1. 1
Fuzzy labeling to product safety conformity
Do we need Change?
Mr. Hongwei SHI cesafe@qq.com
2. 2
If you have a look at EU RAPEX or USA
CPSC Recalls:
You will find that 99% of product recall due to: non-
conformity to current standards / regulations.
3. 3
Let’s try to explore what is the real cause this
long-term of headache ……
4. 4
The tangible product manufactured in the
factory is the carrier of the product safety.
Once the packaged product leaves factory, no
economic operator in the subsequent distribution chain
would like to verify its safety, because that need
professional facility and of the knowhow, and damage to
the product and delays potential lead time.
So, whether the conformity status has been verified
and correctly labeled before they leave the factory is
most important concern of.
Some core product safety conformity principles:
5. 5
So….., Let’s have a look to the current product
safety conformity labeling, to see whether it
provides the verification information we
concerned with.
6. 6
You can find product safety labeling info on
the data plate of consumer products
7. 7
The contents of these label consists of:
The name and address of manufacturers( who
marketed the product under his name or trademark, and
is responsible for product safety obligations)
The name of the product (model, type..)
Product safety mark
8. 8
Does the current conformity labeling
satisfied our previous concern? NO!
The name and address of manufacturers: For
consumer products, 80% of the manufacturer name
occurring on the data plate are not the factory, just
brand holder.
The name of the product (model, type..): 90% of
consumer products have no production batch
identification number on the data plate.
Product safety mark: 100% of product safety
markings are printed on the data plate as the part of the
product, no relation with batch conformity status
verification.
9. 9
Of course….
The manufacturer( brand holder) may show you the
proof of conformity: various of certificates and testing
reports. Unfortunately, it may be based on “Golden
sample” (special designed prototype)
10. 10
ISO/IEC Guide 65
General Requirements for Bodies operating Product
Certification Systems
“…. Within a product certification system the roles of a
supplier and of the certification body are complementary,
the former being responsible for conformity of the
product…..”
But, there is no guide provided to
the supplier how to verify batch
conformity.
Conformity verification
11. 11
The “Blue Guide”
on the implementation of EU product rules 2014 v1.1
4.5.1.4 Principles of affixing the CE parking:“… However,
if (for example) the CE marking is affixed by stamping or
casting, the marking can be affixed at any other stage of
the production phase, provided that the conformity of the
product is verified as part of the production process …..”
But, there is also no guide provided
how to verify conformity.
12. 12
The “Golden mask” is also well-known in
consumer products supply chain…..
“Golden Sample”: the special designed product sample,
only used for passing safety test and attract order.
“Golden Factory”: It is showed to buyers a well
organized and high quality focused factory. But actually
only 10~20% order will be produced in here, others were
manufactured clandestinely in another bad quality but
cheap operation cost factory.
“Golden Procedure documents”: the quality control
procedure documents is only for “external auditing” and
then stored in file cabinet.
13. 13
So you will see the typical “man-made complex supply
chain”: hiding the real factory might be more profitable to
them. It is estimated that more than 40% consumer products
are produced in a “hidden factory” and there is no any
conformity scheme.
Manufacturer Distribution
Golden factory
Export trader
(brand holder)
Hidden factory
Hidden factory Hidden factory
consumer(golden sample provider)
(golden sample provider)
14. 14
Profit maximization becomes a trend in the
product testing and certification body
On one hand, they persuade EU and American manufacturers
(brand holder) to put pressure on the supply factory to accept
more and more testing and certification to reduce their concern
on safety conformity.
On the other hand, they connive the existence
of “golden sample, golden factory and golden
documents” in factory, make “good friends”
with the factory to got maximum commercial
incoming on test and certification.
15. 15
Dreams vary with reality
The consumers and legislation require:
“… all consumer products must be safe
when placed on the market..”
But ..the reality is : “ ..maybe only 50% of consumer
products batch conformity has been controlled and verified
before it leaves the factory..” the current conformity
labeling only proves the manufacturer (brand holder) has a
prototype conformity testing report / certificate.
