8.1、Operational planning and control
The organization shall plan, implement and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by:
a. determining the requirements for the products and services;
NOTE: Determination of requirements for the products and services should include consideration of:
—— personal and product safety;
—— producibility and inspectability;
—— reliability, availability, and maintainability;
—— suitability of parts and materials used in the product;
—— selection and development of embedded software;
—— product obsolescence;
—— prevention, detection, and removal of foreign objects;
—— handling, packaging, and preservation;
—— recycling or final disposal of the product at the end of its life.
b. establishing criteria for:
1. the processes;
2. the acceptance of products and services;
NOTE: According to the nature of the product and depending on the specified requirements, statistical techniques can be used to support:
—— design verification (e.g., reliability, maintainability, product safety);
—— process control;
selection and verification of key characteristics;
process capability measurements;
statistical process control;
design of experiments
—— failure mode, effects, and criticality analysis.
c. determining the resources needed to achieve conformity to the product and service requirements and to meet on-time delivery of products and services;
d. implementing control of the processes in accordance with the criteria;
e. determining, maintaining and retaining documented information to the extent necessary:
1. to have confidence that the processes have been carried out as planned;
2. to demonstrate the conformity of products and services to their requirements.
f. determining the processes and controls needed to manage critical items, including production process controls when key characteristics have been identified;
g. engaging representatives of affected organization functions for operational planning and control;
h. determining the process and resources to support the use and maintenance of the products and services;
i. determining the products and services to be obtained from external providers;
j. establishing the controls needed to prevent the delivery of nonconforming products and services to the customer.
NOTE: One method to achieve operational planning and control can be through using integrated phased processes.
As appropriate to the organization, customer requirements, and products and services, the organization shall plan and manage product and service provision in a structured and controlled manner including scheduled events performed in a planned sequence to meet requirements at acceptable risk, within resource and schedule constraints.
NOTE: This activity is generally referred to as project planning, project management, or program management.
The output of this planning shall be suitable for the organization’s operations.
NOTE: As an output of this planning, documented information specifying the processes of the quality management system and the resources to be applied to a specific product, service, project, or contract can be referred to as a quality plan.
The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.
The organization shall ensure that outsourced processes are controlled (see 8.4).
The organization shall establish, implement, and maintain a process to plan and control the temporary or permanent transfer of work, to ensure the continuing conformity of the work to requirements. The process shall ensure that work transfer impacts and risks are managed.
NOTE: For the control of work transfer from the organization to an external provider, or from an external provider to another external provider, see 8.4. For the control of work transfer from one organization facility to another, or from an external provider to the organization, see 8.5.