The purpose of the procedure is
- To validate processes for production where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use.
- To demonstrate the ability of these processes to achieve planned results.
- To maintain supplier conformance to these requirements
- To define the method for controlling the performance of special processes.
It applies to all processes that have been designated as special processes.
This procedure is applicable to all the following systems and standards
- ISO 29001: 2020/ API Spec Q1, 9th edition
- API Spec ….
- API Spec ….
- API Spec …..
- API Spec ….
- API Spec ……
- QA/QC Engineer
- Operations Engineer
- Machine Shop Manager
- All concerned personnel
Requirements for validation
- Competent Manpower, Requires equipments & MMEs
- Standard specifications/requirements
- XXX Procedures/Work Instructions
To monitor the special processes to ensure controls are effective in their application.
The main concerns of Quality Assurance are:
- To maintain a consistency of quality product/service
- To inspect and test the product/service with proper calibrated instrument and gauges within the timeframe with respect to the overall objectives
- To develop good relationship within the process in order to create an environment which enables XXX to discover new ideas
- To achieve a high degree of cooperation and coordination with other departments and customers as well as third party inspectors
- To maintain proper records and controls and assure efficiency and integrity
- To ensure proper usage of allotted resources
- To introduce standardization in requirements in order to simplify the specification
- To be aware of secondary objectives which are supportive of other functions of XXX
- XXX validates process for production and servicing where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use or the servicing has been delivered.
- Validation demonstrates the ability of these processes to achieve planned results. Where XXX chooses to outsource a process that requires validation, XXX requires that the supplier conform to these requirements.
IDENTIFICATION OF SPECIAL PROCESS
The processes are identified as special processes in XXX with following controls as mentioned in Annexure – A .
7.1 VALIDATION OF WELDING PROCESS:
7.1.1 WELDING PROCEDURE QUALIFICATION
In XXX, all Welding Procedure Specifications (WPS) and Procedure Qualification Record are prepared and Qualified in accordance with ASME Section IX. The detailed procedure is documented in Level III
7.1.2 WELDER QUALIFICATION
In XXX, welders are evaluated as per the documented procedure before allowing them to weld.
7.1.3 CONTROL OF WELDING CONSUMABLES
The procedure for Storage, Handling & Issue of welding electrodes is documented in the Level III.
7.1.4 BAKING OF LOW HYDROGEN ELECTRODES
Work Instruction explains the step by step procedure for baking of low hydrogen electrodes in the Oven.
7.1.5 CALIBRATION OF WELDING MACHINE
All welding rectifiers are calibrated once in every six months as per the approved Quality Internal Procedure.
7.1.6 CALIBRATION OF ELECTRODE BAKING OVEN
Electrode baking ovens are calibrated once in every six months as per the documented Quality Internal Procedure.
7.2 VALIDATION OF HEAT TREATMENT PROCESS
7.2.1 HEAT TREATMENT PROCEDURE
A documented Quality Internal procedure for post weld heat treatment is followed in XXX for performing heat treatment process.
7.2.2 CALIBRATION OF HEAT TREATMENT FURNACE
Heat Treatment furnace is calibrated once in a year as per the documented procedure.
7.3 NON DESTRUCTIVE TESTING
The following NDT processes are identified for validation in XXX:
- Liquid Penetrant Test
- Magnetic Particle Test
7.3.1 LIQUID PENETRANT TEST
XXX conducts the Liquid Penetrant Examination as per the documented procedure approved by a Level III certified NDT personnel.
7.3.2 MAGNETIC PARTICLE TEST
XXX conducts the Magnetic Particle Examination as per the documented procedure approved by a Level III certified NDT personnel.
8.0 SURFACE PREPARATION & PAINTING
A detailed documented procedure is followed to do the activities surface preparation and painting along with the safety precautions.
APPLICATOR QUALIFICATION PROCEDURE
Quality Internal Procedure describes the procedure for qualifying the personnel performing the blasting and coating processes.
QMS SPECIFIC REQUIREMENTS
XXX validates the processes for production where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use. Validation demonstrates the ability of these processes to achieve planned results. Where XXX chooses to outsource a process that requires validation, XXX validates that the supplier conform to these requirements
XXX maintains a documented procedure (L2 – 13: Validation of process) to address methods for review and approval of the processes including:
- Required equipment;
- Qualification of personnel;
- Use of specific methods, including identified operating parameters;
- Identification of acceptance criteria;
- Requirements for records; and
XXX validates those processes identified by the applicable product specification as requiring validation.
Validation records for each process.
10.0 KEY PERFORMANCE INDICATORS
11.0 ASSOCIATED DOCUMENTS & RECORDS
|Calibration of welding rectifier||QIP – 10||QA/QC Engineer|
|Calibration of electrode ovens||QIP – 11||QA/QC Engineer|
|Calibration of heat treatment furnace||QIP – 12||QA/QC Engineer|
|Control of Welding Consumables||QIP – 22||QA/QC Engineer|
|Surface Preparation & Painting||QIP – 31||QA/QC Engineer|
|Thermocouple welding procedure||QIP – 34||QA/QC Engineer|
|Post weld Heat Treatment procedure||QIP – 39||QA/QC Engineer|
|Welding Procedure Specification||QIP – 40||QA/QC Engineer|
|Magnetic Particle Examination||PRO / NDE / 04||QA/QC Engineer|
|Liquid Penetrant Examination||PRO / NDE / 05||QA/QC Engineer|
|Liquid Penetrant Test Report||XXX / QA / 05||QA/QC Engineer|
|Magnetic Particle Examination Report||XXX / QA / 06||QA/QC Engineer|
|Daily Blasting & Painting Report||XXX / QA / 08||QA/QC Engineer|
|Heat Treatment Inspection and Report||XXX / QA / 11||QA/QC Engineer|
|Welder Qualification Review||XXX / QA / 13||QA/QC Engineer|
|Welding Procedure Specification||XXX / QA / 31||QA/QC Engineer|
|Process Validation Record||XXX / QA / 39||QA/QC Engineer|
Annexure – A
|Process||Equipment||Personnel Qualification||Method||Acceptance Criteria||Records||Revalidation|
|Welding||Refer procedure QIP-40||Welder, Welding Inspector||As per WPS||Applicable Standards||WPS, PQR, WQT, Process Validation Record||Change in variables for procedures and performance & applicable standards|
|PWHT||Refer procedure QIP-39||PWHT Technician||As per WPS and PWHT Procedure||Applicable Standards||PWHT Record, Process Validation Record||Change in variables for procedures and performance & applicable standards|
|NDE||Refer Procedure PRO/NDE/04 & PRO/NDE/05||NDT LEVEL II Personnel||As per NDE Procedures||Applicable Standards||NDE Reports, Process Validation Record||Change in variables for procedures & applicable standards|
|Protective Coating||Refer procedure QIP-31||Blasting Operator, Painter & NACE Level II inspector||As per Product data sheets, blasting & Coating procedure||Applicable standards||Blasting & Coating Report, Process Validation record||Change in the coating cycle, coating material and applicable standards|