Process Validation Format for Press (Stamping) Operations - Help needed

A

atulpatil - 2013

#1
Dear Sir,
I am working in sheet metal press shop manufacturing auto ancillary. Can you help me in process validation for press operations

Atul
 
Elsmar Forum Sponsor
P

prototyper

#2
Re: Here are the Various AIAG PPAP Manual 4th Edition Forms (including Control Plan)

Dear Sir,
I am working in sheet metal press shop manufacturing auto ancillary. Can you help me in process validation for press operations

Atul
What specifically do you need to know?
 
A

atulpatil - 2013

#3
Process Validation Format for Press Operations - Help needed

Dear All

Can anybody will provide process validation format for press operations
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Re: Process Validation

Hello Atulpatil,

Please help me out here: are you referring to printing press? Newspaper reporting? Or grape press? Or pressing (ironing) garments? Or a laminating operation? Or a metals/plastic/some other forming operation? What? I'm not trying to be cute; my Thesaurus listed over a dozen synonyms of the word press.

Also, what standard, if any, are you operating to?
 
A

atulpatil - 2013

#6
Hellow Sir,

I am asking regarding sheet metal press shop/stamping presses operations are like blanking, draw, trim, forming, slotting, piercing, etc

Regards,

Atul
 
P

prototyper

#7
The information you have requested is too vague to provide any more than general information. I would suggest you read through some of the threads in the APQP and PPAP area, starting with What are APQP and PPAP?

If you then have more specific questions on for example PFMEA, Run at Rate, ISIR, etc. then please ask and I'm sure you will get any help you need.
 
A

atulpatil - 2013

#8
Dear Sir,

After APQP phase & during trail run of PPAP batch process validation is carried out earlier days we are doing that activity for only special process like welding from that we are defining min & max limits now our customer is asking same activity for stamping press operations during production process affeting paramters must be validated.
 
P

prototyper

#9
Dear Sir,

After APQP phase & during trail run of PPAP batch process validation is carried out earlier days we are doing that activity for only special process like welding from that we are defining min & max limits now our customer is asking same activity for stamping press operations during production process affeting paramters must be validated.
Stamping is a different type of process to something like welding. With welding, by controlling parameters such as voltage, current, wire speed, etc. you can ensure that the product will be consistant.
Stamping, however, is a different matter. The process is very dependent on variation of the material properties of the steel. A press can be set with a tonnage that works for one batch of material, but the same settings may not give the required result for the next batch.
The material thickness, tensile strength and yield strength can vary within quite broad specifications, therefore the tonnage must be adjusted to suit the material.
If your customer insists on control of parameters, you can issue target settings for the press with a tolerance which may be used to allow for material variation.
 
B

brahmaiah

#10
Dear Sir,
I am working in sheet metal press shop manufacturing auto ancillary. Can you help me in process validation for press operations

Atul
Follow the procedure steps given below:-
1)Inspect the press tool as per tool drawing
2)Document a tool set-up procedure
3)Carry out tool set up as per procedure
4)Produce first off part
5) Inspect the first off as per part drg.
6)If found OK produce 5 more parts
7)Inspect all five parts as per drg.
8)If all five are ok as per drg. Approve the set-up and proceed production
9)Inspect one part every hour and ensure they are ok
10)After the lot quantity is produced inspect the last off part as per drg.
11)If the lost off pat is ok the process is validated successfully
12)Preserve all inspection reports and documents referred above in one bunch.
13)SHOW THEM TO THE AUDITOR WHEN HE ASKS FOR PROCESS VALIDATION RECORDS
V.J.Brahmaiah
 
Thread starter Similar threads Forum Replies Date
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
R PCBA process validation Qualification and Validation (including 21 CFR Part 11) 2
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 6
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
B API Q1 5.7.1.5 Process Validation - Machining, heat treating, Manganese Phosphate and Zinc Plating Manufacturing and Related Processes 2
N Validation procedure, Major NC CAP - Equipment Validation process is not effective ISO 13485:2016 - Medical Device Quality Management Systems 5
D ISO13485:2016 7.5.6 Process Validation Responsibilities ISO 13485:2016 - Medical Device Quality Management Systems 1
Z Who is responsible for writing the validation of a new process? Manufacturing and Related Processes 7
M Requirement for manufacturing process validation in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 8
E Sampling plan for orthopedic implant - Process Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
Z Class 2 medical device - Process Validation - Test sterile or non-sterile units? Qualification and Validation (including 21 CFR Part 11) 4
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
L Injection Moulding Process (Special Process) Validation Food Safety - ISO 22000, HACCP (21 CFR 120) 2
K Is Mold qualification / process validation always required? Manufacturing and Related Processes 7
R Process Validation on CNC Lathe and Milling machining process Design and Development of Products and Processes 1
Q Release of the first batch of a cleared product before process validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Process Validation sample size selection Statistical Analysis Tools, Techniques and SPC 0
P Auditing "process validation" process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
E Cleaning Validation Process of Non-Sterile Implants and Instruments Other Medical Device Related Standards 2
W Design and Process Validation - Different? ISO 13485:2016 - Medical Device Quality Management Systems 6
A Supplier - Process Validation Manufacturing and Related Processes 3
M Medical Device Process validation, Validation of excel spreadsheets used for process Other Medical Device and Orthopedic Related Topics 4
V Tyvek packaging for Medical device process validation Qualification and Validation (including 21 CFR Part 11) 2
L Process Definition and Process Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Can we sell units that were chosen for process validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
S How do I do a Process Validation for soldering process Manufacturing and Related Processes 5
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
A Process Validation of QMS Software ISO 13485: 2016 Cl. 4.1.6 ISO 13485:2016 - Medical Device Quality Management Systems 26
P Root Cause for a Process Validation Batch Failure 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
GoSpeedRacer Validation of Processes 7.5.6 - Do cosmetic welds need process validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
A Is Aeration Process in ETO Sterilization Validation Required? Manufacturing and Related Processes 7
C Does Japan accept the Bracketing Approach for Process Validation Japan Medical Device Regulations 1
A Robotic Sanding and Painting Process Validation Manufacturing and Related Processes 5
alonFAI Gamma Irradiation Process Validation Help Other Medical Device Related Standards 2
J Where does process validation fit within design & development? Design and Development of Products and Processes 7
O Process Mapping prior to Validation and Software to use to Map Process Maps, Process Mapping and Turtle Diagrams 12
M Justification for Not Having a Validation Plan for a Critical Process ISO 13485:2016 - Medical Device Quality Management Systems 4
alonFAI PCBAs Process Validation Help (Regulations FDA) Manufacturing and Related Processes 2
M Is Validation an ongoing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K What are the minimum requirements for Process Validation (Software)? ISO 13485:2016 - Medical Device Quality Management Systems 5
P Process Validation of inherited tooling by Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
L GHTF/SG3/N15R8 - Process Validation and Risk Analysis ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom