Professional Documents
Culture Documents
FPC Testing Presentation PDF
FPC Testing Presentation PDF
Product Testing
Requirements for Testing
Testing Types
Potential Issues
www.cemarking.ie
Key Points:
Implementation Deadline 1st July 2013
at
Product
www.cemarking.ie
Testing
ASSESSMENT &
VERTIFICATION OF
CONSISTANCY OF
PERFORMANCE
(AVCP or Attestation level)
www.cemarking.ie
Annex ZA An Overview
Scope and Relevant Clauses for the hEN Which clauses are applicable to
CE marking of the product.
www.cemarking.ie
Responsibility
Tasks
System 1+
Notified Body
Manufacturer
System 1
Notified Body
Manufacturer
System 2+
Notified Body
Manufacturer
System 3
Notified Body
Manufacturer
Manufacturer
System4
No Independent Involvement
www.cemarking.ie
System 4
System4
Manufacturer
No Independent
Involvement
www.cemarking.ie
System 3
System 3
Notified Body
Test Laboratory
Manufacturer
www.cemarking.ie
System 2+
System 2+
Notified Body
Manufacturer
Testing of Samples
www.cemarking.ie
System 1
System 1
Notified Body
Manufacturer
Testing of Samples
www.cemarking.ie
10
System 1+
System 1+
Notified Body
Product Certification
Body
Manufacturer
Testing of Samples
www.cemarking.ie
11
FACTORY PRODUCTION
CONTROL
www.cemarking.ie
12
www.cemarking.ie
13
Production Control
Verification of Tests
Test Plans
Test Records
Treatment of Non-Conformities
Traceability
www.cemarking.ie
14
Documentation
The FPC system should achieve an appropriate level of
confidence in the conformity of the product:
Documented Procedure and instructions for FPC operation
15
Production Control
Production control can include some or all of the following:
www.cemarking.ie
16
17
Tests Plans
Tests will be preformed based on a test plan
developed in accordance with the technical
specifications.
18
Test Records
The manufacture should establish and maintain
records which provide evidence that the product
has been tested.
19
Treatment of Non-Conformities
Procedures to handle non-conforming
products or batches need to be established
This may include isolation and tagging
Once corrected, retest procedures are used
www.cemarking.ie
20
Traceability
It is the manufacturers or agents responsibility
to keep full records of individual products or
batches of products
www.cemarking.ie
21
www.cemarking.ie
22
23
24
www.cemarking.ie
25
26
PRODUCT TESTING
www.cemarking.ie
27
Product Testing
Requirements for product testing must be
established for your specific product.
These requirements may vary substantially
based on your AVCP level and product type.
28
Standards
The Annex ZA details the requirements for:
Factory Production Control
Product Testing
29
ETAs
Developed at the request of the manufacture,
generally with a long lead time, when there is
no harmonised standard in place
www.cemarking.ie
30
31
32
33
34
www.cemarking.ie
35
36
37
38
SUMMARY
www.cemarking.ie
39
www.cemarking.ie
40