Planning of product/Service Realization
Divisional Managers will prepare quality plans on client specific request for the various types of product/services to be effectively implemented by all company personnel.
Customer Related Processes
Identification of Customer Requirements
Customer requirements stated and unstated are identified, defined and documented to include requirements for intended use, delivery, support activities, as well as statutory and regulatory requirements.
Review of Product/Service Requirements
- Inquiries, tenders, contracts and orders will be reviewed to ascertain product/service requirements and to resolve differences between contract/order requirements and tender.
- Verbal order requirements will be documented prior to acceptance.
- The enquiry/tender/contract/order review will ensure capability to meet order requirements and resolve differences due to changes required.
- Contract review records will be maintained for five years.
- Amendments to contracts if any required, will be made by the Department Managers in consultation with the GM and communicated to concerned personnel.
Customer Communication
Capital Middle East LLC will ensure that proper internal/external customer communication channels are established regarding product information, inquiries, tenders, orders, order amendments, customer feed back and customer complaints.
Design and Development Control
Company will address design and development control.
Design and Development Planning
- Divisional Managers will be responsible for making plans for each new design and development activity. The plan will describe the authority and responsibility of the personnel for each activity, reference standards and final approval etc.
- The design and development activities are assigned to the trained and qualified personnel. The design documentation will include the methods, assumptions, formulas and calculation.
- Organizational and technical interfaces of personnel involved in design and development will be identified, documented, transmitted and regularly reviewed.
- The design output will be updated as the design and development progresses.
Design and Development Inputs
The applicable design and development input requirements such as
- Functional and performance requirements.
- Statutory and regulatory requirements.
- Information derived from previous similar designs.
- Results of contract review etc will be identified, documented and reviewed.
- Incomplete, ambiguous or conflicting requirements shall be resolved.
Design and Development Output
Design and development output will be verified to ensure that
- Input requirements are met.
- Identifies characteristics crucial to the proper functioning of the product.
- Includes acceptance criteria.
- Translated in to instructions, procedures, working drawings, work orders, product specification, route card etc that includes acceptance criteria.
Design and Development Review
- The design and development output will be reviewed by the Technical Manager with similar design, alternate calculations, review of route card/work, order etc.
- The final design review will be conducted by the Department Managers for the design developed by the Technical Manager.
- Department Managers will ensure that records of design review are maintained.
Design and Development Verification
The design and development verification will be conducted and documented by the Technical Manager. To ensure that design stage output meets the input requirements. Design review will also be treated as design verification.
Design and Development Validation
Design and Development validation tests, on final product, trial production, field validation and validation tests as per API product specification will be conducted and documented.
Control of design and Development Changes
- Changes if any required in the design and development will be identified, documented and reviewed by the Department Managers and approved by the GM.
- Design changes will be controlled by the same functions as the original design.
- Technical Manager will carry out evaluation of design changes that affect the constituent parts and delivered product.
Purchasing
Purchasing Process
Procedure will address vendor approval.
- Selection criteria and evaluation of supplier/subcontractor will be based on their ability to meet the supply/subcontract requirements.
- Suppliers/sub-contractor will be verified for criteria such as past history, financial strength, technical capability, storage facility, machinery availability, personnel, transport facility, quality management system certification etc. Prior to approval and placement of order.
- List of approved vendors will be maintained.
Assessment of vendors
- The continuous compliance to the purchasing requirements will be assessed by one or more of the following listed methods.
a) Inspection of the final product at supplier’s/subcontractor’s premises.
b) Inspection of the final product at receiving inspection upon delivery.
c) Surveillance of vendor to comply company purchasing requirements.
d) Verification of the supplier’s/subcontractor’s quality system conformance.
Purchasing Information
- The purchase order will contain the complete details like, type class, style, grade, applicable specification, drawings, process requirements, inspection instruction, and requirement for approval of product, procedure, process, equipment, personnel and any other QMS requirements.
- The purchase orders will be reviewed and approved by GM or his deputy prior to release.
Verification of Purchased Product
Verification at Supplier/Subcontractor premises.
The verification arrangements and the method of product release will be mentioned in the purchase order. No material will be issued to production without carrying out receiving inspection.
Customer verification of Supplied/Subcontracted Product
The customer representative will be afforded the right to verify the product at supplier/subcontractor’ premises when specified in the contract.
The verification by customer will not absolve the responsibility of the company to supply acceptable product.
Production and Service Provision
Production/Service Control
Procedure will address project start up planning and control.
The production/service control is established through documented procedures to ensure that all operations are carried out in a controlled manner through the following:
- Documented procedures defining the manner of production/service.
- Compliance with standards, codes, quality plan with acceptance criteria.
