ASQ Recertification and In-house Training Requirements

Training, learning, conference, certification, recertification

Question

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?

Answer

You asked ASQ about standards for granting recertification 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 recertification 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

Operational Qualification (OQ) Challenges; Cpk vs. AQL

Q: We’re completing a validation of a plastic extrusion process, which has raised a few questions with me.

This validation exercise encompasses the installation qualification (IQ), operational qualification (OQ), and the performance qualification (PQ). The IQ is self explanatory, but the OQ is challenging. The process is dependent on the batch resin properties which vary enough that the extrusion processing parameters cannot be setup where good parts are always produced. One resin batch can use processing parameters that will not work with the next batch. A justification will be written and included in the documentation package to explain this. Does the inability of defining an operating window void or limit the validation?

My second question has to do with PQ acceptance criteria. The PQ will be three production runs using at least two different material resins (the largest source of variation). While production acceptance will be on an AQL=1.0, C=0 basis, these initial validation lots will be accepted on a process capability index (Cpk) level. While on the surface the acceptance difference may seem benign, it is causing some changes. The tolerance is such that the process routinely passes the Acceptable Quality Limit (AQL) test criteria but fails a Cpk requirement. Is it possible to accept PQ runs as they would be accepted in production?

A related question is the power of a Cpk vs. an AQL sampling plan. A Cpk value can be calculated using the same number of samples on a 100-foot run vs. a 10,000-foot run, while an AQL sampling plan is size dependant. Is there a criterion on sample size or a rule of thumb as to when one plan should be used over another?

A: First, the plastic extrusion process is always a tricky one to qualify simply because each new batch of resin always requires adjustments no matter how controlled the storage conditions are. So yes, you will have to define what adjustments your organization has to make and how big an operating window you need to transition from batch to batch.  If you can demonstrate that it can be resolved within a certain time (say, 15-30 minutes), then it should be ok for validation.  This is assuming that the customer is in agreement with what your company is doing.

Cpk formula, Cpk indexThe second question is a bit more difficult in that the Cpk is assuming that the process is in control and performing at a steady rate.  Cpk is a long term measure and requires the use of control charts to really control the process.  You may be able to work with your customer on help to get validated to the Cpk requirement, but you have to show the plan to get here.  In the past, some customers have been willing to provide an extended period to attain validation. You may want to talk to your customer representative to find out what help they can provide.

The third question gets to the fundamental heart of the situation: the question of using Cpk vs. AQL.  Cpk is a measure of process capability and AQL is a measure of long-term, outgoing quality.  Are they the same?  On some studies I did early on with Cpk and specifications, it was not always clear.  I have not seen any criterion on sample size on when to use Cpk vs. AQL.

Jim Bossert
SVP Process Design Manger, Process Optimization
Bank of America
ASQ Fellow, CQE, CQA, CMQ/OE, CSSBB, CMBB
Fort Worth, TX

For more on this topic, please visit ASQ’s website.

Six Sigma Standard

DMAIC process

Q: How are the new ISO 13053-1:2011 Quantitative methods in process improvement – Six Sigma – Part 1: DMAIC methodology, and ISO 13053-2:2011 Quantitative methods in process improvement – Six Sigma – Part 2: Tools and techniques standards to be used?

Is it for certifying Green and Black Belts, or what?  Are there plans for “registering companies” to the standard?  Thanks in advance for your response.

A: The scope of ISO 13053-1:2011 is to “recommend the preferred or best practice for each of the stages of the DMAIC methodology used during the execution of a Six Sigma project. It also recommends how Six Sigma projects should be managed and the roles of personnel involved in such projects. It is applicable to organizations using manufacturing processes as well as service and transactional processes.”

Similarly, the scope of ISO 13053-2:2011 is to “describe the tools and techniques to be used at each phase in the DMAIC approach illustrating them through fact sheets.”

There is no plan at this point to develop documents that have for intent, or scope, to certify Six Sigma Belts or to register companies to the standard.

Michele Boulanger
U.S. TAG to ISO/TC 69 Chair, SC7 Expert

For more on this topic, please visit ASQ’s website.

Delta Triangle

Manufacturing, inspection, exclusions

Question

When revising drawings to include the delta triangle in the title block, does the drawing index sheet also contain the triangle in the title block?

