Welcome to August 2014 edition of Carnival of Quality Management Articles and Blogs.
We have had a fairly good look at the world of nonconformance in the previous editions of the blog carnival. [Blog Carnival Edition of March 2014) /: Blog Carnival Edition of April 2014), Blog Carnival Edition of May 2014, Blog Carnival Edition of June 2014) and Blog Carnival Edition of July 2014].
The next logical step is to address the nonconformance. Correction, Corrective Action and Preventive Action are the most usually traversed paths for this purpose.
We dedicate the present edition of our Blog Carnival to Correction, Corrective Action and Preventive Action.
Correction is taken to rectify a known non-conformance; Corrective Action is taken to prevent recurrence of said non-conformance.
Related Articles and Dictionary Terms:
Corrective vs. Preventive Action by Russ Westcott
[ISO 9001] section 8.5.2 says corrective action eliminates the cause of nonconformities to prevent recurrence, and section 8.5.3 says preventive action determines and eliminates the causes of potential nonconformities … to prevent occurrence.
One way to dispel these is by separating situations into … a patch (a single occurrence of a nonconformity that involves little risk and needs not be recorded), a corrective action (a more serious nonconformity involving some risk that requires action to prevent recurrence and must be recorded), a preventive action (a process that can be improved to prevent occurrence of a nonconformity and is to be documented) or a developmental action (a planned change to introduce a new process or product in response to strategic objectives, documented as a preventive action).
Corrective and preventive action (CAPA, also called corrective action / preventive action, or simply corrective action) are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice (GMP), and numerous ISO business standards. It focuses on the systematic investigation of the root causes of identified problems or identified risks in an attempt to prevent their recurrence (for corrective action) or to prevent occurrence (for preventive action).
Corrective actions are implemented in response to customer complaints, unacceptable levels of product non-conformance, issues identified during an internal audit, or adverse or unstable trends in product and process monitoring such as would be identified by SPC. Preventive actions are implemented in response to the identification of potential sources of non-conformity.
To ensure that corrective and preventive actions are effective, the systematic investigation of the root causes of failure is pivotal.
What is a Corrective Action Plan? – Definition, Procedures & Examples – A corrective action plan is a document describing exactly how a specific situation will be changed to better meet the goals of the company.
Monitoring corrective action – The table [in the article] illustrates the various steps that are taken by Electrolux when cases of non-compliance are found in our supply chain. Findings are graded in order of severity and range from Acceptable Findings to Zero Tolerance issues.
Corrective Action Challenge – How to construct a robust problem-solving process – R. Dan Reid
Recent data for ISO Technical Specification (TS) 16949 global certification audits show that clause 8.5.2, corrective action, is the one most frequently cited for major nonconformities, and it’s eighth on the list for minor ones.
In addition to the ISO 9001 requirements, ISO/TS 16949 requirements for this clause include sub-elements for:
- Problem solving.
- Error proofing.
- Corrective action impact.
- Rejected product test and analysis.
Clause 220.127.116.11 of ISO/TS 16949 requires that organizations "have a defined process for problem solving, leading to root cause identification and elimination."
Step 1: Clearly state the problem or weakness, including the root cause.
Step 2: List the individuals who will be accountable for the results of the corrective action
Step 3: Create simple, measurable solutions that address the root cause
Step 4: Each solution should have a person that is accountable for it.
Step 5: Set achievable deadlines
Step 6: Monitor the progress of your plan.
One post of an edition of blog carnival cannot ever do full justice to a wide gamut of methods and issues related to Correction, Corrective Action and Preventive Action. So, we will take note of a few, additional, representative articles here:
- Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes
- CAPA (Corrective Actions and Preventive Actions)
- Preventive / Corrective Actions (CAPA) Guidelines – R. M. .
- Corrective Action Preventative Action
- Corrective Actions
- Risk-Based Corrective Actions for Petroleum Hydrocarbon …
- CAPA within the Pharmaceutical Quality System
- safety audit corrective action plan – Alabama Department o
- The Corrective Action Handbook: Denise E. Robitaille …
We turn to our regular sections now:
ASQ Influential Voices bloggers are sharing their thoughts on the benefits of blogging and social media use–and where to start if you’re interested in doing the same, in Learning About Social Media With ASQ Bloggers. And for a deeper dive into the hows and whys of blogging, please read the article “Blog Boom” in July Quality Progress. It’s an in-depth conversation with ASQ Influential Voices bloggers Dan Zrymiak, Jennifer Stepniowski, Mark Graban, Jimena Calfa, and John Hunter.
In Establishing a Culture of Excellence: A Conversation With Arun Hariharan, is about key lessons in establishing a culture of continuous permanent improvement.
Blogger Round Up for July 2014, What’s the Purpose of Vision? is the ASQ’s Influential Voices bloggers’ response to a prompt about the clarity of focus at Volvo and Ikea and their thoughts on how to achieve and articulate an organizational purpose.
ISO 9001 Helps Soccer Team Improve All-Around – Monarcas Morelia, a team in the Mexican Football Federation, was finishing in the bottom of its league and losing money. In this video, learn how it turned things around by implementing a quality management system and becoming ISO 9001 certified. Read the full story
Our ASQ’s Influential Voice for the month is – Dr. Michael Noble
Dr. Michael Noble writes the Making Medical Lab Quality Relevant blog. He is a medical microbiologist within the Department of Pathology and Laboratory Medicine in the University of British Columbia, Vancouver, Canada. Dr. Noble is a self-declared "medical qualitologist" actively involved in national and international standards development, and is a provider of quality-oriented education and laboratory quality assessment.
Making Medical Lab Quality Relevant is a “discussion site for folks interested in improving the quality of medical laboratories. Most will be the thoughts and vents of a long time player in the medical laboratory quality from many perspectives, complex and basic laboratories, developed and developing countries, research and new knowledge.” The site has
We do not have a fresh insight this month in so far as Curious Cat Management Improvement Carnival category is concerned.
However , in such an event, we do pick up an interesting article posted recently. We pick up Children are Amazingly Creative At Solving Problems for our present edition.
“Preschoolers are curious about almost everything. Postschoolers are curious about almost nothing.” – Russell Ackoff
Related: Taking Risks Based on Evidence – Naturally Curious Children – Learn by Seeking Knowledge, Don’t Only Learn from Mistakes – Encouraging Curiosity in Kids – Extrinsic Incentives Kill Creativity
I look forward to your active participation in enriching the blog carnival as we pursue our journey …………….