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Cold Chain Management
Systems &Tools
April 10, 2014
Is Quality in a Cold Chain different
from Quality in a generic Supply
Chain?
Why is a Middle East Cold Chain
different from a text book Cold
Chain?
Is a Cold Chain QMS radically
different from any other
manufacturing or ambient QMS?
Points of Difference
 Middle East cold chain are much more costlier due to
temperature extremes
 Middle East cold chains are at “standardization infancy”
due to regulations / checks being built
 Qualification & Validation are terms still misunderstood
and frequently deemed interchangeable
 In a cold chain QMS, the lynch pin is monitoring of
distribution which will bring us close to Validation
Let’s Define
Qualification is where we establish through documented
testing that a process will deliver on an agreed acceptance
standard.
Validation is done when a process is being tested to deliver
on required criteria in highly controlled conditions
Key Words: documented, highly controlled, consistency
Case in Point
Manufacturing environments are usually highly controlled so
by definition can be Validated
Distribution on the other hand is by design a dependent and
variable environment which you can therefore only
Qualify
 Extend of Consequence needs to get enough thought
 In most cases Quality related consequences reach far
beyond the obvious
1) Quality Oversight must extend beyond
manufacturing with same rigor
2) QMS is very important but equally important is
mutual understanding with regulators
3) Enough technical knowhow of your products is
critical to prove quality in your chain
4) Qualification parameters must be interfaced
with manufacturing to enable agility
5) Inflexible and long cold chains run the risk of
“pile up” if quality requirements change
 Optimization of in market
stocks vs. cold chain length
 Documented qualification of
traceability
 Product design to assume
some break in cold chain
SWOT
Quality Strategy
 Countries in ME are still
working to align standards
 Operating in some ME markets
is already a challenge
 Cost of Quality compliance is
usually not considered major
 Third party intermediaries add
to the length of cold chain
 Remain abreast as authorities
release new versions
 Build a buffer in on-going cost
of quality budgets
 Partner with authorities at the
time of market entry
 Maintain active liaison with
major third party QA experts
Governance
o Compliance to market quality standards responsibility
should be shared with local partner
o Some level of access to local regulators is important even
if a third part is involved in the process
o Exercising control over the product until it reaches the
consumer is crucial to prove
o Quality “roadblocks” should be included as part of the
Business Continuity Plan
o Document every link of your cold chain!
Counter-intuition
“The normal human response to the effects
inefficiency is to introduce delay in an attempt to
increase certainty which simply makes the
situation worse - effective distribution design can
be counter intuitive”
Tools Available
 Cool Chain Quality Indicator (CCQI)¹
 GL Certification²
 Good Cold Chain Management Practices (GCCMP)³
 Hazard Analysis & Critical Points (HACCP) Approach
 CQ ,OQ, PQ textbook approach to Qualification
1 – Patent Cool Chain Association
2 – Germanischer Lloyd SE
3 – Refernce Good Transport Practices (GTP) & Good Storage Practices (GSP)
More Tools
 VMI / SMI / JIT
 Kanban to achieve JIT (mfg)
 iLog for Design of your SC
 inFlow, Inventoria, Stock it Easy for
inventory management
 GT Nexus for In Transit Info
 Slingshot, Forecast Pro, Epicore, JDA for
demand forecasting
Questions?
Acknowledgments
Cranfield University
Accenture
Kellogg School of Management
Procter & Gamble Ltd.
AFRIS. AsianFoodRegulationInformationService.
We have the largest database of Asian food regulations in the world and it’s
FREE to use.
We publish a range of communication services, list a very large number of
food events and online educational webinars and continue to grow our Digital
Library.
We look forward to hearing from you soon!
www.asianfoodreg.com
adrienna@asianfoodreg.com

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Cold Chain Management

  • 1. Cold Chain Management Systems &Tools April 10, 2014
  • 2. Is Quality in a Cold Chain different from Quality in a generic Supply Chain?
  • 3. Why is a Middle East Cold Chain different from a text book Cold Chain?
  • 4. Is a Cold Chain QMS radically different from any other manufacturing or ambient QMS?
  • 5. Points of Difference  Middle East cold chain are much more costlier due to temperature extremes  Middle East cold chains are at “standardization infancy” due to regulations / checks being built  Qualification & Validation are terms still misunderstood and frequently deemed interchangeable  In a cold chain QMS, the lynch pin is monitoring of distribution which will bring us close to Validation
  • 6. Let’s Define Qualification is where we establish through documented testing that a process will deliver on an agreed acceptance standard. Validation is done when a process is being tested to deliver on required criteria in highly controlled conditions Key Words: documented, highly controlled, consistency
  • 7. Case in Point Manufacturing environments are usually highly controlled so by definition can be Validated Distribution on the other hand is by design a dependent and variable environment which you can therefore only Qualify
  • 8.  Extend of Consequence needs to get enough thought  In most cases Quality related consequences reach far beyond the obvious
  • 9. 1) Quality Oversight must extend beyond manufacturing with same rigor 2) QMS is very important but equally important is mutual understanding with regulators 3) Enough technical knowhow of your products is critical to prove quality in your chain 4) Qualification parameters must be interfaced with manufacturing to enable agility 5) Inflexible and long cold chains run the risk of “pile up” if quality requirements change
  • 10.  Optimization of in market stocks vs. cold chain length  Documented qualification of traceability  Product design to assume some break in cold chain SWOT Quality Strategy  Countries in ME are still working to align standards  Operating in some ME markets is already a challenge  Cost of Quality compliance is usually not considered major  Third party intermediaries add to the length of cold chain  Remain abreast as authorities release new versions  Build a buffer in on-going cost of quality budgets  Partner with authorities at the time of market entry  Maintain active liaison with major third party QA experts
  • 11. Governance o Compliance to market quality standards responsibility should be shared with local partner o Some level of access to local regulators is important even if a third part is involved in the process o Exercising control over the product until it reaches the consumer is crucial to prove o Quality “roadblocks” should be included as part of the Business Continuity Plan o Document every link of your cold chain!
  • 12. Counter-intuition “The normal human response to the effects inefficiency is to introduce delay in an attempt to increase certainty which simply makes the situation worse - effective distribution design can be counter intuitive”
  • 13. Tools Available  Cool Chain Quality Indicator (CCQI)¹  GL Certification²  Good Cold Chain Management Practices (GCCMP)³  Hazard Analysis & Critical Points (HACCP) Approach  CQ ,OQ, PQ textbook approach to Qualification 1 – Patent Cool Chain Association 2 – Germanischer Lloyd SE 3 – Refernce Good Transport Practices (GTP) & Good Storage Practices (GSP)
  • 14. More Tools  VMI / SMI / JIT  Kanban to achieve JIT (mfg)  iLog for Design of your SC  inFlow, Inventoria, Stock it Easy for inventory management  GT Nexus for In Transit Info  Slingshot, Forecast Pro, Epicore, JDA for demand forecasting
  • 16. AFRIS. AsianFoodRegulationInformationService. We have the largest database of Asian food regulations in the world and it’s FREE to use. We publish a range of communication services, list a very large number of food events and online educational webinars and continue to grow our Digital Library. We look forward to hearing from you soon! www.asianfoodreg.com adrienna@asianfoodreg.com