ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

7.5.1 Control of Production and Service Provision

ISO 9001 Training - Key Explanation Points and Tips:

This clause provides a list of control requirements that you may use, if applicable to your business.

Identify and control all production processes as per clause 4.1; 7.l and 7.5. Show the interaction of these processes with other processes. Use your product, project or contract quality plan to control production and service activities.

Schedule your production taking into consideration customer delivery requirements; production capacity and capability; material availability and usage; personnel availability and usage; storage; etc. Use appropriate MRP; ERP and other tools to manage this effectively and efficiently.

Carefully define and document the interaction of your production scheduling process with your logistics processes such as inventory management; customer communication; traffic and shipping control; packaging and labeling; sales and billing.

Use quality plans to control your production processes. Quality plans address what has to be made; how much has to be made; when it has to be made; by whom; in what sequence; how it has to be made; what production equipment to use; what measurement and monitoring tools to use ; what to inspect; when to inspect; how much to inspect; what to do if problems arise, etc. Your quality plan can exist in any media and cna comprise a simple shop order with related drawing for a small business to MRP/ERP software that drive complex manufacturing systems for larger organizations.

Work instructions may be viewed as a subset of your quality plan and may relate to a specific task or activity of your overall product realization process (e.g. setting up a machine; performing an inspection; packaging a product). If you determine that work instructions are needed at specific points in your process, then they must be readily available and relevant i.e. current or right version (see clause 4.2.3d). Note that work instructions may exist in many forms - narrative; graphical; audio; video; physical display; etc.

To improve your QMS, it will be very useful to draw a flow chart to link the flow and interaction of the activities and sub-processes covered by these clauses, e.g. many organizations overlook reviewing and updating their quality plans for corrective action taken to address a manufacturing process problem.

Your quality plan must cover all production process steps from - receipt of materials, production, packaging, storage, delivery and even post-delivery activities such as installation or training.

Your quality plans are dynamic and must be updated for the changes in product specifications or process parameters; resources used; monitoring or measurement requirements, etc. Your quality plans should reference any work instructions specified for the process steps. 

Production personnel must have timely access to all information relevant to their activities including specific work instructions if necessary. There may be serious risk to production flow, if such information is unavailable or untimely.

Clause 7.5 does not require a ‘documented’ procedure. However, you must identify and document all processes addressing this clause as part of your QMS (see clause 4.1). For these processes, you must also identify what specific documents are needed for effective planning, operation and control of production activities. These documents may include - a product quality plan; work instructions; documented procedure; etc., combined with unwritten practices, procedures and methods. Look at the risks related to your product, processes and resources in determining the nature and extent of documented controls you need to have (also see clause 4.2.1 notes).

Performance indicators (to measure the effectiveness of production processes in meeting requirements and achieving quality objectives) should focus on reducing variation in and improving production processes and related use of resources.

Indicators for production processes be product or process related. Product related indicators may include - reduction in defect rates, PPM’s (defective parts per million), scrap rates, waste and rework; improvement in on time delivery (see clause 7.1a). Production process related indicators may include - reduction in set-up time; run rates; process cycle time; production scheduling and operator errors and omissions; etc.