Slide 84 of 262
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
NOTE: There are no new requirements in Control of Production and Service Provision from the 1994 version.
The company shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable......
The requirement contains much of the same requirements of 4.9, 4.10, 4.12 and 4.19 of the 1994 standard. Specifically 7.5.1 states that your company shall control production and services operations through:
a) Making information that specifies the characteristics of the product available;
b) Making work instructions available (where necessary);
c) Maintaining equipment for production and service operations;
d) Using measuring and monitoring devices;
e) The implementation of monitoring activities;
f) Implementing defined processes for release, delivery and post-delivery activities (where needed).
The above are particular conditions under which you should operate. By doing so activities will be carried out in a consistent way. It implies control over all the factors that affect your processes, including documented procedures, process parameters, process or product monitoring, operator qualification, personnel, materials and the processing environment.
I recommend the use of flow charts (process mapping) as a starting point for this requirement. Flow Charting your primary and secondary process will ensure that you have addressed all parts of your operations. Involve a team of people who are responsible for your product/services process(es) and a cross functional mixture of people who perform them. Identify and plan all processes that effect quality and then determine the controls necessary to ensure your processes are consistent. Remember, operations control deals with the value added parts of your business and the operational controls are different in EVERY company.
Potential Audit Question:
How does your company control production and services operations through:
a) Making information that specifies the characteristics of the product available?
b) Making work instructions available?
c) Maintaining equipment for production and service operations?
d) Using devices for monitoring and measurement?
e) Implementing monitoring devices?
f) Implementing defined processes for release, delivery and post-delivery activities (where applicable)?