Ask the Standards Experts

ISO 9001 Implementation

Audit, audit by exception

Question:

As Quality Manager I have been assigned the task of getting the company ISO Certified. Certification was granted in 2000, but their old system is in bad condition. The structure is incomplete, the organization and wording were created by an accountant and a shop foreman with little formal education. And it shows.

I have a copy of ISO 9001:2008, and attempting to integrate the old into the new is disheartening. Restructuring the system is the only answer, and so my question is:
Should all (8) sections, and all associated sub-sections of the ISO standard be the same in my standard?

I’m speaking in terms of the section and sub-section naming, and organization. The details of each I will define in accordance to our specific applications, but for ease of auditing am I on the right track?
Thank you for your time in this matter.

Response:

Thanks for contacting ASQ’s Ask the Experts program. Based upon the information provided, I would suggest that you consider developing your new quality manual using the same or similar layout of sections and clauses found in ISO 9001:2008. Although it is up to every company to select a format, or structure, for their QMS that will best support their own needs, using a format that is consistent with the layout of ISO 9001:2008 will help facilitate future audit activities.

Since your company was previously certified as mentioned in your inquiry, most of the work with regard to section and clause references should have already been completed. Likewise, it should be noted that the structure, or format, of ISO 9001:2000 vs. ISO 9001:2008 is essentially identical. So, all section and clause references should already exist in your current quality manual.

To ensure that your objective of obtaining ISO 9001 recertification is accomplished in a timely and cost effective manner, I recommend that your company consider the following steps:

Identify the timeline for completing the development, implementation and recertification of your QMS.
Contact a Registrar to determine their costs, requirements and availability to meet your timeline for QMS recertification.
Assess the availability of internal resources (personnel) that will be required for the development, implementation and maintenance of the QMS.
Identify your company’s need to obtain external support from a qualified QMS consultant to assist with the recertification of your QMS.

Before beginning your QMS recertification project, it is highly recommended that your company first conduct a gap analysis of the present quality management system and all related processes. This will greatly help to identify what actually needs to be done to meet ISO 9001 certification requirements. This information can be used to establish a realistic project timeline, and estimate required man-hours and associated costs for recertification.

Please review ASQ’s Ask the Experts, Blog for other related posts such as “The Cost of ISO 9001 Implementation”. I hope this helps.

Best regards,

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
Kingwood, Texas
www.astontechconsult.com

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

Best Practices for Non-Compliance Reporting in ISO 9001

Reporting, best practices, non-compliance reporting

Question:
I have just assumed the role of Quality Assurance Manager for a worldwide manufacturer and installer of transportation systems. As part of learning my new responsibilities and getting familiar the existing Quality Management System (we are currently ISO 9001:2008 certified), I have encountered some things that I think may need to be changed. Any opinions and/or advice would be greatly appreciated.

Here’s the issue; our current system for generating and tracking Non-Compliance Reports (NCRs) seems flawed. The way it is set up, all NCRs that are generated include a check box to show any Corrective Actions or Preventative Actions. If these boxes should be checked, the report is now called a NCR/CAR/PAR, all on the same form. The creator can then enter any actions taken. There is also a section to enter the “solution” for the non-compliance. The way this system works, it is not possible to create just a Corrective Action or Preventative Action Report (CAPA); they are shown as results, or solutions, to the NCR. Is this a good practice?

Are there better ways to utilize this process? In going through the report from last year’s third party ISO audit, it was mentioned that we needed to improve on this process, and that the NCR/CAR/PAR should be tracked separately. Any suggestions?

Response:
Generally, it is a good idea to use the same process for internal corrective action, a supplier corrective action, or a preventative action activity. This will ensure that all required steps will be followed. As a Senior Quality Director for a company, we had our computer system log each type separately as we set different deadlines for our corrective actions and preventatives.

The issue may be resolved by having the reporting system separate each type with aging timeless. I believe each type needs to be tracked and reported monthly as well at Management Review meetings.

Ron Berglund
ASQ Fellow

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

Method of Using Gauge Pins

Question:

We recently received a complaint from a customer who claims a diameter hole is oversize. The method of gauging the diameter is with minus gauge pins. The part is a plastic molded part (the material used is PBT). The diameter is .150 +.004 /-.002.

The method question is we do not force the maximum pin in the part, we use the weight of the pin to fall into the opening using no hand force pressure except to guide the pin over the opening.

Our customer is using a method of hand pressure to force the maximum pin in the diameter opening. If the gauge pin begins to enter they continue to try and force the pin and record the hole as oversize.

