Corrective actions

Craig Cochran from qualitydigest.com gives us this good article
When I first got into quality, I really hated verifying the effectiveness of actions taken to correct a problem. After all, I was young and inexperienced. All of the people whose actions I was verifying were older, wiser, and more experienced than I was. Who was I to say that their actions were effective or ineffective? My assumptions were as follows:

• If they said they did something, then they certainly did it.
• Whatever they did was directly related to the problem causes, or they wouldn’t have done it.
• The action must have been effective; they would have told me otherwise.

All of these assumptions had to be correct, because I was working with seasoned professionals, right? Ha! Boy, did I learn a lesson.

People just want to get paperwork off their desks or out of their in-boxes as quickly as possible. Taking actions on problems is one of many responsibilities that people have and, unfortunately, it’s not always top priority. That’s why it’s crucial that action be carefully verified. Verification is not an act of suspicion or disrespect; it’s simply a necessary part of problem solving.



What exactly is being verified? You are seeking evidence that the causes of the problem have been removed or reduced. In a perfect world, each problem cause would be removed. Poof, it’s gone. This is not always possible, though. Sometimes the best you can hope for is a reduction of the causes. The cause is still there, but it manifests itself less frequently or less severely. So the best option is to remove the cause, but the next best option is to at least reduce the cause.

read full text on qualitydigest.com

The new standard makes it clear that an outsourced process is
still part of your QMS even though it is performed by a party that
is external to your organization. The new standard emphasizes
the need to ensure that outsourced processes comply with all
customer and legal requirements. While the responsibility for
a process may have been outsourced, your organization is,
nevertheless, still responsible for ensuring that it meets all
customer, regulatory, and statutory requirements.
….

Documentation
ISO 9001 2008, Part 4.2.1, makes it clear that QMS documentation
includes not only the records required by the standard but also the
records that your organization needs to have in order to be able to
plan, operate, and control its QMS processes. So the new standard
has expanded the definition of documentation to include all QMS
process records.



Part 4.2.1 makes it clear that a single document may contain several
procedures or several documents may be used to describe a single
procedure. While this has always been an option, the new standard
makes this possibility explicit.

read full text on praxiom.com

Quality Control

Two small software vendors this week released business intelligence product upgrades that will allow manufacturers to more accurately and rapidly assess the cost and quality of their products.

SigmaQuest Inc., a provider of on-demand product quality analysis tools, released version 6.1 of its flagship SigmaSure product, which adds several new features, including support for identifying potentially costly, low-quality “maverick” products before they are shipped.



At the same time, aPriori, a provider of cost management analysis software, delivered version 5.5 of its self-named tool, which, among other things, allows manufacturers to compute the cost of a single component manufactured in multiple internal or supplier plants.

The most significant new feature in the 6.1 release of SigmaQuest’s SigmaSure is support for analysis of maverick parts and products, a capability that is increasingly important to manufacturers of electronics components, SigmaQuest’s largest customer base. A maverick part is defined by the JEDEC Solid State Technology Association as an “atypical product that exhibits anomalistic characteristics causing higher-than-normal levels of failure in the end-user application.”



Maverick parts, for example, may fall within prescribed functional test parameters but still fail often in the field, leading to costly product returns. Many electronic equipment OEMs, said SigmaQuest CEO Nader Fathi, have begun to require component suppliers to certify that they have analyzed part lots for their potential to exhibit maverick behavior.

“Just looking at product yields is not good enough to determine if products will behave correctly,” Fathi told Managing Automation today.

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1. Certification to ISO 9001:2008 will only be issued after publication of ISO 9001:2008 and after a routine surveillance audit or re-certification audit against ISO 9001:2008.
2. One year after publication of ISO 9001:2008, all certifications issued (new certifications and re-certifications) must be to ISO 9001:2008.
3. Two years after publication of ISO 9001:2008, existing ISO 9001:2000 certifications will not be valid.

This transition plan is possible because ISO and IAF have agreed that ISO 9001:2008 introduces no new requirements. The revised quality standard only introduces clarifications to the existing requirements with minor revisions to improve consistency with ISO 14001:2004, the environmental standard.



The revisions to ISO 9001:2000 are described below – deleted text is indicated by strikethroughs – new text is underlined and shown in standard font – text from the standard is shown in italic font to distinguish them from our comments. Most of the text in ISO 9001:2000 has not been affected by ISO 9001:2008.

0.1 General

In this section of the Introduction, ISO 9001:2008 adds “business environment” to the list of factors that influence the design and implementation of a quality management system.

The design and implementation of an organization’s quality management system is influenced by

• its business environment, changes in that environment, or risks associated with that environment,
• its varying needs,
• its particular objectives,
• the products it provides provided, – the processes it employs employed, and
• its the size and organizational structure of the organization.

ISO 9001:2008 changes “regulatory” to “statutory and regulatory” and clarifies that the Customer, statutory and regulatory requirements are those applicable to the product.

This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory, and regulatory requirements applicable to the product, and the organization’s own requirements.

0.2 Process Approach

ISO 9001:2008 focuses on “determine” linked activities rather than “identify” linked activities to clarify that a Process can be an activity or set of activities.

For an organization to function effectively, it has to identify determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.



The definition of Process Approach has been clarified by adding text:

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach“.

Read more here http://www.quality-control-plan.com/changes-to-iso-9001-2000.htm

In truth, ISO 9001:2008 is only slightly changed from the 2000 edition. It was reviewed just as all standards are – to ensure that they stay relevant and useful.

In the case of ISO 9001, which now has a million certifications in 170 countries, the review process is especially rigorous. Around 1,000 organizations participated in an extensive user-feedback survey and the results were extensively analysed. This exercise demonstrated that, in the words of Charles Corrie, secretary of the ISO drafting committee responsible for the ISO 9000 series, “Internationally, the companies using this standard are comfortable with where the standard is at the moment.” Hence the small amendments.

“We want to constantly monitor the standard to ensure that it’s still giving leading-edge advice to organizations to help them be competitive,” says Corrie. “We don’t want an outdated standard that is no longer helpful to the marketplace.”

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