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

Z1.9 Sigma for varability known method

Q: I have a question about  Z1.9-2008: Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming. I have seen there is a “Variability Known” method. However I don’t know how to get a Sigma, so I don’t know how to use this method. Could you please share how to get a Sigma?

A: To get a Sigma to use for the Variability Known method is to have data that has been collected over a period of time and calculate the standard deviation. The rule here is at least six months of data with at least 50 data points.  Depending on the process, if the data has been collected and there is over 1000 data points, the time limitation goes away since you have an extremely large data set to work with.

Q: During the 6 months, the process should be under control, right? And data should be normal distribution, right? Is there any process control needed? And how do I maintain this process and Sigma?

A: Yes, there is the assumption that the process is normally distributed and is stable.  That means some type of process control is being used.  Ideally this would be an X-bar and r or an X-bar and S chart. If an out of control situation occurs and you can bring the process back into control, then you are ok.

Q: Could you tell me the meaning of “data point”? As you know, during the 6 months, we will get lots of batches. For each batch, we will have a certificate of analysis (COA), and many data. I am not sure how do you combine data for different batches. How do you calculate this?

A: Data point, in the most simple format, could be the statistics associated with a batch or a mean and standard deviation/range. Each batch gives you a new set of data points. You can combine the time based data in a couple of different ways:

1. You can take each batch and use the means and plot them on an X-bar and R or an X-bar and S-chart. 
2. You can take the raw data and combine it into one large distribution.
 
The preferred way is the control chart approach since you will know if the process is stable since it is already plotted.

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

AS9100 production rough card

Q: According to our customer requirement, our quality inspectors are signing each step in production rough card in the following way: they apply their personal stamp (which includes their first and last name and personal number), add add a manual signature and date. I tried to convince our customer to give us permission to eliminate the manual signature (as the personal stamp and date are enough), but he doesn’t agree with me.

Is there any official standard for this procedure? I was not able to find any special requirement for this in AS9100 Rev. C  – Requirements for Aviation, Space and Defense Organizations.

A: The AS9100 standard does not dictate any specific method of recording that a production step (clause 7.5.1) or verification step (clause 8.2.4) is complete. AS9100 does require the organization to comply with customer requirements. So this is a requirement which you need to discuss with your customer.

Buddy Cressionnie
International Aerospace Quality Group Americas AS9100 Lead
Voting member of the U.S. TAG to ISO/TC 176
Southlake, TX

Z1.4 or Z1.9 Sampling Plan for IT Tickets

Data review, data analysis, data migration

Q: I need to purchase a sampling standard. However I notice there are a few options for sampling plans, such as attributes vs. variables.  I am not sure which one will best fit my needs.  I need help in determining this.

I need to determine what the best sample size would be for recurring IT operations.  For example:  If my server team closes 500 tickets a month and I want to pick a sample size to review for quality purposes, what is the best chart to use to determine what the industry standards say are the recommended sample size?  My understanding is there is a light, normal and heavy chart that can be offered.

Please help.  Thanks!

A: The answer is “it depends.”  What it depends on what is she reviewing for quality purposes?  If the inspection is for either “good quality” or “poor quality,” then Z1.4-2008: Sampling Procedures and Tables for Inspection by Attributes, would be appropriate.  If she is measuring something, “time to close,” for example, then Z1.9-2008: Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming, might be appropriate, although Z1.9 is really only good if the data are normally distributed, which waiting times are generally not.

With more information, I could provide a more definitive answer.

Q: Our intention right now, is to evaluate tickets closed  (or work processed, which could be in other facets other than tickets, may be items logged in a log sheet to check service statuses, etc) to determine if the quality of work performed meets our quality standards.  We are determining what “quality” means to us.  For example:  We want to look at tickets closed to determine if the ticket was escalated properly from our tier 1 to tier 2 team AND if the work log of that ticket had the correct data and correct amount of data documented.  Meaning a tech didn’t just say “resolved user issue,” but rather they documented more relevant data about what they did to resolve the issue.  All of the work performed is service delivery in an operations environment, so the evaluations will be performed on the quality of following our processes and the quality of our resources.  We have an amount of tickets closed per month that vary, slightly up or slightly down.  I want to look at a table to determine what our sample size should be.