16. 16
No batch conformity verification and labeling
requirements and guidance to the factory!
All of these is due to……
17. 17
Question
If we agree, somebody should verify and label the
batch conformity status of the product before it’s out
of factory, that is a most important way to improve
consumer product safety……
Why choose “batch”
instead of “every single product” ?
18. 18
Answer
“Batch” is the minimum production plan unit in
factory.
Same batch, in theory, means same BOM (bill of
materials), same raw materials, same production
process, same quality control plan…
“Conformity” is different from “ordinary quality”, its
control baseline should from a type approved
sample and its trial production
process.
19. 19
Fundamental operational principles for factories:
All products should be technically described in as much
detail as possible to identify any minor changes which may
affect conformity, such as : BOM, drawing, critical process
parameters, routine test etc.
Any product manufacturing should based on a controlled
technical document.
Each production operations should have written order and
performance records can be tracked.
Appointment of a product conformity representative.
20. 20
10 steps to verify a batch conformity (Ⅰ)
1. Verify the sample of conformity testing: verify sample to
confirm its technical documents, such as :BOM, raw
material and its supplier, IQC criteria, critical process
parameters, final testing and quality criteria etc.
2. Verify the testing report of sample: competent and
qualified laboratory / certification body. Precise testing
records and positive conclusion.
3. Effective technical documents control: once the sample
testing passed, all related technical documents should
be controlled. Any modification to these documents
should be conformity re-evaluated.
21. 21
10 steps to verify a batch conformity (Ⅱ)
4. Verify commercial contract: No any commitments may
decrease conformity existed in.
5. Verify production plan and MRP : material planning
should be based on controlled BOM .
6. Verify IQC records: Incoming material should be from
approved suppliers and within the approved material
list, quality records fulfill with controlled criteria
documents.
7. Verify critical process records: IPQC records fulfill with
controlled criteria documents.
22. 22
10 steps to verify a batch conformity (Ⅲ)
8. Verify final routine test records: all test records meet the
requirements of conformity.
9. Labeling the batch conformity: batch number should be
identical with records in production plan and MRP.
10. Declaration and registration: registering the batch
conformity declaration in a public accesible website
which may be maintained by a notified body.
23. 23
Sample label of batch conformity verification
The batch conformity has
been verified by factory,
the verification records can
be accessed via scan
QR-Code by your smart
phone.
Batch No.XXXXXXX
24. 24
If you scan QR-Code, will link to a notified body
maintained and public accessed database:
APP: This pot seems have proplem…
MIKE: the power cord dameged…
Etc…
feedbacks to market
surveillance authority
NE-201 electrical brewing pot
OK
TUV
ND35627-2015
11256
picture
Product type / name
Surveillance & Recall:
Verification records:
Notified body:
Batch No.
Factory No.
25. 25
illustration to batch conformity scheme
Manufacturer Distribution
Golden factory
Export trader
(brand holder)
Hidden factory
Hidden factory Hidden factory
consumer(golden sample provider)
(golden sample provider)
Notified body A
Data base
Market
Surveillance
authority
Notified body A
Data base
26. 26
Notified body
Batch conformity management system( see fundamental
principles in page 19 )
Any certification body accredited on batch conformity
management system could submit application to market
surveillance authority.
The notified body who got the authorization to supervise
batch conformity verification, should operate a public
accessible web database for factory batch conformity
verification registering.
27. 27
Advantage of this Scheme
The conformity verification of all consumer
products on the market can be tracked back
to the factory.
The factory will choose good third party as certification and testing service
provider. Conformity will not just a paper of certificate / testing report.
“Golden sample”, “golden factory”, “golden records” and “hidden factory”
will disappeared.
The majority power of conformity will be factory, not the game of certification
/ testing body and manufacturer (brand holder).
The manufacturer and buyer can perform the sourcing more efficiently via
checking the verification records in website of notified body to focus on good
conformity management factory.
At the end, the consumer will have more safer products.
