Control of production and service provision in AS9100 standard
Control of production and service provision in AS9100 standard
Clause 7.5.1
Planning shall consider, as applicable,
- the establishment of process controls and development of control plans where key characteristics have been identified,
- the identification of in-process verification points when adequate verification of conformance cannot be performed at a later stage of realization,
- the design, manufacture, and use of tooling so that variable measurements can be taken, particularly for key characteristics, and
- special processes (see 7.5.2).
The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable
a) the availability of information that describes the characteristics of the product,
b) the availability of work instructions, as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement, and
f) the implementation of release, delivery and post-delivery activities,
g) accountability for all product during manufacture (e.g., parts quantities, split orders, nonconforming product),
h) evidence that all manufacturing and inspection operations have been completed as planned, or as otherwise documented and authorized,
i) provision for the prevention, detection, and removal of foreign objects,
j) monitoring and control of utilities and supplies such as water, compressed air, electricity and chemical products to the extent they affect product quality, and
k) criteria for workmanship, which shall be stipulated in the clearest practical manner (e.g., written standards, representative samples or illustrations).
7.5.1.1 Production Documentation
Production operations shall be carried out in accordance with approved data. This data shall contain as necessary
a) drawings, parts lists, process flow charts including inspection operations, production documents (e.g., manufacturing plans, traveler, router, work order, process cards); and inspection documents (see 8.2.4.1), and
b) a list of specific or non-specific tools and numerical control (NC) machine programs required and any specific instructions associated with their use.
7.5.1.2 Control of Production Process Changes
Persons authorized to approve changes to production processes shall be identified.
The organization shall identify and obtain acceptance of changes that require customer and/or regulatory authority approval in accordance with contract or regulatory requirements.
Changes affecting processes, production equipment, tools and programs shall be documented. Procedures shall be available to control their implementation.
The results of changes to production processes shall be assessed to confirm that the desired effect has been achieved without adverse effects to product quality.
7.5.1.3 Control of Production Equipment, Tools and Numerical Control (NC) Machine Programs
Production equipment, tools and programs shall be validated prior to use and maintained and inspected periodically according to documented procedures.
Validation prior to production use shall include verification of the first article produced to the design data/specification.
Storage requirements, including periodic preservation/condition checks, shall be established for production equipment or tooling in storage.
7.5.1.4 Control of Work Transferred, on a Temporary Basis, Outside the Organization’s Facilities
When planning to temporarily transfer work to a location outside the organization’s facilities, the organization shall define the process to control and validate the quality of the work.
7.5.1.5 Control of Service Operations
Where servicing is a specified requirement, service operation processes shall provide for
a) a method of collecting and analyzing in-service data,
b) actions to be taken where problems are identified after delivery, including investigation, reporting activities, and actions on service information consistent with contractual and/or regulatory requirements,
c) the control and updating of technical documentation,
d) the approval, control, and use of repair schemes, and
e) the controls required for off-site work (e.g., organization’s work undertaken at the customer’s facilities).
Related documents
Advertisement
Sponsor sites:
1. Phrases For Performance Appraisals.
2. Interview questions and answers.
This entry was posted
on Monday, January 18th, 2010 at 3:28 pm and is filed under AS 9100 standard.
You can leave a response, or trackback from your own site.