However, in addition to the above, I am very interested in learning the other plan too because we do have Service Level Objectives (SLO’s and SLA’s) in this environment (example: time to close, first call resolution, call abandonment rate, etc) If I can understand that other table and how to use it, both may be valuable and I may purchase both.

I didn’t understand the comment that “Z1.9 is really only good if the data are normally distributed, which waiting times are generally not.”  What does normally distributed mean?  I would like that explained.
Can your expert answer and provide information on both sampling plans for me?

Thanks again and I look forward to the response.

A: Normally distributed means that the data follow a bell-shaped curve with the most frequency values falling around some average and tailing off in frequency both above and below that average.  Many processes in real life follow the normal distribution.  Time to close is an exception.  It is more likely to follow the exponential distribution, which means that there will be lots of tickets closed at shorter durations, with some tailing out very far into longer durations.  Also a ticket can’t be closed at less than 0 duration.  The normal distribution extends, in theory, to +/- infinity.  Rates (percentages, I’m assuming) can often be approximated using the normal distribution as long as they aren’t too near 0% or 100%.  If they are near the edges a square root transformation often help to make the data more approximately normal.

Most of the quality characteristics you described are of the pass-fail variety which implies Z1.4 would be appropriate.

I strongly recommend that you take a course and/or read a book on statistical process control or acceptance sampling before attempting this.  There are many potential gotchas that can lead to erroneous analysis and therefore decision making.  ASQ offers some that are quite good.  A comprehensive book would be:

Process Quality Control: Troubleshooting and Interpretation of Data, Fourth Edition
by Ellis R. Ott, Edward G. Schilling, and Dean V. Neubauer.

Brenda Bishop
US Liaison to TC 69/WG3
CQE,CQA,CMQ/OE,CRE,SSBB,CQIA
Belleville, Illinois

Framework to Integrate ISO Standards and Non-ISO Standards

Reviewing confidential files, training records, human resources files

Q: I have a few questions about integrating standards for one of the experts:

1) Will registrars (in addition to BSI, who wrote it) accept a documented quality management system organized around the framework suggested in PAS 99:2006 – Specification of common management system requirements as a framework for integration, given there is adequate audit evidence that the requirements of both of the integrated standards have been addressed and have been implemented?

2) Is PAS 99 only for ISO-related standards, e.g.,  ISO 9001:2008 Quality management systems–Requirements and  ISO 14001-2004: Environmental management systems – Requirements with guidance for use, or can other combinations be made – e.g., ISO 9001 and American Institute of Steel Construction-Bridge and Highway AISCQC028?

AISCQC028 is not an ISO or ISO sector-specific standard, although the framework and structure is very similar. The AISC has its own certification body (registrar) and would insist that their auditors conduct a certification audit even though an organization has been previously ISO registered. AISC does not object to an integrated system that integrates/combines ISO 9001 with one of their certification standards as long as AISC certification requirements have been addressed.

The integration of ISO 9001 and 14001 is becoming common place and I’m fairly certain that PAS 99 is an acceptable format in those cases. I’m more interested in other industry standards and requirements not generally considered ISO-related that are being demanded by certain customer segments and integrating them in a system that must also be acceptable to ISO registrars because of other customer segments who are demanding ISO registration by their suppliers.

A: This is an excellent, and timely, question.

More and more organizations are developing integrated management systems based on multiple specification standards – such as ISO 9001, ISO 14001 and OHSAS 18001.   In addition, there are more and more management system standards being developed.  This includes both ISO standards and non-ISO standards – such as OHSAS 18001, Responsible Recycling (R2) and, based on your question, AISCQC028.

It is not even clear how many different management system specification standards there are. What one individual considers a guidance document; someone else insists is a specification standard suitable for certification.

So when you are developing documentation for an integrated management system, how should it be organized?

There are several options:

•    One option is to choose one of the standards as the primary high-level structure – say, ISO 9001:2008 – and address the requirements of the other standards within that structure.

