The Certified Quality Process Handbook 2nd edition Ch. 1: pp The Certified Quality Process Handbook 2nd edition Ch.1: pp.10-13 Quality Documentation Chapter 5 (1st edition) Presented by Dr. Joan Burtner Certified Quality Engineer Associate Professor and Chair Dept. of Industrial Engineering and Industrial Management Mercer University

Three Purposes of an Organization’s Documentation System Guide individuals in the performance of their duties Standardize the work processes throughout the organization Provide a source of evidence regarding practices The authors observe, “Failure to standardize is one of the most prevalent reasons for confusion and friction in processes involving multiple departments, functions, or teams.” (CQPA Handbook, 2nd edition, page 10) IDM355 Fall 2016 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

ISO 9001:2000 Standards Registered organizations must possess an extensive documentation system (paraphrased) 4.2.3 Control of Documents Quality management system (QMS) documents must be controlled. A documented procedure must be established to approve, review, update, and identify the current revision level of QMS documents. 4.2.4 Control of Quality Records The organization must control and maintain QMS records to provide evidence of conformance to requirements …. IDM355 Fall 2016 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

ISO 9001:2008 Standards (p.11 2nd ed) Registered organizations must possess an extensive documentation system (paraphrased) 4.2.3 Control of Documents Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4. 4.2.4 Control of Quality Records The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records. IDM355 Fall 2016 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

Configuration Management Configuration management is a discipline and a system to control changes that are made to hardware, software, firmware, and documentation throughout a system’s lifecycle (CQPA Handbook, 2nd edition, page 323) The purpose of the configuration management system is to ensure that changes to specifications, installation instructions, drawings, training materials, etc. are systematically changes in every document that contains those items. A configuration control board (CCB) is often established to administer the configuration management system A document traceability matrix is often used to identify requirements and the corresponding document names and numbers IDM355 Fall 2016 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

Documentation Control Documentation control is a system used to track and store electronic documents and/or paper documents (CQPA Handbook, 2nd edition, page 331) Many document control systems discourage the use of hard copies (printed paper) documents. It is believed that the use of hard copies is often associated with the use of out-of-date forms. IDM355 Fall 2016 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering

Questions/References “ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.” “ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.” http://asq.org accessed 10/16/15 IDM355 Fall 2016 Dr. Joan Burtner, Assoc. Prof. and Chair, Dept. of Industrial Engineering