The 9000 Resource

How is 7.5.1 “Control of production and service provision” different from 7.1 “Planning of product realization”?

In 7.5.1 the requirements focus on the processes that actually create your hardware or your service that is delivered to your customers. You are required to follow the plan that you created based on requirements in 7.1

A written procedure for this section will be useful in defining how you are meeting these requirements. By clearly documenting the way that you are satisfying the requirements of 7.5.1 you will ensure that the requirement are understood and followed consistently.

Most organizations will also need documentation in the form of work instructions to control these processes. Your planning in 7.1 will determine where these are needed; to meet the requirements of 7.5.1 these must be in place, available to employees performing the process. Instructions can take many different forms: written steps, pictures, drawings, prints, travelers or flow charts are some of the methods used. Specify in your procedure what documents are necessary for the control of your processes.

The procedure should also state how you ensure that suitable equipment is used, and how release, delivery and post-delivery activities are controlled.

What are Corrective and Preventive Actions?

Corrective and Preventive Action are actions taken to address nonconformities and their root cause and to prevent the nonconformance from reocurring. This is a key part of your ISO 9000 continual improvement process.

Corrective and Preventive Action Procedures which you can use in your system. They describe the process for eliminating the cause of nonconformances through the use of a corrective action system and the process for eliminating the potential causes of nonconformances through the use of a preventive action system.

Corrective and Preventive Action Forms are used for documenting and tracking corrective and preventive actions and the actions taken.

The Corrective Action Procedure describes the process for eliminating the cause of nonconformances through the use of a corrective action system. Includes the process for initiating a corrective action request (CAR). (Any employee should be able to initiate a CAR.) Follow the process for tracking, investigating, implementing corrective action, following up and closing corrective actions. We also recommend including a step of reporting to Management Review.

The 9000 Store has a separate procedure for Preventive Action instead of combining it with Corrective Action because we have found that auditors interpret the standard to mean that separate, individual procedures are required. The Preventive Action Procedure describes the process for eliminating the potential causes of nonconformances through the use of a preventive action system. The Corrective Action and Preventive Action Procedures & Forms are sold as a set at The9000Store and are also available in the Quality Manual and Procedures Package.

Control of Production and Service

In section 7.1 you are asked to plan for all of your product realization processes, including processes that do not result in the product or service that is delivered to the customer (customer-related processes, design and development and purchasing). Planning included identifying things like:

Documentation Requirements

Resources

Measuring and monitoring activities

Inspection and test activities

Product criteria

Records required

In 7.5.1 the requirements focus on the processes that actually create your hardware or your service that is delivered to your customers. You are required to follow the plan that you created based on requirements in 7.1

A written procedure for this section will be useful in defining how you are meeting these requirements. By clearly documenting the way that you are satisfying the requirements of 7.5.1 you will ensure that the requirement are understood and followed consistently.

Most organizations will also need documentation in the form of work instructions to control these processes. Your planning in 7.1 will determine where these are needed; to meet the requirements of 7.5.1 these must be in place, available to employees performing the process. Instructions can take many different forms: written steps, pictures, drawings, prints, travelers or flow charts are some of the methods used. Specify in your procedure what documents are necessary for the control of your processes.

The procedure should also state how you ensure that suitable equipment is used, and how release, delivery and post-delivery activities are controlled.