- Use of appropriate equipment and working environment.
- Monitoring of process parameters and product characteristics.
- Qualification/approval of processes and equipment as appropriate.
- Preventive maintenance of equipment for continuing process capability.
- Criteria for workmanship.
The process control will be documented in drawings, process routing sheet, quality plan etc, listing the verification activities, reference standards/drawings, acceptance criteria, and inspection/hold points, methods for release, delivery and post delivery activities.
The personnel responsible for process control will be mentioned in process routing and inspection sheets.
Service Provision
The field servicing activities based on customer equipment, complaints will be documented, performed, monitored and verified conforming to customer requirements.
Validation of Processes – Special Processes
Capital Middle East LLC establishes the following processes when the resulting output cannot be verified by subsequent monitoring or measurement.
Post curing of GRE products
Capital Middle East LLC establishes specific method and work instructions. The process has been reviewed and approved on the defined criterion. The qualification of the personnel and equipment are approved and the required records are maintained and revalidated by the QA/QC In-charge as and when required.
Identification and Traceability
Procedure will address material/product identification and traceability.
- Identification and traceability will be maintained from receipt to delivery.
- Material/product identification as required by the supplier/customer/applicable product specification will be maintained.
- Control features for replacement of identification marks and records will be maintained.
Procedure will address inspection and test status.
- The inspection and test status of product is identified by stickers/labels at all the stage to indicate the conformance or non-conformance of product with respect to inspection and test performed.
- The identification of inspection and test status will be maintained from raw materials stage to delivery stage as defined in procedure to ensure that only the product that pass the required inspection and tests (or released under authorized concession) is dispatched used or installed.
Application and removal of API Monogram (PART 11)
- The API Monogram, license number and date manufacture will be applied to product in accordance with the marking requirements in API spec. as applicable with a marking procedure.
- The API Monogram will be applied only at the licensed facility after determining the conformity to the applicable API specified requirements and applied at final inspection.
- The QA/QC In-charge will be the authority for applying and removing of API Monogram.
- The API Monogram will be removed if the product is found to be in nonconformance with API specified requirements shall not bear the API Monogram.
Customer Property
- The customer supplied product/property provided for use or incorporation into the product/service will be identified, verified, protected and safeguarded.
The organization has established control features for verification, storage, maintenance and control of customer property.
- Lost, damaged or otherwise found unsuitable product will be reported to the customer and records maintained.
Preservation of Product
Procedure will address handling, storage, packaging, preservation and delivery of product.
Controls for Handling
- Suitable material handling equipment will be used to prevent damage or deterioration. All handling equipment will be regularly cleaned lubricated and repaired.
Controls for Storage
- Finished product/components/materials will be stored in warehouse for easy movement/receipt/dispatch and to prevent damage or deterioration.
- The stored items will be periodically monitored to ensure fitness for use.
- Documented records for receipt/dispatch from stores will be implemented.
Controls for Packaging
- The packaging and marking will be carried out as per the requirements of manufacturer/product/customer specification to ensure conformance.
Controls for Preservation
- Methods used for preservation and segregation of product until the dispatch of product will conform to product/manufacturer/customer specification.
Controls for Delivery
- Care will be taken for protection of the quality of product after final inspection and test. The protection is extended to delivery to destination where specified by the customer.
Control of monitoring and Measuring Devices
Procedure will address equipment calibration.
- All inspection, measuring and test equipment used will be identified and controlled to ensure compliance with the required measurement capability.
- The selection of the inspection measuring and test equipment is made on the basis of capability, accuracy and precision.
- All inspection measuring and test equipments are identified and calibrated at prescribed intervals as per the international or national standards. Where no such standards exist, the basis used for calibration shall be documented.
- The calibration details like equipment type, identification, location, frequency of checks, check method, acceptance criteria and the action to be taken when the results found unsatisfactory etc. are described in the documented procedure.
- Calibration status is indicated by a sticker or approved identification record. The calibration records are documented and maintained.
- The following actions are taken when the inspection measuring and test equipment is found out of calibration.
a) Examine the records and validity of last calibration.
b) Analyze the extent inaccuracy.
c) Re-check the product features.
d) Re-call the product, which was tested with, out of calibration equipment.
e) Re-apprise frequency of calibration for the particular equipment.
- The QA/QC In-charge will be responsible to ensure that the environmental conditions are suitable for the calibrations and storage of test equipment.
- The QA/QC In-charge will be responsible to ensure that the handling, preservation and storage of test equipment are such that the accuracy and fitness for use are maintained.
- QA/QC In-charge will safeguard inspection, measuring and test facilities including both test hardware and software from adjustment, which would invalidate the calibration setting.