Process Control By: Neal Stiemert Process Control One of the requirements of the ISO 9001:2000 standard is process control (called control of production and service provision in the 2000 standard). Control of our manufacturing and service processes are vital if we are to produce a consistent product. As an auditor, I write a very large number of audit findings against process control. Typical audit findings are: No instructions available No maintenance on equipment Inspection, measuring and test equipment not calibrated Written instructions not being followed Personnel not trained Machine settings not in accordance with established parameters Nonconforming product not identified Critical characteristics not being verified Documents being used of the wrong revision ISO Requirement: (Key requirements are italicized) 7.5.1 Control of production and service provision The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable: the availability of information that describes the characteristics of the product; Example: Information can be quality plans, inspection plans specifications of drawings. the availability of work instructions, as necessary; Example: If needed, have work instructions available. If the personnel are trained, they may not be needed. the use of suitable equipment; Example: If you make jewelry, don't use a pipe wrench and sledge hammer for manufacturing tools the availability and use of monitoring and measuring devices; Example: Have the necessary devices to monitor the process and inspection, measuring and test equipment to verify quality characteristics. the implementation of monitoring and measurement, and; Example: Monitor the process and verify the product quality characteristics at intervals defined in the procedures and/or control plan. the implementation of release, delivery and post-delivery activities. Example: Only release product that conforms to specifications, control the delivery (shipment) process and have a process to control post-delivery activities such as installation of a computer system or, a large screen TV. Section from a typical Quality Manual 7.5    Production and Service Provision Control or Production Service Provision Acme controls production and service operations through: the availability of documentation that describes the characteristics of the product where necessary, the availability of work instructions the use of suitable equipment the availability and use of measuring and monitoring devices the implementation of monitoring and measurement activities the implementation of release, delivery and post-delivery activities Summary Please remember…the existence of your company is dependent on our ability to deliver quality products and services that get to our customer on time. How well we plan and control our processes are vital. During audits, the auditors tend to focus on the production activities to evaluate how well you can produce products and services that meet customer requirements. I hope this information helps you with your transition. Feel free to contact me with any questions at 800-959-0632. Neal Stiemert President Independent Quality Consultants, Inc. About the Author Neal D. Stiemert is President of Independent Quality Consultants, Inc. and holds a Bachelor of Science degree from Indiana University school of business. Neal is an ASQ Certified Quality Engineer, a certified lead auditor and has over 24 years of management, auditing, consulting and training experience in the quality profession. Neal has served as an examiner for the Minnesota Quality Award, an SPC instructor at Purdue University and an officer and committee member in the Chicago and Minnesota sections of ASQ. Neal also conducts registration audits for Smithers Quality Assessments and SAI Global Assurance Services. Comment on this article