This document discusses key differences between generic and cold chain supply quality management systems. A Middle Eastern cold chain is more expensive due to temperature extremes and immature regulations. Qualification and validation are often misunderstood, with qualification establishing a process can meet standards through testing, while validation tests a process under controlled conditions. For manufacturing, processes can be validated, but distribution is variable so can only be qualified. Extending quality oversight beyond manufacturing, understanding regulators, having product knowledge, and documenting every cold chain link are critical for quality assurance. Tools like CCQI, HACCP, and inventory management systems can help optimize quality strategies for specific cold chain challenges.

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

15. Questions?
Acknowledgments
Cranfield University
Accenture
Kellogg School of Management
Procter & Gamble Ltd.

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