Title: PRO/13 - VALIDATION OF SPECIAL PROCESSES Doc. No.

:
PRO/QA/5.7.1.5
FOR PRODUCTION & SERVICING
Issue Number: Issue Date: Rev.: Rev Date:
01 14.04.2015 00

1.0 PROCEDURE ON VALIDATION OF PROCESSES FOR PRODUCTION & SERVICING.

2.0 PURPOSE:

 To detail the procedure to address methods for review & approval of special processes for
production & servicing.

3.0 SCOPE:

 This procedure covers the requirements of API Spec Q1, API 6D & API 600.
 To address validation of processes identified by applicable product specification requiring validation.

4.0 RESPONSIBILITY:

 Head (Production) for Welding ,Painting Process, Heat treatment, ENP

 Head (QA) for RT,UT,PT,MT, Calibration of TMMEs
 Head (Purchase) for out sourced processes requiring validation

5.0 AUTHORIY & ACCOUNTABILITY:

 VP(Operations)

6.0 REFERENCE DOCUMENTS:

 Procedure on management of change (PRO/MR/5.11)

 Procedure on control of records (PRO/MR/4.5)
 Painting process validation chart (C/PRD/01)
 Work instructions for Paint process(WI/PRD/05)
 Surface preparation & coating procedure for the Products ( PS 1012)
 WPS,PQR,WPQ
 Dye penetrant examination procedure ( -NDT-DP-01)
 Magnetic Particle inspection procedure( -NDT-MT-02)
 Procedure on storage & control of welding consumables ( /PRD/01)
 Procedure for Purchase & out sourced processes (PRO/PUR/5.6)

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 Title: PRO/13 - VALIDATION OF SPECIAL PROCESSES Doc. No.:
PRO/QA/5.7.1.5
FOR PRODUCTION & SERVICING
Issue Number: Issue Date: Rev.: Rev Date:
01 14.04.2015 00

7.0 PROCEDURE:

 The organization involves following in-house & outsourced processes that require validation:

In-house carried processes requiring validation Out sourced processes requiring validation
NDE(LP, MPI), NDE(MT,RT,UT),ENP,
Painting, Welding Painting, Heat treatment

 The validation process controls for in-house processes is high-lighted below whereas for out sourced
processes it is mentioned in the “Procedure on Purchase & outsourced processes”.

 The validation of Welding process is carried out as below :

a) The welding processes equipment’s, materials employed (base metal & weld metal),
methodology employed, process control parameters & acceptance criteria have been
standardized & process qualified through generating WPS, PQR & WPQ.
b) The welders & applicable welding processes for product requirement are qualified by Head
(Prod) in association with Head (QA) based on the ASME – section-IX standard’s requirements or
other standard requirements.
c) For each combination of weld metal & base metal & the process to be carried, the welder is
qualified by generating PQR & WPQ before performing the process.
d) The welding process where required in the product is carried out by the qualified welder only
based on the WPS, PQR & WPQ.
e) The lists of WPS, PQR, WPQ & qualified welders for various combinations of weld metal & base
metals are maintained by the organization for welding requirements.
f) The revalidation of the WPS/PQR/WPQ shall be carried out in case of change in product or
process requirement, applicable ASME standards, qualified person ,equipment, materials or if
the qualified welder has not performed the qualified welding process for a period of six months.
g) The WPS/PQR/WPQ shall be prepared & approved by competent QA Head/TPI.
h) The welding consumables used shall confirm to AWS/ASME or organization’s specifications. A
“written procedure on storage & control of welding consumables” has been made & followed for
their storage & control process. The materials of low hydrogen type (including electrodes, wire &
fluxes) are stored and used as recommended by the manufacturer of welding consumables.

 The validation of Painting process is carried out as below :

a) The required equipment’s, materials, methodology employed, process control parameters &
their acceptance criteria etc. have been standardized for application of painting process.
b) It includes the surface preparation, application of primer & painting and their after drying as per
customers/process requirement.

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 Title: PRO/13 - VALIDATION OF SPECIAL PROCESSES Doc. No.:
PRO/QA/5.7.1.5
FOR PRODUCTION & SERVICING
Issue Number: Issue Date: Rev.: Rev Date:
01 14.04.2015 00

c) The personnel employed for this process are trained based on their internal/external training.
d) The above requirements have been described in Painting process validation chart ( )
e) Using the work instructions for painting process ( )
f) The requirements highlighted in procedure on coating/painting process shall be followed for
control of painting /coating process.
g) The validation requirements as above are approved by Head (QA)
h) The process requires re-validation in case of change in process, equipment, person, base metal,
control parameters, acceptance criteria or material to be employed .In such cases Head (QA)
shall revalidate it & approve before its implementation.
i) Based on above the Head (QA) periodically validates the process through sample testing
internally or externally.

 The validation of NDE (LP)process :

The NDE process - LP is carried out in-house by the organization & is validated as below:

- With application of requirement for process validation as per approved procedure for LPE
based on process standard.
- Carrying out the activity by person trained as NDE-level-II
- The equipment’s & materials used are standardised.
- The process revalidation shall be carried out only if requirements are changed in the
standard, product, process, equipment, material, procedure & qualified person are revised.
- HOD (Prod) is in-charge of this process.

 Based on above the process is validated by Head (QA) periodically through samples testing internally
or externally.
 The records of validation process are maintained by Head(Prod) as per the procedure on control of
records

Reviewed By : Head - QA Approved By : Managing Director

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