Answer

The term “delta” refers to a triangle placed on the drawing for reference. The triangle is commonly placed next to a dimension, such as 2.65, 5, or other locations where it applies to a feature or item. This is used to refer the reader to a general note that relates to this item.

So if the delta triangle is used as a reference in your main title block, then I would say yes, add it to the index sheet if it makes the reference more clear.

In addition to drawing a reader’s attention to notes, the delta triangle is also quite often used with print revisions. For example, if a drawing was a revision 2, and then a new revision is generated. It might say something simple like, Rev. 3- 2.235 dimension changed to 2.240. Then a delta triangle with the number 3 in it would be next to the 2.240 dimension referring to the revision.

Bud Salsbury
ASQ Senior Member, CQT, CQI

ISO 9001 Management Representative and Reporting Structure

Inspection, Management, Management Representative

Q: Please define the preferred method of meeting the requirements of the management representative in regards to clause 5.5.2.b in ISO 9001:2008 Quality management systems–Requirements.

My organization has reorganized, and I find the role of management representative somewhat detached. I work for a military organization that would like this role to be several layers below the base captain vs. the open door policy for the management representative used by previous commands. Should the management representative have direct access to the top?

A: There is no defined or preferred method for addressing the reporting arrangement for the management representative to top management. Your organization defines and deploys the approach that is workable for the management representative to report to top management.

Charlie Cianfrani
Consulting Engineer
Green Lane Quality Management Services
Green Lane, PA
ASQ Fellow; ASQ CQE, CRE, CQA, RABQSA Certified QMS-Auditor (Q3558)
ASQ Quality Press Author

For more on this topic, please visit ASQ’s website. 

ISO 9001 Clause 7.4.1, Supplier Control

Mr. Pareto Head and Supply Chain comic strip

Q: My interpretation of  ISO 9001:2008 Quality management systems–Requirements regarding supplier control as addressed in clause 7.4.1 Purchasing process is that suppliers who would require evaluation, selection and registry, would be those who supply products (or services) which affect subsequent product realization, or the final product.

Excellent examples for our organization would be vendors providing raw material, tool/dies, surface preparation or calibration services.

I also believe that the “extent of control” exercised by the organization, could, in fact, mean that certain suppliers are not controlled (evaluated, selected and registered), due to their lack of impact on product realization.

Good examples here would be stationery or sanitation supplies.

After conferring with several colleagues, we are all puzzled to see freight companies (UPS, FedEx) included as controlled suppliers and nonconformance reports written for failure to comply with the standard if they are not included on our approved suppliers list.

I understand the standard is written to provide a framework, and not examples, however I find this interpretation to be too broad for the intended purpose.

A: Thank you for contacting ASQ’s Ask the Experts program.  The intent of ISO 9001:2008, clause 7.4.1 is to ensure suppliers are selected based upon their ability to meet the organization’s requirements, which generally include quality and delivery of product or service intended for the customer.

As you mentioned, suppliers of office supplies such as paper, printer toner and etc. are not usually included on an approved suppliers list since they have zero impact on the organization’s ability to meet customer requirements.

However, some registrars may consider trucking firms or delivery services such as UPS and FedEx as suppliers of services that could impact an organization’s  ability to meet requirements, such as on time delivery and the delivery of product in an acceptable condition to the customer.

Most registrars welcome rebuttals from their clients regarding audit findings.  This could be an excellent opportunity for your company state its position to the registrar and to understand their rationale as to why they believe UPS and FedEx must be on the approved suppliers list.

The bottom line is that your registrar determines how its auditors interpret audit criteria such as clause 7.4.1.

If it is decided to add these companies to the approved supplier list, it should be a painless process since your company probably already has an established performance history for them.

I hope this helps!

Bill Aston
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
Kingwood, TX
www.astontechconsult.com

Design for Six Sigma

Control chart, data, analysis

Q: I am preparing a short training session for my company on the topic of Design for Six Sigma.  I am interested in looking at some examples of how other companies or organizations have used DFSS.  Is it possible to get case studies from ASQ on this topic?

A: Thank you for contacting ASQ and the Quality Information Center.  Design for Six Sigma (DFSS) can be defined as “robust design that is consistent with the applicable manufacturing processes to assure a fully capable process that will deliver quality products” (from The Quality Improvement Glossary by Donald L. Siebels).

