We don’t need no stinkin’ plan

Continuing on with the AS9100D “shall series”…

6.0 PLANNING

Actions to Address Risks and Opportunities

When planning for the quality management system, the organization shall determine the risks and opportunities that need to be addressed.Planning

The organization shall plan actions to address these risks and opportunities, integrate and implement the actions into its QMS & evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

Quality Objectives

The organization shall establish quality objectives at relevant functions, levels, and processes needed for the quality management system.

The quality objectives shall:

  • be consistent with the quality policy
  • be measurable
  • consider applicable requirements
  • be relevant to customer satisfaction
  • be communicated & updated as needed
  • be updated, as appropriate

The organization shall maintain documented information on the quality objectives, determining:

  • what will be done;
  • what resources will be required;
  • who will be responsible;
  • when it will be completed;
  • how the results will be evaluated.

Planning of Changes

When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner.

 

Plain English Translation

This planning requirement is about the QMS (operations planning is later). Risk is a key new component prevalent throughout the standard. Here it is relative to the identifying risks and opportunities in the QMS. Part of that process is developing Quality Objectives; the rules are; anything labeled as a quality objective must be have a metric in place to measure progress against the goal, and actions taken when they are missed. My typical guidance is to keep to 3-5. The unwritten rule is that two of the quality objectives must be measuring OTD & quality. The last part is owners, milestones & other resources need to be defined for each quality objective.

 

Contact me to see how I can help you develop your QMS Planning process for ISO 2015 or AS9100 2016 as painlessly as possible in your company.

920-841-3478

Steve@TheRightApproachConsulting.com

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