Are there any instructions on the proper method for using gauge pins in regards to hand pressure, force entry, and gauge pin weight?

Thank you.

Response:

This is a question that comes up often. To begin with, let me say that a gauge pin should never be forced into a machined hole. The largest pin that can be fully inserted and extracted using only light finger grip on the sides of the gauge is what will determine the hole size.

Most gauge pins used in industry today are Class Z. These can be either “Plus” or “Minus” pins. Those most commonly used are the Minus pins. They are tolerance up to -.0002”. Therefore a .9998 gauge pin might be actual size but it is generally referred to as a 1.000” pin (The size shown on the pin).

It is common practice in American industry to use a GO/NOGO pin set up. The size you mentioned, .150 +.004/-.002 would require a GO pin of .152 and a NOGO pin of .154. If NOGO pin will not fit but, the Go pin can be fully inserted without interference, the part is acceptable on the low end of the tolerance. If the NOGO pin fits without interference, then the hole is oversize and the part should be rejected. To touch on that just a little further, keep in mind, if you have a 1.000 hole, a 1.000 pin cannot be inserted into it. That would be a size-on-size interference fit. However, a 1.000 Minus pin might slip in without difficulty. Pages from gage-inspection-mil-std-120

One other thing to keep in mind is the surface finish of the holes. A hole that is out-of round could also introduce fit problems.

The Machinery’s Handbook shows the American National Standard Tolerances for Plain Cylindrical Gauges. However, there really is no documented standard (that I am aware of) which tells you how tight or how loose a gauge pin should fit. The common practices noted above should help you there.

You mentioned that “if the gauge pin begins to enter they continue to try and force the pin”. It is not uncommon for the beginning of a machined hole, or a hole in an injection molded product to be slightly larger near the surface. Various machining and/or molding practices would eliminate that. Yet, it is the ‘full’ insertion and extraction of a pin, without forcing, that determine acceptance criteria.

Thank you for the good question.

Bud Salsbury, CQT, CQI

ISO 9001 Cost of Implementation

Question:

What are the estimated costs of implementing ISO 9001?

We are a company of five divisions, Contract Manufacturing, Structural Fabrication (AISC & ASME cert), Steel Service Ctr, Rebar (CRSI vert) & Metal Castings. We employ approximately 200 people and operate out of two facilities. Our Metal Casting division is a separate location from our other operations. I am trying to generate an ROI and a time frame of implementation.

Answer:

The effect of ISO 9000 certification on financial perfomance

Thank you for contacting ASQ’s Ask the Experts program. This is an excellent question and one that is often asked by companies that are considering ISO 9001:2008 certification. In order to accurately estimate those costs that will be associated with obtaining ISO 9001 certification, the following approach should be considered:

The first step should include contacting a Registrar to identify the following:

Cost of application fee.
Cost associated with conducting required stage 1 and stage 2 audits for ISO 9001 certification.
Hourly and per day rates charged for offsite and onsite audit activities.
Administrative fees, if any.
Travel time costs (minimum and maximum daily charges).
Other associated costs for airfare, hotel, meals and car rental.
Frequency and cost for surveillance audits to maintain certification.
Cost for quality management system re-certification.

Discuss your company’s plans and timeline with the Registrar to obtain QMS certifications at separate locations. There may be an opportunity to share or save costs. As an example, consider establishing a single corporate quality manual and QMS procedures that will be common to both facilities. Also discuss the availability and location of potential Auditors that the Registrar may assign to your facilities, usually the closer they are, the better.

In addition to determining the Registrar’s costs, it is equally important to determine the Registrar’s certification requirements. Some require that at least four (4) months of records be available to provide evidence of conformance and implementation of the QMS. Consider contacting a couple of Registrars, and compare their costs and requirements. Another important point is to select a Registrar that is familiar with your industry or business sector. Be picky and ensure that the Registrar can assign an Auditor that has past experience that relates to your QMS processes or product line.

Step number two is to determine the availability of in-house expertise that will be required to develop and implement a quality management system for certification. If these activities are going to be outsourced, contact an experienced QMS consultant and request that a quote for a gap analysis be provided. Do your homework before selecting a QMS Consultant! Contact a few QMS Consultants, compare their rates and request contact information for past clients, or other references, to verify their experience and reliability. Again, select a Consultant who has past experience with your industry, processes and/or product line.

Confirm that the results of the gap analysis will document all areas that meet certification requirements as well as those that do not, preferably by clause number. The results of this gap analysis will be used by the Consultant to estimate the number of the man-hours that will be required to develop and assist with the implementation of the QMS for certification.

