How to satisfy clause 5.7.1.5 process validation for valve production API 6D
- Thread starter badidi
- Start date
Thee Bouyyy
Multiple Personalities
Hi @badidi, Your question seems to difficult to understand. You have to tell me first that which processes you have already identified for the processes that require validation for valve manufacturing.
E.g. NDT examination like LP, MPI, UT, X-Ray, Welding, Salt Bath Nitriding, Blasting, Painting, Hard Chrome Plating, Local PWHT requires validation.
These process validation records must contain the following information as applicable:
1. Written procedure (specification) about respective process
2. Required equipment to carry out respective process
3. Qualification of personnel who will be performing the process
4. Use of specific methods including identified operating parameters
5. Identification of acceptance criteria
6. Re-validation
7. Records that provides evidence of conformity to requirements.
When you outsource these processes, you have to carry out assessment of supplier for understanding supplier capabilities, available equipment and resources at supplier end for carry out process.
Thanks and have a nice day ahead.
E.g. NDT examination like LP, MPI, UT, X-Ray, Welding, Salt Bath Nitriding, Blasting, Painting, Hard Chrome Plating, Local PWHT requires validation.
These process validation records must contain the following information as applicable:
1. Written procedure (specification) about respective process
2. Required equipment to carry out respective process
3. Qualification of personnel who will be performing the process
4. Use of specific methods including identified operating parameters
5. Identification of acceptance criteria
6. Re-validation
7. Records that provides evidence of conformity to requirements.
When you outsource these processes, you have to carry out assessment of supplier for understanding supplier capabilities, available equipment and resources at supplier end for carry out process.
Thanks and have a nice day ahead.
Thee Bouyyy
Multiple Personalities
You want me to give one of the example from Magnetic Particle Testing/ Ultrasonic Testing/ Radiography Testing/ Liquid Penetrate Testing? For better understanding or you understood by Post #2?
Thee Bouyyy
Multiple Personalities
Example # Validation of Magnetic Particle Examination in line with Clause number 5.7.1.5 of API Specification Q1 - 9th Edition with addendum 2 #
a) Required Equipment - Electromagnetic Yoke
b) Qualification of personnel - NDT level I or NDT level II or NDT level III for performance of magnetic particle examination as per documented procedure. NDT level II or level III for interpretation and evaluation of indications observed during magnetic particle examination as per documented procedure.
c) Use of specific methods including identified operating parameters - Continuous wet fluorescent magnetic particle examination with electromagnetic yoke technique.
d-1) Identification of acceptance criteria - Sufficient magnetic field must be established so that indication on CX-230 Shim shall be achieved while performing magnetic particle examination as per documented procedure.
d-2) Requirements of planned results - Sufficient magnetic field strength must be established so that indication on CX-230 shim shall be achieved while performing magnetic particle examination as per documented procedure.
d-3) Condition for acceptance of procedure validation - Achievement of planned results mentioned above. Establishment of sufficient magnetic field strength so that indication on CX-230 shim shall be achieved while performing magnetic particle examination as per documented procedure.
d-4) Evidence of successful achievement of planned results - Mentioned documented procedure for magnetic particle examination was validated on 11-23-2021 for achievement of indications on CX-230 type of shim on grinded surface, on machined surface as well as on weld surface prepared with wire brush. This concludes successful validation of mentioned procedure.
e) Requirement for records - The records for achievement of planned results and hence successful validation has developed on 11-23-2021.
f) Revalidation - Upon revision of mentioned magnetic particle examination procedure, validation records shall be reviewed by NDT level III for requirements of revalidation. If no revalidation will required, then the same will be documented in the revised magnetic particle examination procedure with revision details.
Hope this will give you the guidance for rest of your identified processes that require validation in line with clause 5.7.1.5. Good Night Pal..
a) Required Equipment - Electromagnetic Yoke
b) Qualification of personnel - NDT level I or NDT level II or NDT level III for performance of magnetic particle examination as per documented procedure. NDT level II or level III for interpretation and evaluation of indications observed during magnetic particle examination as per documented procedure.
c) Use of specific methods including identified operating parameters - Continuous wet fluorescent magnetic particle examination with electromagnetic yoke technique.
d-1) Identification of acceptance criteria - Sufficient magnetic field must be established so that indication on CX-230 Shim shall be achieved while performing magnetic particle examination as per documented procedure.
d-2) Requirements of planned results - Sufficient magnetic field strength must be established so that indication on CX-230 shim shall be achieved while performing magnetic particle examination as per documented procedure.
d-3) Condition for acceptance of procedure validation - Achievement of planned results mentioned above. Establishment of sufficient magnetic field strength so that indication on CX-230 shim shall be achieved while performing magnetic particle examination as per documented procedure.
d-4) Evidence of successful achievement of planned results - Mentioned documented procedure for magnetic particle examination was validated on 11-23-2021 for achievement of indications on CX-230 type of shim on grinded surface, on machined surface as well as on weld surface prepared with wire brush. This concludes successful validation of mentioned procedure.
e) Requirement for records - The records for achievement of planned results and hence successful validation has developed on 11-23-2021.
f) Revalidation - Upon revision of mentioned magnetic particle examination procedure, validation records shall be reviewed by NDT level III for requirements of revalidation. If no revalidation will required, then the same will be documented in the revised magnetic particle examination procedure with revision details.
Hope this will give you the guidance for rest of your identified processes that require validation in line with clause 5.7.1.5. Good Night Pal..
QA Manager
On Holiday
This is so perfectly written as per Q1 clauses 5.7.1.5. First I was confuse to figure out your numbering system as a) to f), later on I realized that you have used this numbering system just to match with clause 5.7.1.5, right ?
QA Manager
On Holiday
Can you give it for PWHT process?
Thee Bouyyy
Multiple Personalities
You're Welcome
Yes, You are right
Which PWHT method you are using ?
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