Rand E. Winters

Where’s Your Action List?

Monday, 16 February 2015
Rand Winters
change mgmtChange management is a small segment in the forthcoming revised ISO 9001 and for many organizations adjusting their system to address the 2015 version of ISO 9001 can be made a little easier with the appropriate tool.

As I audit organizations, I am amazed at the lack of action lists to monitor multiple tasks to be accomplished in the near future. An action list on a spreadsheet can be a valuable reminder of the projects and resources needed.

ISO 14001 – Foundation for Becoming Green

Wednesday, 15 December 2010
Rand E. Winters - ASR Lead Auditor
Green Living for Dummies states that becoming "green" means taking action now to stop using the Earth's resources faster than the Earth can replace them.

Defining Design and Design Responsible

Thursday, 17 April 2014
Rand E. Winters - ASR Senior Auditor
ASR technical personnel are periodically asked to define "Design" and what criterion determines "Design Responsible."

Pushing Continual Improvement

Tuesday, 24 June 2014
ASR Editor
An effective audit program pushes an organization’s continual improvement process. Here is a quick review of the key parts and pieces of an internal audit system that an outside auditor investigates during their visit. How does your firm stack up?

CQI-11 and CQI-12 – New Mandates For North American Automotive

Friday, 17 December 2010
Rand E. Winters - ASR Lead Auditor
These two self-assessments were developed by AIAG to promote improved and uniform quality and processes for plating (CQI-11) and coating (CQI-12) operations. Both self-assessments were effective January 2008 for first tier suppliers to GM, Ford and Chrysler.

Sort, Store, Shine, Standardize, Sustain (5S)

Friday, 15 May 2015
ASR Editor
Something to Think About
By Rand Winters
ASR Senior Auditor

In recent years, a number of ASR clients have started lean manufacturing programs without considering a full blown 5S program.

AIAG’s CQI-9 Special Process: Heat Treat System Assessment

Wednesday, 15 April 2009
Rand Winters, ASR Auditor
CQI-9 is now an ISO/TS 16949 customer requirement of Ford, General Motors and DaimlerChrysler. CQI-9 was written by AIAG and is aimed at automotive suppliers who purchase heat-treating and heat treaters servicing the automotive industry.

Presentation - A Review ISO 9001:2015 (Revision Update)

Monday, 07 April 2014
Rand E. Winters - ASR Lead Auditor
Overview of the changes to the ISO 9001 standard.

Determining Adequate 2015 Documentation

Wednesday, 29 July 2015
Rand Winters
Revision writers left it up to organizations determine how many and what procedures and work instructions to document. This vague approach to documentation opens the door for each organization to develop a system that reflects what works best for them.

Final voting on the 2015 revisions concludes in September and there may be some slight language changes.

Two types of documented information (ISO 9001:2015 4.4.2) are required. Organizations will have to maintain documented information (procedures and work instructions) and they will have to retain documented (records) information.

Opportunity for Improvement - A Benefit

Wednesday, 15 December 2010
Rand E. Winters - ASR Lead Auditor
An Opportunity for Improvement (OFI) is a pretty neat idea! It allows your ASR auditor to share with you valuable ideas that may be helpful as your organization pushes its quality management system for continual improvement.

In fact, a well-thought out Opportunity for Improvement in many cases may be of more value than a well-implemented non-conformance.

What is the definition of an OFI as listed in ASR's auditing procedure?

ISO 9001:2015 – On its Way

Wednesday, 08 October 2014
ASR Editor
A major rewrite draft of ISO 9001 is circulating through the voting stage. If the latest draft is approved, release is expected in the 4th quarter of 2015 following a final vote sometime mid 2015. Implementation deadline is three years from date of approval making it in a 2018 – 2019 timeframe.

Medical Device Makers and Component Suppliers Software Validation Reminder

Thursday, 15 November 2012
Rand E. Winters - ASR Senior Auditor
Medical device manufacturers will want to review their QMS documents to ensure they are addressing software  validation requirements.

ISO 9001:2008 -7.5.2.1 and the FDA requirements in 21 CFR 820.30 and 21 CFR 820.70i spell out validation requirements for software design as well software in the production environment.

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.

ISO 9001:2015 - Takes Aim at Risk Management

Wednesday, 08 October 2014
ASR Editor
ISO 9001:2015 (draft) revision writers thought organizations might reap greater benefits if preventive action was included as part of a formalized risk management system.

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