converting
FOOD SAFETY MANAGEMENT SYSTEMS
TOM DUNN
FLEXPACKNOLOGY LLC
October19,2016
1GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

How do These Relate to Each Other ?
FOOD SAFETY MANAGEMENT SYSTEM FOOD PACKAGING MANUFACTURING
Bottles
Cans
Bags
Boxes
Trays
Liners
2GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Food safety and packaging
Choking 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 20-Oct-163

Agenda
OBJECTIVE: Clarify obligations and opportunities
POINTS TO COVER
Food safety and good manufacturing practices
Manufacturing food packaging while managing safety
◦Hazard Analysis
◦Good manufacturing practices
Common language of food safety management system
◦Hazard Analysis
◦Risk Assessment
◦Mitigation
Management System Rules
Management System Enforcement
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING ©
2016
20-Oct-164

Food safety
GOOD MANUFACTURING PRACTICES
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING ©
2016
20-Oct-165

From 40,000 feet
FIRSTLY, DO NO HARM OBEY ALL LAWS
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING ©
2016
6

Just like Gravity,
The law is for our own protection
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016 7

Manage safety
WHILE MANUFACTURING FOOD PACKAGING
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING ©
2016
20-Oct-168

10/20/20169 20-Oct-169
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).
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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
20-Oct-1610GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Safe materials (relative to food & to use)
20-Oct-1611GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Suitable purity for packaging;
(the forgotten ingredient)!
Food
Supply
Chain
20-Oct-1612GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Substance
Raw
material
Article
Suitable purity (supply chain integrity)
Food
Supply
Chain
20-Oct-1613GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Use a common language
FOR FOOD SAFETY MANAGEMENT
20-Oct-1614GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Made safely (with a bias toward safety)
“Good manufacturing practice…”
1. Establishment
2. Control of Operations
3. Maintenance & cleaning
4. Hygiene
5. Transportation
6. Product Info & awareness
7. 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)
20-Oct-1615GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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 to
the metal!”
16GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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!
17GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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?
18GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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!
19GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

A bias toward safety: Hazard analysis:
GMP Consideration… Bio Chem Phys Comments
Establishment 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
20-Oct-1620
Assess hazard “receiving resin”
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Good
manufacturin
g 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
21GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Good
manufacturin
g 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
Product
Hazards
GMP’s to mitigate PRPs
Mitigated
product
hazards
22GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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
HACCP
Product
Hazards
Mitigated
product
hazards
Good Mfg
practice
23GOOD 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
product
hazards
Product
Hazards
Mitigated
product
hazards
Good Mfg
practice
Manufacturing
process
20-Oct-1624GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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
20-Oct-1625GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Management system rules
WHICH WAY IS UP?
Contract law model
Command & Control model
20-Oct-1626GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Rules of management systems
COMMAND & CONTROL MODEL CONTRACT LAW MODEL
27GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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
20-Oct-1628GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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”)
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016 20-Oct-1629

GMPs Legislated for Food Packaging
Manufacturing in Europe
EC 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
30GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

GMPs (PRPs) formalized for Food
Packaging Manufacturing
ISO TS22000-4 PAS 223
31GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Contract law model for societal optimum
Economic
System to
deliver
diverse/low
cost goods
to public
Environmental
Material &
energy
efficient
Delivery
system
Social
Reliably
safe &
nutritious
food
Sustainable Business Model
20-Oct-1632GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Retailers: “biggest skin in the game”
Supplier Processor Retailer Consumers
20-Oct-1633GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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
20-Oct-1634GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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
20-Oct-1635GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

10/20/201636 20-Oct-1636
Packaging: liability multiplier
Multi-layer film:
$100 k
Filled packages:
$4 million
Retail packages:
$7 million
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Management systems enforcement
OR ELSE WHAT?
Accountants
SEC
20-Oct-1637GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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 38

Complimentary food safety roles
Safe
food
Supply chain
integrity
Public well
being ($ , )
20-Oct-1639GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Management systems acronyms & terms
1. Scheme owners “benchmark” their system to the GFSI guidelines
1. BRC
2. SQF
3. IFS
4. FSMS 22000
2. “Certifying Bodies” (CB) obtain license to audit to the system
1. Auditors have specific training to the scheme and for auditing activities
2. Auditors have relevant industry experience and/or training
3. Manufactures hire a CB to audit their system
1. “Evidence”: ongoing management of food safety system practices, elements, commitment
2. Much more than housekeeping “inspection” (e.g. AIB inspections)
20-Oct-1640GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

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
20-Oct-1641GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

10/20/201642 20-Oct-1642
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
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016

Thank you!
tdunn@flexpacknology.com
Questions?
Thank You!
GOOD MANUFACTURING PRACTICES FOR FLEXIBLE PACKAGING CONVERTING © 2016 43