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Efficient Transition for an Effective System

Presenter: Kristin Case, Consultant, CaseConsults, Tulsa, OK, USA

Keywords: Transition, Senior Leadership, Process Knowledge, Project Management

Industry: Aviation/Space, Manufacturing, Service

Level: Intermediate

ABSTRACT

This transition plan will provide attendees a simple map for efficiently transitioning to ISO 9001:2015 while making their QMS more effective. It requires a facilitator (typically the “management representative”) as well as senior leadership, process owners, and internal auditors. The work happens simultaneously, but the core steps include:

SENIOR LEADERSHIP.

• Define the context (clauses 4.1, 4.2, 4.3, 4.4.1b)

• Define how to measure the performance of the QMS (clauses 9.1 and 6.2)

• Implementing a risk mitigation plan that addresses “big picture” risk (clause 6.1)

• Can leaders demonstrate their commitment? (clause 5)

PROCESS OWNERS. Process owners will be a part of small teams, tasked with understanding key processes and the following is determined / required for each key process:

• the inputs and outputs

• the criteria and methods

• the resources required

• responsibilities and authorities

• performance measures are in place to evaluate the process

• risks and opportunities are addressed

• a cycle of continual improvement is designed in to the process

INTERNAL AUDITORS

Internal auditors perform gap analyses on processes not addressed by senior leaders or process owners. The order of these internal audits (along with the rationale for the order) will be presented. Each finding will require corrective action, but in many cases the root cause analysis will be fairly simple.

SUMMARY

The activities of senior leadership, process owners, and internal auditors occur simultaneously and require some basic project management (primarily by the facilitator). Primary benefits include speed of transition; involvement and understanding of senior leaders; and greater process understanding for all involved.