Super User

Super User

Friday, 30 October 2009 17:03

Why do root cause analysis...

I'm often told "We fix the cause of any complaints or returns - isn't that the same thing?"  Unfortunately there is a dramatic difference between an immediate correction to a failed product or service and doing root cause analysis to help you make lasting corrective actions which will prevent recurrence.

Whether the failure is related to a product or service, fixing the  surface cause of the individual occurrence (e.g., rework the part, replace the document, or call and clarify the miscommunication) may relieve the pressure temporarily, but it doesn’t really find out why it happened.  And the problem with quick fixes is they often turn out to be short-term, which leaves you open to repeat failures.

Monday, 09 November 2009 16:58

The Purpose of Quality Objectives

My auditor says we need Quality Objectives.  What are they and why do we need them?


There are all types of quality objectives – from top management strategic objectives, to in-line production objectives. In each case the goal is to create continual improvement within the QMS by identifying something to shoot for and then measure how you are doing against the objective.  Set by top management at relevant levels within the company, quality objectives are an expression of how the company intends to achieve its quality policy.  Quality objectives should be measurable, specific, and communicated, since employees need to understand how they contribute to them.  Quality objectives should not be limited to product quality, but be goals designed to help drive continual improvement of the entire Quality Management System (including resources, staffing, sales & marketing, production, measurement, analysis and improvement).


In our changing economy, staying the same is not an option – Strategic measurable quality objectives help everyone catch the vision and have specific targets to work towards.  One last reminder - to keep employees engaged and contributing, remember to measure progress against your objectives, and communicate status updates -- and find fun ways to recognize progress.

Thursday, 27 May 2010 16:56

Corrective Action vs. Preventive Action

There is a lot of confusion within the quality industry, and especially new companies about these two actions.  Part of the reason is that ISO 9001:2008 (and its predecessor 9001:2000) describe their associated activities in a similar structure, with a couple of key wording differences... We'll discuss the specific actions in a later blog.  For now lets clear the confusion of terms.
Over the last 10 years I have audited many small companies that hired consultants to perform their internal audits for them, so that they could meet their ISO 9001 audit requirements. Using an external consultant to reboot a failing system can be highly beneficial to overwhelmed staff. However, while auditor objectivity is indeed enhanced by using external auditors, someone internal must be responsible for ensuring complete follow through of any findings. The level of longterm effectiveness is dependent on company culture and management commitment to improve the QMS. I have rarely seen it work for small companies over the long term, for a couple of reasons:
Friday, 02 July 2010 16:51

Nonconformities vs. Corrective Actions

"It's just a rework - don't make me do a Corrective Action form - the paperwork will take longer than the fix"....  Ever heard that??? There's a huge difference between NonConformities and Corrective Actions, but if you are the type of company who gets a customer return, and they demand a corrective action every time, you've probably come to dread these concepts.  Lets step back from the viceral "I hate paperwork" reaction that we all have for just a minute, and discuss the uses and purposes for nonconformities and corrective actions. There are many things that could potentiall fall into the NonConformity  (NC)category -especially since ISO defines a NC as "non-fulfillment of a requirement" - but for most of us, it breaks down to:
Maintaining employee involvement in continuous improvement is all about corporate culture. If top management, managers, and supervisors are not routinely involved in addressing audit findings and driving improvement projects, it is all too easy for the QMS to have insufficient support to be more than compliance busy work.  ISO 9001:2008 says in the section for internal audits (8.2.2) that “management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes”.  This sentence emphasizes several  potential weaknesses to the effectiveness of any audit program:
    • Management attention to audit findings  --  see earlier blog
What do you think of when asked if you do design--engineers? Original concept development? What about processes development? Or reverse engineering? While this is always a hotly disputed and needlessly feared area of ISO 9001 requirements, it has a much wider application than most of us initially assume.  Here is the definition of design found in ISO 9000:2005:3.4.4: design and development is a set of processes (3.4.1) that transforms requirements (3.1.2) into specified characteristics (3.5.1) or into the specification (3.7.3) of a product (3.4.2), process (3.4.1) or system (3.2.1)

NOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development process.

NOTE 2 A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product design and development or process design and development).

There are a lot of nuances in there. Many different types of engineers are all involved in design (not only mechanical, electrical and software but also, by ISO’s definition, process engineers and system engineers).
Corrective action is when I fix a problem and the customer is happy, right?  While this may be the way most folks view it, actually there’s a lot more to it. In 2005, ISO added an additional word into their vocabulary list to help clarify it: “Correction” as opposed to “Corrective action.” In 2008, they added this clarification into the ISO 9001 standard. So, what’s the difference? A Correction is when you fix the thing that went wrong (the nonconformity) This is the immediate action to keep customers or management happy: rework the product, replace the thing that’s not working right with one that does, or edit the document requiring accurate information. A Corrective Action, then, is described in 8.5.2 of the ISO 9001 standard as something done to “prevent recurrence.” This is the thing you do to ensure the nonconformity never happens again. It also requires some strategic thinking. Therefore, it is crucial to always identify causes of nonconformities before defining and implementing a Corrective Action.
Saturday, 07 September 2013 16:43

How SMART are Your Quality Objectives?

S.M.A.R.T. Quality Objectives.

I recently watched Robert Alvarez provide an excellent description of Quality Objectives, and I share this concept with his permission.

ISO 9001:2008, 5.4.1 requires that management set measurable quality objectives. In over 13 years of auditing, I have seen many stated objectives—of which about only 20% are measurable and 10% are measured effectively.
What one thing in your QMS seems arduous but can help your company take a leap forward this year? For some, the answer would be finding ways to collect and analyze needed data. For others, it’s employee engagement in the company’s objectives. Or, resolving vendor relationships that remain painful despite effort.  For many, it’s finding new customers and new ways to serve old customers. What if I told you that all of these could be helped by the effective use of one tool?  In over 20 years of auditing, the one tool we’ve seen that has the greatest potential for change (but remains the most dreaded and least used) is Causal Analysis or Root Cause Analysis.  Most avoid it because it’s not fast and it can’t be done effectively by solely one person.
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