ASQ re-certification and in-house training requirements

Q: In our corporate audit department, we have a number of individuals that are ASQ certified.  What standards do we need to adhere to in order to provide in-house training that qualifies for ASQ re-certification units?

A: You asked ASQ about standards for granting re-certification units (RUs) from in-house training. There are two main concepts here:

  1. Training must cover some part of the affected certification body of knowledge or be taken for job enhancement.
  2. Every hour of contact time equals 0.1 RU.

Body of Knowledge (BoK). The training topics must cover some part of the certification BoK. This is pretty liberally interpreted. Each certification has a booklet, available for download from the ASQ web site, showing its BoK as an outline of topics. Make sure the training will support one or more of these topics.

Contact time. A one-day course is typically 6-7 contact hours, which would equate to 0.6-0.7 RUs. You cannot count lunch (unless it is a working lunch) or break times – just actual training.

Records. Most people receive a certificate of completion at the end of the training class. It shows name, date, course title, contact hours (or RUs), and person granting the certificate (need not be signed). The employee makes a copy of all these certificates and includes them in the re-certification journal/logbook. Pay particular attention that the date of the class is within the dates of the three-year ASQ certification.

Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net

ISO 17025 Certified Facility

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

Q: We have a specification that states test reports shall be from an facility certified to ISO 9001:2008 Quality management systems–Requirements. Our test reports are from a facility certified to ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories.

Isn’t ISO 17025:2005 under the ISO 9001:2008 umbrella?

A: Your interpretation is, indeed, correct. Actually, for a testing lab, accreditation to ISO/IEC 17025 is superior to registration to ISO 9001! As you know, your accreditation agency actually observed your personnel performing tests. They had to demonstrate competency. This was in addition to the verification that you had a working management system in place (that’s why they call it accreditation and not registration. We won’t even get into the misuse of the word certification).

To make sure your customer gets the assurance they want, I recommend you contact your accreditation agency. Ask them for a letter that states this equivalency. That will probably blow your customer away – or at least amaze them! Unless you can show the text you provided to ASQ was from one of the ISO or ANSI standards-writing committees, as an official interpretation, it probably holds little weight.

Your customer is right to monitor your performance this way. Recent food safety issues, prominent in the news, have a common element to them — insufficient attention to supplier performance. Expect to see more of this as the manufacturers and distributors pay more attention to their supply chain. I expect you are or will be doing the same for your critical sub-suppliers. Remember too, there are many ways to monitor supplier performance. Registration/accreditation is one of the ways.

Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net

Qualifications for QMS staff training position

Q: I work at an environmental testing laboratory company with facilities in California.  We are certified to ANSI/ISO/ASQ Q9001-2008: Quality management systems – Requirements ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories and are pursuing certification to  ANSI/ISO/ASQ E14001-2004: Environmental management systems – Requirements with guidance for use.

We are attempting to hire an assistant quality manager (AQM) whose primary function will be staff training on the quality management system.

We have identified an excellent candidate in Ireland and are attempting to secure a work visa for her in order to come to the United States and join us. The folks at the Immigration and Naturalization Service are demanding that we write a job description so that they can somehow justify bringing her into the country.  One of their requirements appears to be related to having a bachelor’s degree in education in order to fulfill the training function. In addition, they are demanding that we prove that this is an “industry standard,” namely, having an education degree in order to become a training manager.

My question for you is: is a bachelor’s degree in education a normal requirement for a quality training position? If so, can you offer any guidelines in terms of companies or types of firms that may have this requirement? If not, what can you tell me about normal background or education requirements necessary for the AQM – the training position that I am considering?

A: The short answer is no — a degree in education is not a normal industry requirement. I believe the Immigration folks are confusing this position with a school teacher who is required by most states to have a teaching certificate. One of the requirements for most teaching certificates is an education degree from an accredited college or university – the so-called “normal” schools.

An education degree is not normally required and usually not desired in industry.

It would be much better to emphasize the quality knowledge aspects. It is quite common for candidates to have one of the ASQ certifications, such as ASQ Certified Quality Improvement Associate certification (easier) or the ASQ Certified Quality Engineer certification (very hard).

Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net

ISO Documentation Practices; Difference Between Record and Document

 

ISO documentation practices, requirements

Q: Is there a published ISO standard for good documentation practices (e.g., crossing out an error with a single line and initialing and dating; striking through a blank space)?

Thank you.

A: Your question has two parts:

1) Is there a standard?

2) Does it cover the specific practice you cited?

The answers are “yes” and “no.”   🙂

About a decade ago, the ISO Technical Committee (TC) 176 on Quality Management and Quality Assurance started work on a documentation standard. There was (and still is) much confusion in the world about what kind of documents were expected and what should go into them. Of course, most didn’t want to take the time and energy to understand the purpose of documents, much less describe their practices in a site-specific manual. How sad. The output of the ISO/TC 176 work was a Technical Report: ISO/TR 10013:2001 – Guidelines for quality management system documentation. Frankly, however, I do not think it will address your question.

