Where to Begin When Starting Over?

I am currently working with a manufacturing facilities to reinstate its Quality Management System (QMS). This happens to be one of three facilities in our organization for which I am the Director of Quality; as such, I am also the ISO Management Representative. Let's not dwell on the silly reasons this organization was allowed to fall into such disarray. Needless to say, it could not be avoided. Under new management, however, we have an opportunity to breathe new life into this facility's QMS.

For the lay person reading this post, a Quality Management System (QMS) is a collection of policies, procedures, and processes adopted by an organization in order to implement quality management. ISO9001 is an international standard for quality management which helps ensure an organization meets the requirements of its customers and other stakeholders. The organization above has an ISO9001-based QMS.

One question: Where to begin?

Sometimes it's best to start over and by starting over I mean start from scratch. Starting from scratch can make a dramatic impact. This is the case with this particular organization. In this case only a couple very dedicated employees had accepted responsibility for the organization's QMS. Most of the other 35 employees are not aware the organization is still ISO9001 registered. This is about to change.

Since the basis for an ISO9001-based QMS is the process approach to managing an organizations as a system of interrelated processes, we need to start with identifying the organization's core processes.  Examples include the Sales Order Process, Order Fulfill Process, Purchasing Process, Project Management Process, Quality Planning Process, etc. Once identified, we need to assign ownership for these processes. Everyone in the organization works in one or more of these processes and has a role to play.

No longer does the burden for the QMS fall on just a couple dedicated employees. The managers who were not previously engage in the QMS are now process owners.  Process owners are responsible to establish, document, and maintain their respective process and work to continually improve its effectiveness and interaction with other processes.

This is where we begin. Then to sustain these changes we audit.  We audit the process to ensure each has an approach that is deployed where needed, delivers intended results, and is continually improved. We also audit process results to ensure the process has key performance indicators, tracked levels of performance, and positive trends.

This is where we begin when we must start from scratch. Then once the leadership fully embraces and masters the process approach by managing the organization as a system or interrelated processes the rest of the QMS requirements are relatively easy to deploy.

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