ASME QPS-2021 pdf – Quality Program for Suppliers: General Industry
ASME QPS-2021 pdf – Quality Program for Suppliers: General Industry.
(a) The preparation, approval, issuance, and change of internally established documents that specify quality requirements or prescribe activities affecting quality shall be controlled to ensure correct and approved documents are used. These documents shall be reviewed for adequacy and approval prior to release by authorized personnel. Changes to these documents shall be reviewed and approved by defined authorized personnel.
(b) Externally established documents, such as customer agreements, normative references, and standards, shall be reviewed for adequacy by authorized personnel prior to release as an approved document for use under the Certificate Holder’s quality program or the technical job file.
2-3.2 Competency Matrix
‘l’he competency matrix shall identify the types of documents and the individuals who meet the competency requirements to prepare, approve, and issue such documents for use under the Certificate Holder’s quality program.
2-3.3 Access to ControLLed Documents
(a) Measures shall be in place to ensure that the current version of approved documents are accessible and used as foil ows:
(1) by production personnel to achieve conformance
(2) by technical and quality personnel to verify the achievement of conformance
(b) The documents that shall be controlled under section 2-3, include, but are not limited to, the following:
(1) Quality Program Manual and subtier documents such as, but not limited to, procedures, work instructions, drawings, forms, tags, and labels
(2) technical job file
(3) ASME agreement and ASME certificate
(4) product specification document
(5) normative references, standards referenced under the quality program, customer agreement, and product specification document
(6) purchase orders
(7) competency matrix
(8) approved suppliers list
2-4 TECHNICAL JOB FILE REQUIREMENTS
There shall be a technical job file for each product produced under the Certificate Holder’s quality program that identifies the technical and quality requirements to be achieved and verified.
2-4.2 Preparation, Review, and ApprovaL of TechnicaL Job FiLes
(a) The technical job file shall be prepared by technical and quality personnel as a controlled document. Technical and quality personnel shall transcribe the technical and quality requirements of the product as specified in the original source specification, from either the customer agreement or a product specification, as process requirements. The technical and quality requirements shall be defined through, but not limited to, drawings, procedures, work instructions, process sheets, forms, travelers, labels, and tags. The personnel involved in performing the prescribed activities shall have access to these controlled documents, as appropriate to their job function and responsibilities.
(b) The technical job file shall identify the processes where credentialed personnel are required.
(c) Technical and quality personnel shall determine the type of inspections and testing (quality control activities) required to verify the achievement ofquality. The completed technical job file shall be verified by authorized personnel for accuracy and correctness to the original source specification for the product. The competency matrix shall identify personnel who satisfy the defined competency requirements to prepare, review, and approve the technical job file.
(d) Certificate Holders not performing or assuming design responsibility shall have technical personnel control use of the customer’s design documents, including customer approved changes, within its technical job file.
2-5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS
Activities affecting quality shall be prescribed by and performed in accordance with documented instructions, procedures, or drawings of a type appropriate to the circumstances. These documents shall include or reference appropriate quantitative or qualitative acceptance criteria for determining that prescribed activities have been satisfactorily accomp1 i shed.
2-5.2 Preparation, Review and Approving for Use
Documented instructions, procedures, internal specifications, or drawings shall be reviewed for adequacy and approved for release in accordance with section 2-3. The competency matrix shall identify personnel who meet the defined competency requirements to perform the prescribed activities.