DTI Hongxi 2012 inspection report
description
Transcript of DTI Hongxi 2012 inspection report
INSPE Year of in2012 Certificat
1.51/18
VTT-RT
SC0403 1603
Approval DIMPEXP36, rue VigF-750009 France ManufactHong Xi VInd. Zone,Yuhuan CZhejiang China Date of in18 Octobe InspectorEric Guan Control aNo. 230 of Order No495792
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Danish Technological
Institute
REQUIREMENTS FOR THE INTERNAL INSPECTION
DOCUMENTATION
Initials: KLE Appendix: 1 of 5 Page: 1 of 6
Order No.: 495792
Check questions OK
+/-
Inspected field
Remarks
Follow-up on previous audit
0 Quality Manual
0.1 Is a quality manual available in the company? + +
0.2 Is the personnel familiar with the contents of the quality manual?
+ +
0.3 Who is responsible for maintaining the quality manual? + + Deputy General Manager
0.4 Does the company have an ISO 9000 certification? If so, which one?
+ + ISO 9001:2008
1 Organisation (applies to design, production, purchase and control)
1.0 Is the person who is responsible for the internal control organisationally independent of the production?
+ +
1.1 Have the personnel’s responsibilities been made clear regarding design, production, purchase and control? And is this allocation of responsibilities available in writing?
+ +
1.2 Is the production personnel familiar with the products that should be marked with seals of approval?
+ +
1.2.1 Who is responsible for planning the production process so the products meet the requirements of current specifications?
+ + Supervisor of production
1.2.2 Who is responsible for deciding whether the products comply with the current standards or not?
+ + Supervisor of inspection
2 Documentation
2.1 Are the product certification requirements and current standards available at the licensee/ manufacturer? (The licensee is responsible for the documentation being available at the place of production).
+ +
2.2 Are there instructions/drawings regarding current specific provisions and standards?
+ +
2.2.1 Who is responsible for instructions and drawings being available?
+ + Deputy General Manager
Danish Technological
Institute
REQUIREMENTS FOR THE INTERNAL INSPECTION
DOCUMENTATION
Initials: KLE Appendix: 1 of 5 Page: 2 of 6
Order No.: 495792
Check questions OK
+/-
Inspected field
Remarks
3 Purchasing routines – receiving inspection – storage
3.0 Is a list of suppliers/subcontractors available? + +
Purchasing routines
3.1 Are procedures and instructions available regarding quality control of purchased raw materials/semi-manufacture?
+ +
3.1.1 How are the mentioned procedures and instructions documented?
+ + Document according to the ISO 9000 system
3.1.2 Who is responsible for ensuring that purchased raw materials and other materials used for manufacturing the products are of the correct quality?
+ + Supervisor of inspection
Receiving inspection
3.2 Are there procedures for which products that must be inspected?
+ +
3.2.1 Is documentation available, stating who is responsible for inspecting received products?
+ +
3.2.2 Are certificates or control reports normally received from subcontractors?
+ +
3.2.3 Is the number of accepted and rejected products recorded at the receiving control?
+ +
Storage
3.3 Are there procedures for when and how components with certification right should be secured/stored to prevent damage to or confusion with other products, so that non-complying products can be avoided?
+ +
3.3.1 Who is responsible for the procedures? + + Warehouseman
4 Production process
4.0 Who is responsible for the production? + + Supervisor of production
General
4.1 What sort of internal control and testing is carried out during the production process?
+ + Dimension and 100% leak test
4.1.1 When is the internal control and testing carried out? + + When starting and during production
4.1.2 Who carries out the internal control and testing? + + Supervisor of inspection
4.1.3 Are the internal control and test results recorded? + +
4.1.4 Is the number of accepted and rejected products recorded? + +
Danish Technological
Institute
REQUIREMENTS FOR THE INTERNAL INSPECTION
DOCUMENTATION
Initials: KLE Appendix: 1 of 5 Page: 3 of 6
Order No.: 495792
Check questions OK
+/-
Inspected field
Remarks
Inspection during the production process
4.2 Is conformity between drawings and specifications checked? + +
4.2.1 Who inspects conformity between drawings and specifications?
+ + Deputy General Manager
4.2.2 Who is responsible for preparing the control instructions so that they comply with the current standards?
+ + Assistant General Manger
4.2.3 What procedures exist for control of materials during the production process and delivery?
+ + Measuring instructions for material inspection
4.2.4 Who carries out control during the various production stages? + + Supervisor of inspection
4.3 How are the products inspected at the final inspection? + + Spot check 100% according to standard EN 13828-2003,
Identification/marking
4.4 Who is responsible for establishing procedures for correct identification/marking?
+ + Assistant General Manager
4.4.1 Who carries out marking, and when is it carried out? + + Warehouseman
4.4.2 How are products and components identified during storage/ transport through the production premises?
+ + Identified from the packing or identification card
4.4.3 Where is marking carried out (manufacturer/distributor)? + + In workshop
Installation instructions
4.5 Are there procedures for ensuring that product deliveries are accompanied by installation instructions?
+ +
4.5.1 Which types of installation instructions are available? + + Production Manual
Record-keeping
4.6 Is the internal control recorded for tracing certified products? + +
4.6.1 Who is responsible for record keeping? + + Warehouseman
Maintenance of production tooling equipment
4.7 Is there documentation of how production tooling equipment is maintained so the equipment conforms to the product specifications?
