The development of a Quality Management System or an Integrated Management System should not be a “tune up” of a canned presentation.  This should be the culmination of a cross functional and cross organizational effort.

Design:  The structure can be fairly well defined.  The content is determined by the organization.

Document:  The time to codify content is directly related to the number and complexity of the organization.  This step should not be rushed.  Buy-in from cross functions and cross organizational units is critical to the implementation.  Also, the complexity of the organization, its customers or product lines will determine the amount of commonality within the system.  Often times, the overall system (the What part) has greater differences in the Standard Work (the How pieces).

Implementation:  The method for implementation varies by organization.  The roll out could be done in any manner from a portion rolled out across all operational units at once, to an entire system roll out at one site and then replicated for all others.  The choices here are determined by the management team and agreed to by the operational units.  A key constraint is often the need to register the QMS or a customer request/requirement.

Controls:  From Document Control to training, controls ensure the system is documented, implemented and operational.

Audits and Metrics:  There are three (3) basics of management, 1). Set expectations.  2). Observe behavior.  3). Provide Feedback.  Using the QMS is the expectation.  Observation can be accomplished by auditing the system, processes or operations and it can be accomplished using various metrics (often times PPM, Customer Complaints, OTD, OEE as well as fiscal performance metrics). 

Analysis:  There is a temptation to use too much data.  This could result in data paralysis.  Following Dr. Deming’s example, analyze the Critical Few.  Provide distinct interpretation of data and make recommendations for areas to be reviewed.

Feedback and Improvement:  Using the PDCA, where the audits and/or metrics highlight a deficiency, conduct a robust Corrective Action process to improve the system.