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1 Fuzzy labeling to product safety conformity Do we need Change? Mr. Hongwei SHI [email protected]

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Page 1: Fuzzy conformity labeling need change -NEW

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Fuzzy labeling to product safety conformity

Do we need Change?

Mr. Hongwei SHI [email protected]

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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.

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Let’s try to explore what is the real cause this long-term of headache ……

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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:

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So….., Let’s have a look to the current product safety conformity labeling, to see whether it provides the verification information we concerned with.

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You can find product safety labeling info on the data plate of consumer products

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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

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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.

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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)

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ISO/IEC Guide 65General 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 tothe supplier how to verify batch conformity.

Conformity verification

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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.

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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.

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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)

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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.

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Dreams vary with realityThe 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.

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No batch conformity verification and labeling requirements and guidance to the factory!

All of these is due to……

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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” ?

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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.

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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.

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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.

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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.

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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 websitewhich may be maintained by a notified body.

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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

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If you scan QR-Code, will link to a notified bodymaintained 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

OKTUVND35627-201511256

pictureProduct type / name

Surveillance & Recall:Verification records:

Notified body:Batch No.

Factory No.

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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 AData base

MarketSurveillance

authority

Notified body AData base

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Notified bodyBatch 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.

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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.

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Thank You!