8.5.1、Control of production and service provision
The organization shall implement production and service provision under controlled conditions. Controlled conditions shall include, as applicable:
a. the availability of documented information that defines:
1. the characteristics of the products to be produced, the services to be provided, or the activities to be performed;
2. the results to be achieved;
NOTE 1: Documented information that defines characteristics of products and services can include digital product definition data, drawings, parts lists, materials, and process specifications.
NOTE 2: Documented information for activities to be performed and results to be achieved can include process flow charts, control plans, production documents (e.g., manufacturing plans, travelers, routers, work orders, process cards), and verification documents.
b. the availability and use of suitable monitoring and measuring resources;
c. the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met;
1. ensuring that documented information for monitoring and measurement activity for product acceptance includes:
—— criteria for acceptance and rejection;
—— where in the sequence verification operations are to be performed;
—— measurement results to be retained (at a minimum an indication of acceptance or rejection);
—— any specific monitoring and measurement equipment required and instructions associated with their use;
2. ensuring that when sampling is used as a means of product acceptance, the sampling plan is justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability).
d. the use of suitable infrastructure and environment for the operation of processes;
NOTE: Suitable infrastructure can include product specific tools (e.g., jigs, fixtures, molds) and software programs.
e. the appointment of competent persons, including any required qualification;
f. the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;
NOTE: These processes can be referred to as special processes (see 220.127.116.11).
g. the implementation of actions to prevent human error;
h. the implementation of release, delivery and post-delivery activities.
i. the establishment of criteria for workmanship (e.g., written standards, representative samples, illustrations);
j. the accountability for all products during production (e.g., parts quantities, split orders, nonconforming product);
k. the control and monitoring of identified critical items, including key characteristics, in accordance with established processes;
l. the determination of methods to measure variable data (e.g., tooling, on-machine probing, inspection equipment);
m. the identification of in-process inspection/verification points when adequate verification of conformity cannot be performed at later stages;
n. the availability of evidence that all production and inspection/verification operations have been completed as
planned, or as otherwise documented and authorized;
o. the provision for the prevention, detection, and removal of foreign objects;
p. the control and monitoring of utilities and supplies (e.g., water, compressed air, electricity, chemical products) to the extent they affect conformity to product requirements (see 7.1.3);
q. the identification and recording of products released for subsequent production use pending completion of all required measuring and monitoring activities, to allow recall and replacement if it is later found that the product does not meet requirements.