First of all, documents and records are often confused. Even though the ISO terms and definitions standard (ANSI/ISO/ASQ 9000:2005 Quality management systems — Fundamentals and vocabulary) parks them both under the word document, it is good practice to always think document=before, and record=after.

In other words, a document tells us what to do. A record tells us what was done. Many people, not understanding this principle, have actually tried to place records under configuration control!

The record-keeping practices you cited — crossing out an error and marking in a blank space — have their origin in the early military practices of the 1950s! Back then, there were no computers, internet or even ISO standards. There was also much more falsification of information back then, as we treated the workers with little or no respect.

The practices you cite were attempts to make sure that the data entered on a record wasn’t changed. Those practices just kind of hung on for half a century. In my 40 years in the quality profession, I have never seen these “rules” written down in an external document, like a regulation or standard or policy. Sure, individual organizations have required these practices through their local Standard Operating Procedures, but I am pretty sure they are not published in higher-level documents.

With automation and networking, records are becoming much more virtual. Paper records are becoming a thing of the past. Security and protection of those electronic records is a much bigger problem than when they were all on dead trees.

Follow-up from expert: Doing some further research (for an upcoming class), I discovered that ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories, contains a clause about records correction, 4.13.2.3. In general, the clause says all alterations must be visible (not erased, blacked out, or deleted), and all changes must be signed or initialed by the person making the change. Equivalent measures should be taken in the case of electronic records.

I don’t know why I didn’t think of this standard earlier, however, my earlier remarks about this coming from the 1950s practices B.C. (before computers) still stand.

Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net

ISO 9001 Quality Manual

ISO documentation practices, requirements

Q: My small company is forcing me in the direction of using flowcharts to specify ISO standards. With their many branch statements, they are convoluted and confusing. I prefer plain, simple English. But my question is: is it ok to use flowcharts to specify ISO 9001 standards?

A: Actually, as long as you do not intend to become registered (also called certified), you can – and probably should – implement the ISO 9001:2008 Quality management systems–Requirements standard any way you want! I happen to like flowcharts, as long as they are limited to one page and fewer than a dozen boxes.

But if you intend to become registered, the registrar you choose will always require you to explain how you are implementing the concepts contained in ISO 9001.  Most firms choose to call this explanation document a quality manual. You do not repeat the words in the ISO 9001, rather you say how you intend to implement the concepts locally. A manual should be site-specific and about 50-60 pages. Some have written them in 20 pages.

Once you have the framework (manual) in place for the system, then you need to write procedures for the processes. Remember, procedures are job performance aids for an already-trained and qualified person. They should be about five to six pages, since the individual already knows how to perform the tasks.

The powers that be in your company want these procedures to be in the form of flowcharts. That’s OK, as long as you have explained this in your manual. The registration company accepts your manual before they ever send an auditor to your site. If they have accepted your description of flowcharts instead of procedures, then the auditor must accept that approach.

The whole point is to provide information to the person doing the job in a way that is useful. Written standard operating procedures (SOPs), or flowcharts, or pictures. It is the implementation that matters.

Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net

Example Quality Manual

Need to write a quality manual that conforms to ISO 9001:2008? Download an example quality manual from the ASQ Knowledge Center and read about how to create one!

What’s the Difference Between ISO 9001 and ISO 19011?

Reporting, best practices, non-compliance reporting

Q: What is the difference between the ISO 9001:2008 and ISO 19011:2011 literature on your web site? Please provide a detailed explanation and their use.

A: I can see where the confusion might arise, as the numbers are very similar! But the contents are quite different.

ISO 9001 Quality management systems–Requirements is the mother of all quality management systems. It lays out the minimal requirements for an acceptable way of managing your business for quality. In the beginning, it was developed as a requirements document to lay on your suppliers. Then it became the foundation for registration (other countries might call this certification) of your own management approach to quality. About a decade ago, various business sectors – aerospace, automotive, medical devices, laboratories, etc., all used the ISO 9001 document as the base for their specific approaches. They didn’t take anything away, but added additional requirements. By far, the greatest use today is for registration/certification. This is somewhat sad, in that the standard itself is a beautiful way of managing the resources within the enterprise. Registration can get quite bureaucratic and not worth the expense.

ISO 19011:2011 Guidelines for the auditing management systems is the international auditing standard (my specialty). It was first developed as a means to get all the various registration agencies around the world to do their audits in a consistent manner. It also had support from the multinational companies that had factories – and thus registrations – all around the world and often with different cultures. Norms in Canada are not the same as China! Unfortunately, this registration emphasis in the standard made it somewhat hard for internal auditors and supplier auditors to use it. Plus, there is no requirement to use the standard, other than within the registration industry.

For these reasons, the U.S. wrote a supplement for the 2002 version of this standard, giving guidance on how to use the principles for internal audits and small organizations [note: development is underway to offer similar supplements for the ISO 19011:2011 version  — anticipated end of 2012/early 2013.]. ASQ is the only place to get this version, which  includes the supplement, along with the base document. As this auditing standard was revised, it picked up environmental auditing and safety auditing in the scope.

Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net