Categories starting with R

Items starting with R

Root Cause Analysis Defined

Friday, 07 March 2014
ASR Editor
A convenient description for root cause would include the following three keys:
  1. It directly led to the issue, problem or failure. Taken by itself, this cause can clearly be seen as why things went wrong.
  2. If it had been eliminated or contained nothing bad would have happened. Eliminated or contained means that we should have known about it and planned for it, so something in our system needs to be identified and fixed.
  3. It can be clearly stated. Whatever we think the cause is, we can put it into words that everyone can agree with and understand.

Risk Based Thinking – And ISO 9001:2015

Tuesday, 15 September 2015
ASR Editor

ISO/FDIS 9001:2015

With the release of the 2015 revision, it is important to revisit one of the major changes to the standard – developing risk based thinking.

ISO 9001:2015 moves risk based thinking from a "should" or a good idea to enhance a QMS to a "shall" requirement. Both ISO 13485:2003 and AS9100 require users to address risk in Section 7 of their respective standards.

A good way to look at risk and to address risk is by utilizing the PDCA cycle - Plan, Do, Check and Act.

Risk Management - Advanced Product Planning for Industry

Friday, 07 March 2014
ASR Editor
Risk Management is part of ISO 13485:2003 and AS9100 Rev C.

These two standards need to be fully understood before an effectively implemented system can be developed. Some  type of risk management plan might be valuable for all manufacturing and service industries.

Root Cause and Corrective Action Tool

Friday, 07 March 2014
ASR Editor
Here is the beginning process on how to approach the corrective action process from properly identifying the problem statement to implementing irreversible corrective action.

These questions are great tools as you work through the root cause and corrective action process. They ask a series of questions and help guide you in the right direction. The content provided is as follows. If you would like some of the original laminated versions, please call us and we will send them to you.

Risk Based Thinking – New for ISO 9001

Wednesday, 29 July 2015
Rand Winters

ISO/FDIS 9001:2015

A final draft of ISO 9001:2015 has been released for a final vote. Official release of ISO 9001:2015 is expected shortly after the September 9th voting deadline. There may be a slight change in the final wording of the document following this final vote.

In advance of the 2015 release of ISO 9001 it is important to revisit one of the major changes to the standard – developing risk based thinking.

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Automotive

  • IATF 16949
  • Intl. Automotive Task Force
  • BS 25999
  • OHSAS 18001

Medical Devices

  • ISO 13485
  • Product Safety
  • Device Recalls
  • Emergency Situations

Aerospace

  • AS9100
  • AS9110
  • AS9120
  • SAE Technical Standards

Environmental

  • ISO 14001
  • EPA Regulations
  • EMS Tools
  • Emergency Preparedness