•    PAS 99:2006 offers a different option for a high-level framework for organizing the management system documentation for an integrated management system.  (As you correctly point out in your question, PAS 99 cannot be used as a replacement specification standard for any of the discipline-specific management system standards.)

•    Another option is to establish a high-level structure that makes sense for your organization.

There is no required framework for organizing management system documentation.  You can use whichever overall structure and numbering scheme works for your organization.

ISO has recognized that having different high-level structures for its various management system standards may be problematic for organizations that are implementing integrated management systems that are intended to meet the requirements of multiple specification standards.  As a result, in February 2012, the ISO Technical Management Board (TMB) approved a guide for ISO standard writers that specifies a common structure and definitions to be used for all new and future revisions of ISO management system standards.  This was circulated as ISO Guide 83. This action by ISO highlights the primary issue with using PAS 99:2006.  It is out-of-date.

First, the normative references listed in PAS 99:2006 are not the current versions for some of the standards (notably ISO 9001 and OHSAS 18001).  Second, the high-level structure set out in PAS 99:2006 is not consistent with the common structure recently approved by ISO.

The key to establishing an integrated management is NOT the use of a particular organizing framework or high-level structure.  How you organize your management system documentation needs to fit the needs of your organization – not the desires of a particular registration auditor.

What is important is being able to clearly explain how your management system meets the requirements of each of the specification standards to which you want to become certified.  This requires clearly written documentation that defines the links to the requirements you are addressing within your management system.  It may also require discussion with your registrar and/or the use of reference tables – similar to those set out in the Annexes of ISO 9001, ISO 14001, OHSAS 18001 – and PAS 99:2006.

Thea Dunmire, JD, CIH, CSP
ENLAR Compliance Services, Inc.
Thea’s Blogs:
www.OHSAS18001expert.com
www.managementsystemexpert.com

ISO 9001 7.1 Product Realization

Suppliers, supplier management

Q: Our company, certified to ISO 9001:2008 Quality management systems–Requirements, is experiencing quite a bit of supplier non-conformance.

An option we are interested in is to have a set of manufacturing drawings for our suppliers and a set of inspection drawings. Either the manufacturing set would require tighter tolerance than the inspection set, or the inspection set would have looser tolerances than the manufacturing set.

What would the criteria be to introduce this theory into our procedures?

A: I suggest that you consider the point of ISO 9001:2008 Quality management systems–Requirements, clause 7.1, regarding the development of product objectives. Your planned approach is similar to what is intended by this clause.

The organization should set its product requirements during the product planning stage. Product requirements should be based upon design inputs, outputs, verifications and validations. This provides the essential measurements (tolerances) required for the product to function as designed or intended.

The requirements sent to suppliers, or to the shop floor, should be within the design tolerances or criteria, but not necessarily the same. However, in the event that inspection or a supplier identifies/provides a product that is outside the drawing requirements, it would be up to the engineer or the designer to decide if the product still meets the design criteria. If so, the product would be disposition “accept as is” and would still function as planned.

If repetitious non-conformance is encountered and the product is still within the design criteria, then changes to the supplier and inspection criteria should be considered to prevent continued non-conformance. If the non-conformance does not meet the product requirement or the design criteria, corrective action should be taken with the supplier.

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

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

Random sampling

Q: When inspecting components on tape and reel, pulling parts at random can present a problem in a pick and place operation.  Also once removed, the samples would have to be put back on tape for use.

Is there a practical or common sense procedure to follow?

A: This is not an uncommon problem and I know that I’ve been in a similar situation. What we did was to inspect at the beginning and the end of each tape. That way we were not causing disruption to the process.  It worked pretty well with the suppliers we had. But prior to doing that, we certified our suppliers by going to their facility and performing a process audit to make sure that the process was meeting our requirements.

Jim Bossert
ASQ Fellow

Coordinate Measuring Machines (CMMs) and Digital Bore Gages

Gage R&R, Torque Wrence

Q: When inspecting diameters with tolerances of .0005 and below, are there any studies relating to the accuracy of different inspection methods, such as a coordinate measuring machine (CMM) versus a digital bore gage with setting ring combination?

