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