The bottom line is that the cost to obtain ISO 9001 QMS certification cannot be effectively estimated without knowing these four (4) items:

The Registrar’s cost for ISO 9001 registration.
The company’s current level of conformance with ISO 9001 requirements.
The amount of resources that the company will dedicate to this project for development and implementation.
The amount of support that will be required from a Consultant and the associated costs.

The following link to a flow chart provides a general overview of the ISO 9001:2008 QMS certification process.

ISO9001.2008.Cert.Process

I hope this helps.

Best regards,

Bill Aston, Managing Director
Aston Technical Consulting Services,
Kingwood, TX
Website: http://www.astontechconsult.com
email: quality@astontechconsult.com

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

ISO 9001 Management Checklist

About ASQ's Ask the Standards Expert program and blog

Question:

Is there a list of duties for implementing ISO 9001:2008 for the management representative? I am interested in a checklist of responsibilities for that individual to use as a guide to help a company prepare for an ISO 9001:08 external audit leading to certification.

Response:

Thank you for your question.

In answer to your question, I must mention section 5.5.2 of the ISO 9001:2008 Standard. Here is the first place you will see a list of duties and responsibilities for the Management Representative (MR). While the points noted in 5.5.2 a, b, and c cover a lot of areas, I think you are looking for an expanded list and one with more specifics.

One important beginning step is a Gap Analysis. This will help your organization and your MR to see where you are at and where you need to go. From the results of your Gap Analysis, your MR and the Planning Team (if you have one) can generate a Gantt Chart. This will be a good guide to help everyone involved recognize where your company is during the implementation process.

The management representative (MR) has the responsibility of getting the quality management system (QMS) put in place. He/she must also keep the QMS effective and up to date. Your MR must report the current status of your QMS to top management.

The MR must also be well aware of management concerns and be capable of representing the company. I remember reading somewhere that a good MR is;

A member of management (not necessarily a QC Manager).
Willing to learn.
Willing to teach.

All three of these items require capability. Capability to manage, learn, and teach.

As a final point on this question; I would advise that you acquire a book or more than one which can be used as a guide. ASQ has numerous publications which would help you to generate a list of your MR’s duties. The list can be long or short, depending on your company. It is always necessary for a management representative to be good at communicating, learning, researching, training, standing firm when necessary, and recognizing the importance of team work.

Bud Salsbury, CQT, CQI

Some additional resources available through ASQ:

ISO 9001:2008 Explained and Expanded
Optimizing your QMS Success
Charles A. Cianfrani and John E. “Jack” West
Print Book: http://asq.org/quality-press/display-item/?item=H1446

A Practical Field Guide for ISO 9001:2008
Erik Valdemar Myhrberg
Print Book: http://asq.org/quality-press/display-item/?item=H1369

ISO Lesson Guide 2008
Pocket Guide to ISO 9001:2008, Third Edition
J.P. Russell and Dennis Arter
Print Book: http://asq.org/quality-press/display-item/?item=H1344

ASQ Gantt Chart: http://asq.org/learn-about-quality/project-planning-tools/overview/gantt-chart.html

Z1.4: 2008 Sampling

Sterile, Lab, Clean Room, Requirements, Standard

Question:

We are having an interpretation issue regarding the ANSI/ASQ Z1.4:2008 standard with some of our component vendors. We have a number of different defects that fall into an AQL of 1.0.

Please note that the same question applies to all AQL levels, as our critical and minor defects can also have multiple defects.

Our interpretation of the standard is that if the sampling plan table (based on sample size and inspection level) shows Accept 7 / Reject 8 then all defects in this major category would be cumulative for the accept / reject criteria. (i.e. 3 that fail outer diameter, 3 that fail height of the bottle finish and 3 that fail weight – total of 9 – would constitute a rejection of the lot). The vendor’s interpretation is that each of the items within the major category should have an accept / reject allowance of 7 / 8 (so potentially, in this case, 56 defects would still be accepted).

Response:

In this case, it depends on the question the lot sampling is trying to answer. If they want to know if individual units within the lot are acceptable – based on all criteria that is considered acceptable, then the tally of all defects found is correct. This is further supported by any item with one of the many specifications out of range would be deemed a failure.

On the other hand, if the lot sampling is to detect lots with specific faults, isolated to a specific specification then the defect types would be considered separately. If the AQL 1.0 is suitable for the specific defects, then considering them separate for the 8 criteria would no longer be an overall ASQ 1.0 protection; it would be much less.