A: The answer to this question can often be one of opinion and/or personal preference.  What I will present are my opinions, along with some known facts.

Non-contact measurement systems such as optical and laser equipment are bulky, expensive and impractical.  With these systems, the part must be taken to the system. This is not much good in a production environment.

While a CMM is without a doubt very accurate, they are also slow.  Like the optical or laser equipment, the parts must be taken to the system.  In many production situations it is more practical to check the part in the machine.  Also, even though CMMs come with reticulated heads, measuring at abstract angles or various depths is not always an option.  It is also wise to keep in mind that deeper bores would require longer stylus probes.  This is a situation that can introduce concerns of error and rapid movement can generate false contact readings with longer styli simply due to the motion.

A final thing to keep in mind is the high initial price of a CMM, as well as the maintenance costs.

Two and three point contact measurement is readily available.  Popular digital bore gages are calibrated to a master ring.  The rings themselves can be verified with a CMM or sent out for certification traceable to national standards. Most digital bore gages can be set up to interface with a statistical process control system. This is important when process control is vital.

Cylinder bore gages (generally two point contact) can sometimes have problems with linear accuracy. Analog versions can be more prone to operator error.

While two point systems will more readily detect ovality, where this is not a major concern, three point digital systems are, in this quality technician’s opinion, the best all-around option.

When I am inspecting parts in which ovality could be an issue, if the parts are readily portable, I will check a percentage with a CMM to verify their roundness.  However, for speed, accuracy, practicality, and price, a three point digital bore gage would be the way I would go to verify product with tight tolerances.

A final note: If parts are relatively small and can be in contact with other materials, robotics is often used with air gage instruments.  This is another expense but can be introduced in high volume manufacturing.

I hope this will help.

Bud Salsbury
ASQ Senior Member, CQT,CQI

Standard Vs. Specification and Guidance Documents

Standards, specifications, guidance, and research

Q: What is the difference between a standard and a specification?

A: There is no single or simple answer to your question. The answer depends upon the context of the question. Relative to the ANSI/ISO/ASQ Q9000 Series: Quality management standards, I direct you to ANSI/ISO/ASQ Q9000:2005 Quality management systems – Fundamentals and vocabulary.

ISO 9000:2005 defines specification as a document that states requirements. A specification can be related to activities (e.g. procedure document, process specification and test specification), or products (e.g. product specification, performance specification and drawing).

ISO 9000:2005 does not define “standard”. The first part of the ISO 9000:2005 introduction reads:

“The ISO 9000 family of standards listed below has been developed to assist organizations, of all types and sizes, to implement and operate effective quality management systems.

ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality management systems.

ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that fulfill customer and applicable regulatory requirements and aims to enhance customer satisfaction.

ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management system. The aim of this standard is improvement of the performance of the organization and satisfaction of customers and other interested parties.

ISO 19011 provides guidance on auditing quality and environmental management systems.

Together they form a coherent set of quality management system standards facilitating mutual understanding in national and international trade.”

In other words…

ISO 9000 is a standard that describes fundamentals and specifies the terminology.

ISO 9001 is a standard that specifies requirements.

ISO 9004 is a standard that provides guidelines.

ISO 19011 is a standard that provides guidance.

This implies that a standard is a formal document that establishes uniform criteria, methods, processes and practices — which may or may not be requirements.

ISO 9000:2005 also makes a distinction between quality management system requirements and requirements for products using the terms “specifications” and “standards.” It states:

“The ISO 9000 family distinguishes between requirements for quality management systems and requirements for products.

Requirements for quality management systems are specified in ISO 9001. Requirements for quality management systems are generic and applicable to organizations in any industry or economic sector regardless of the offered product category. ISO 9001 itself does not establish requirements for products.

Requirements for products can be specified by customers or by the organization in anticipation of customer requirements, or by regulation. The requirements for products and in some cases associated processes can be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory requirements.”

Joe Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 (AAMI)