7.5.2 Validation of Processes - Robotic welding of steel components

K

katie

#1
#1
7.5.2 still not quite getting it

We are close (October) to 9001:2000 Registration audit and have still not hammered out 7.5.2 - We seem to be having differences of interpretation - Our Manufacturing process is Robotic welding of steel components.

We do daily random sample testing including hardness/breakdown and measurement on each component each run. There are no "processes that cannot be verified by subsequent measurement" on the sample components. We do not test each part of the run, just every area on 1 sample component per day according to 8.2.4.

Occasionally changes or improvements are made to the process or Equipment. Trial components manufactured using the new process or equipment are re verified according to 7.2 and 7.1 before the changes go into production. Again, Every area on the trial components can be verified.

Because we can verify all areas of the product do we need to validate the process? We don't have any "Hidden" or "special" processes. Should we exempt ourselves from 7.5.2 or are we already validating the process and just don't realize it because it is covered under different elements.

Let me know your thoughts. Thanks in advance
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
R

Randy Stewart

#2
#2
Katie,
I'd use my teardowns as validation. You know all you're doing in validation is proving the process. So by doing a teardown you validate the weld integrity, in turn a pull test may validate the teardown, tip checks can validate the pull test, etc.
IMO don't exempt use what you have.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11
Stoic Manual soldering processes - 100% verifiable, or always requiring validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
J ISO 13485 - 7.5.2 cleanliness , 6.4.2 validation of special processes, and 6.4.2 contamination ability to be exempt? ISO 13485:2016 - Medical Device Quality Management Systems 5
GoSpeedRacer Validation of Processes 7.5.6 - Do cosmetic welds need process validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Review ISO 13485:2016 - Medical Device Quality Management Systems 7
S Re-validation NCR - In which cases re-validation of processes is required Oil and Gas Industry Standards and Regulations 6
M AS9110C Clause 8.5.1.2 Validation and Control of Special Processes for Repair Station AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
W AS9100D Clause 8.5.1.2 Validation and Control of Special Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37
D 7.5.2 Validation of Processes for Production and Service Provision AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
L Validation Processes of Production & Servicing - API Q1 clause 5.7.1.5 Oil and Gas Industry Standards and Regulations 2
A 7.5.2.1 Validation of Processes for Production and Service Provision IATF 16949 - Automotive Quality Systems Standard 7
I Bracketing for Validation - Processes that share some unitary operations Qualification and Validation (including 21 CFR Part 11) 4
D 7.5.2 Validation of Processes for Production and Service Provision - Distributor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Y 7.5.2 Validation of Processes for Production and Service Provision Discussions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J ISO 9001 Clause 7.5.2 Validation of Processes - How to comply? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
M Looking for a simple procedure on section 7.5.2 for Validation of Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S ISO/TS 16949 - 7.5.2 - Validation of Processes And 7.5.2.1 All Processes IATF 16949 - Automotive Quality Systems Standard 1
E What are Validation Requirements for Vendor (Supplier) Processes Supplier Quality Assurance and other Supplier Issues 5
K Validation of Processes does not seem to apply - Scientific Research Company Design and Development of Products and Processes 1
H Excluding 7.5.2 - Validation of Processes for Production and Service Provision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
S 7.5.2 Validation of Processes for Production and Service Provision AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 56
F External Storage of Data - ISO 9001 Clause 7.5.2 Validation of Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Validation of Special Processes - Are Casting and Forging Special Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
N Validation of Special Processes - N/A of ISO 13485 Clause 7.5.2 ISO 13485:2016 - Medical Device Quality Management Systems 12
B Validation of Processes for Production and Service Provision - 7.5.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Understanding AS9100 Clause 7.5.2 Validation of Processes for Production and Service AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Validation of Processes - Is Cl 7.5.2 applicable to bricktile firing in an oven? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
L Outsourcing "passivation" - Clause 7.5.2 Validation of Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Validation of processes for production for Test Equipment ISO 13485:2016 - Medical Device Quality Management Systems 9
O Format for Clause 7.5.2 (Validation of Processes) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T Validation of processes 7.5.2 - We are a label printer ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Validation of processes for production & service provision - Service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
S Validation Of Outsourced Special Processes under AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
V Validation & which processes are called special processes & why not all the processes Manufacturing and Related Processes 9
V Validation of Processes for Production and Service Provision Procedure Document Control Systems, Procedures, Forms and Templates 8
C Equipment, Software and Processes Validation for Medical Devices - 21CFR 820.75 (a) ISO 13485:2016 - Medical Device Quality Management Systems 35
R Validation of Processes for Production and Service Provision - Clause 7.5.2 IATF 16949 - Automotive Quality Systems Standard 4
L Validation of Processes - Plastic Injection Moulding - ISO 9001 Clause 7.5.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
K Validation of Processes - How do I address TS 16949 Sec. 7.5.2.1 IATF 16949 - Automotive Quality Systems Standard 30
L Validation of Processes - Resulting Output can not be Verified - Exclusion to 7.5.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
R Validation of Processes for Production - How are doing it? Clause 7.5.2 Reliability Analysis - Predictions, Testing and Standards 25
R Validation of outsourced processes - Calibration - How do we validate that? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
M Software Validation Processes - Telecommunications software Software Quality Assurance 10
A Validation of Processes - How to meet requirement of TS 16949 para. 7.5.2.1? IATF 16949 - Automotive Quality Systems Standard 12
M Examples for Clause 7.5.2 - Validation of processes for production and service ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Process Validation of 'Special Processes' - How do I? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Exclusion from Validation of Processes for Production and Service Provision? Service Industry Specific Topics 17
J 7.5.2.1 Validation of processes - supplemental requirement IATF 16949 - Automotive Quality Systems Standard 11
S How to cope with the validation of processes - Services Service Industry Specific Topics 6

Similar threads

Top Bottom