For DFSS case studies, please visit ASQ’s website.

Z1.4 2008: AQL, Nonconformities, and Defects Explained

Pharmaceutical sampling

Q: My question is regarding the noncomformities per hundred units and percent nonconforming.  This topic is discussed in ANSI/ASQ Z1.4-2008 Sampling Procedures and Tables for Inspection by Attributes under sections 3.2 and 3.3 on page 2.  Regardless of the explanations provided, I find myself puzzled as to what the following numbers refer to in “Table II-A– Single sampling plans for normal inspection (Master table).”

Specifically, I am having problems understanding the following unit numbers just above the Acceptance and Rejection numbers (example, 0.010, 0.015, 0.025, 1000).  Do these represent percent noncomformities and if so,  does 0.010 = 0.01%, and conversely, how can 1000 = 1000%?

As you may see, I am very confused by these numbers, and I was hoping to have some light shed on this subject. Thank you for your answers in advance.

A: The numbers on the top of the table are just as the questioner stated: .0.010 = .01% defective.  That is the acceptable quality limit (AQL) number.  Generally, most companies want 1% or less, but as noted in the table, it does go up to 1000. It is extreme to think of something being more than 100%, but consider that it may be a minor or cosmetic defect that does not affect the function but just does not look good.  Scratch and dent sales are a common result of these higher numbers.

The AQL number is the worst quality level you would expect to find at this level.  The thing you have to remember is that these plans work best when the quality is very good or very bad.  If you are at the limit, you could end up taking more samples and spend a lot of time in tightened inspection.

Many people use percent nonconforming instead of percent defective, simply because of the connotation of “defective.” No one wants to say they shipped a defective product.  They may have shipped a nonconforming product that the customer could not use simply because their requirements were too strict, where another customer may be able to use the same thing because they have less stringent requirements.

Jim Bossert
SVP Process Design Manger, Process Optimization
Bank of America
ASQ Fellow, CQE, CQA, CMQ/OE, CSSBB, CMBB
Fort Worth, TX

For more on this topic, please visit ASQ’s website.

Does ISO 9001 Clause 7 Apply to Processes?

Manufacturing, inspection, exclusions

Q: Does clause 7 Product Realization in ISO 9001:2008 Quality management systems–Requirements apply to the design and development of manufacturing processes?

We have four facilities that are ISO 9001 certified under one certificate. One location designs the product, and the other facilities manufacture it. In the “design facility” we follow the requirements of clause 7. In the manufacturing facilities, we currently do not apply clause 7 for the process of developing the manufacturing processes.

A: ISO 9001 clause 7.3 is applicable to the design and development characteristics of a product.

ISO 9001:2008 clause 7.1 (Planning of Product Realization) and its reference to clause 4.1 (General Requirements) is more specific to product planning to ensure that the product quality objectives and the processes/resources are available to produce a product that will meet defined quality requirements as specified during design and development in clause 7.3.

Clause 7.1 requires that the planning process include identification of the inter-related processes (i.e., monitoring, inspection, product quality objectives, testing, records of conformity needed to verify the product requirements have been achieved.

The bottom line:  the product characteristics, quality objectives and inter-related processes must be documented.  If this is not fully achieved in the design and development process (clause 7.3), it must be included in the product planning process (clause 7.1). Please see clause 4.1.

Please keep in mind that your company’s ISO registrar will require evidence of conformity (records/documentation) to verify the requirements of clauses 4.1, 7.1 and 7.3 have been met.

Bill Aston
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
Kingwood, TX
www.astontechconsult.com

For more on this topic, please visit ASQ’s website.

Outsourcing and Quality

About ASQ's Ask the Standards Expert program and blog

Q: The company I work for has outsourced its manufacturing processes and will possibly be outsourcing some of its other processes (including its core quality operations) in the near future.  I am interested in ASQ articles that relate to the outsourcing of core company operations or how quality is affected overall by outsourcing.

A: Outsourcing can be defined as a “strategy to relieve an organization of processes and tasks in order to reduce cost, improve quality, reduce cycle times, reduce the need for specialized skill, and increase efficiency” (taken from The Quality Improvement Glossary by Donald L. Siebels).

For more on this topic, please visit ASQ’s website.