+ +
Danish Technological
Institute
REQUIREMENTS FOR THE INTERNAL INSPECTION
DOCUMENTATION
Initials: KLE Appendix: 1 of 5 Page: 4 of 6
Order No.: 495792
Check questions OK
+/-
Inspected field
Remarks
5 Handling, storage and packaging/delivery of certified products
General
5.1 Are there procedures for handling, storage and packaging/ delivery of certified products?
+ +
Handling
5.2 Are there procedures for how products should be handled to prevent damage or deterioration?
+ +
Storage
5.3 Are there procedures for how finished and marked products should be stored to prevent the products from being damaged or mixed up with other products?
+ +
Packaging/delivery
5.4 Are there procedures for how the products should be packed to prevent damage during transport?
+ +
6 Handling of non-complying products and corrective action
Non-complying products
6.1 Are there procedures for how non-complying details and products should be identified and handled?
+ +
6.1.1 Are there procedures for how products not meeting the requirements of current standards should be marked/ segregated?
+ +
6.1.2 Who is responsible for the procedures? + + Supervisor of inspection
Notification of defects/customer complaints
6.2 Are there procedures for how defective products that have been returned to the manufacturer should be handled?
+ +
6.2.1 Are there procedures for which measures should be taken in case of complaints?
+ +
6.2.2 Are all complaints and corrective actions registered for products covered by the marking licences?
+ +
6.2.3 Are there procedures for how the corrective actions are followed up?
+ +
6.2.4 Are the effects of the corrective actions documented? + +
Danish Technological
Institute
REQUIREMENTS FOR THE INTERNAL INSPECTION
DOCUMENTATION
Initials: KLE Appendix: 1 of 5 Page: 5 of 6
Order No.: 495792
Check questions OK
+/-
Inspected field
Remarks
Deviations
6.3 Are there any descriptions of which type of defects and level of nonconformity that can be accepted before the components must be taken out of the production?
+ +
6.3.1 Who decides which type of defects that can be accepted? + + Deputy General Manager
6.4 Are there procedures for corrective actions? + +
6.4.1 Are corrective actions recorded? + +
6.4.2 Who is responsible for carrying out corrective actions? + + Assistant General Manager
7 Control equipment
Calibration
7.1 Who is responsible for the calibration and maintenance procedures?
+ + Deputy General Manager
7.1.1 Are there procedures for measuring and control equipment due for calibration/control?
+ +
7.1.2 Are there procedures for maintenance of measuring and control equipment?
+ +
7.1.3 Are calibrations performed on/with traceability to accredited calibrated laboratory/measuring and control equipment?
+ +
7.1.4 Are reports on calibrated measuring and control equipment available?
+ +
8 Updating
Updating procedures
8.1 Are there procedures for contact with the certification bodies in case of change of materials, design or production methods for verification of whether the requirements of the current standards have been met or not?
+ +
8.1.1 Who is in contact with the certification bodies? + + DIMPEXP SAS, France
8.1.2 Are there routines for when and how updates and amend-ments to the internal control documentation should be carried out?
+ +
8.1.3 Who is responsible for updating and making amendments to the internal control documentation?
+ + Deputy General Manger
Danish Technological
Institute
REQUIREMENTS FOR THE INTERNAL INSPECTION
DOCUMENTATION
Initials: KLE Appendix: 1 of 5 Page: 6 of 6
Order No.: 495792
Check questions OK
+/-
Inspected field
Remarks
9 Internal control
9.1 Has the company conducted internal control according to current standards?
+ +
9.1.1 Are the internal control results recorded? + +
9.1.2 Who is responsible for the internal control? + + Assistant General Manager
10 Samples for audit testing
10.1 Have samples been taken? + + Samples are taken in accordance with the control agreement
10.2 According to which method were the samples taken?
10.3 Which samples were taken?
10.4 Where were the samples taken?
10.5 When were the samples taken?
10.6 Who took the samples?
11 Application of licenses and identity markings
11.1 On which documents is the marking being applied? (Invoices, delivery notes, quotations, acknowledgement of orders, products)
+ +
11.2 Is the approval marking (logo) being used correctly? + +
11.3 Are the identity markings being used in connection with marketing? (see examples like catalogues, website, etc.)
+ +
11.4 How are the licenses/certificates being filed? + +
11.5 If any copies of licenses/certificates are available – in what way are the copies being used?
+ +
DaTechn
Ins
anish nological stitute
TEST RERAW MAT
EPORT TERIAL
Init
ials: KLE AppendixPage: 1 o
Order No
x: 2 of 5 of 1
o.: 495792
DaTechn
Ins
anish nological stitute
TEST AFHOT PRE
FTER ESSED
Init
ials: KLE AppendixPage: 1 o
Order No
x: 3 of 5 of 1
o.: 495792
DaTechn
Ins
anish nological stitute
SALES CONNTRACT
Init
ials: KLE AppendixPage: 1 o
Order No
x: 4 of 5 of 1
o.: 495792
DaTechn
Ins
anish nological stitute
TTOOL CERTTIFICATE
Init
ials: KLE AppendixPage: 1 o
Order No
x: 5 of 5 of 2
o.: 495792