Your example of 56 defects being accepted underscores the point that the AQL protection is no longer 1.0.

I’m assuming the specifications and causes of the defects are independent, yet that may not be the case. When not independent I’m not sure how to adjust the sample size to a present the same AQL protection. When independent you would need separate draws of samples for each defect of interest, then apply the Accept 7/Reject 8 criteria judging only the one specification.

In practice, if you want to inspect for isolated specifications, one should allocate the acceptable AQL and LPTD points and develop your sampling plan from there. Instead of a 1.0% defect rate for AQL it would need to less for one of the Reject 8 specifications; try 0.125 so that the tally of failure rates across the various specification of interest (assuming the possibility of failing any specifications is equal). This will lead to much larger sample sizes that may be useful when troubleshooting specific faults.

Cheers,
Fred

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ISO 9001 Quality Policy

Audit, audit by exception

Question:

ISO 9001:2008 clause 5.3 regarding quality policy requires that it should include commitment to continually improve the effectiveness of quality management system. Our Registrar is saying that for compliance these same words should be included in the quality policy. Our opinion is that our policy includes commitment to continually improve the standard of services to that client which in real terms is how the effectiveness of QMS would be measured. We feel that copying words from the standard will not add any value. Any suggestions on how we should respond to the Registrar.

Response:

Good Morning,

I read your question and can understand why you might be somewhat confused. Please notice that the words in the standard say that you are to “continually improve the effectiveness of the quality management system.” I’m sure that your quality management system (QMS) covers all parts of your organization, not just your ‘standard of service.’ The intent of the standard is not to insist that your quality policy is copied word-for-word from the standard itself. Nonetheless, the word “shall” at the beginning of 5.3 indicates a requirement. You are required to include those main points in your policy, which will help your entire organization remain compliant.

Consider this-it is common practice that companies generate their Corporate Quality Policy first. Everything after that, the procedures, the work instructions, etc. fall in line under the main points delivered in that policy (5.3c “provides a framework for establishing and reviewing quality objectives”). If your organization’s quality policy only suggests improving your ‘standard of service’, then is the rest of your QMS to be left on its own as “good enough”? That question is just to make a point. I hope you see the point I’m making. Your registrar can be a valuable member of your team. You would be wise to consider what that particular team mate has to contribute.

Thank you very much for sending your good question to Ask The Experts.

Bud Salsbury, CQT, CQI

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

TS 16949 Conformance for a Non Value Add Company

Automotive inspection, TS 16949, IATF 16949

Question
We’re a fabless semiconductor company, Tier 2, who is in the process of designing and developing an automotive product to deliver through our TS 16949 certified subcontractor, Tier 3, to an auto supplier Tier 1, for an OEM.

We know and understand that we cannot get TS 16949 certified, but we are still working at bringing up our ISO 9001 processes certified for 14 years to withstand a TS 16949 audit.
As we do our internal process audits in preparation for our ISO 9001/14001 Surveillance audit in June/13 we’re looking for TS gaps which we’ll document and work to close.
We’re looking for a registrar who would audit us to TS 16949 and give us a report that basically states that, assuming we do, have withstood the audit and that if we were an Mfg’r qualified to be TS 16949 certified company that we would pass a TS 16949 audit.
Are you aware of any other companies who have done this or of any registrars who provide this type of service?

We’re either setting precedence for other fabless semiconductor companies designing to deliver for auto, or it’s already been done. If it has, then what is this type audit of called and do you know anyone who has done it?

Thanks for any input you may provide.

Answer
Thank you for your question. There are two issues here. Firstly, contact your existing registrar with this question and see if they can comply with your request.

Secondly, this is about your obligation to provide a proper PPAP submission for these parts, whether they are manufactured by you or by a supplier. If you are the supplier for these parts, there are likely terms and conditions in your Purchase Order that require you to submit a level 3 PPAP. If these requirements are present, they are auditable as a customer-specific requirement whether you are registered to TS 16949 or not.

I hope this answers your question.

Denis J. Devos, P. Engineer
A Fellow of the American Society for Quality
Devos Associates Inc.
Advisors to the Automotive Industry
http://www.DevosAssociates.com

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

Gap Analysis Vs. Pre-assessment for a Standards Audit

Audit, audit by exception

Question:
Can you clarify the difference between a gap analysis and a pre-assessment in relation to an activity that takes place prior to the full compliance audit? It is my understanding that a gap analysis compares something against a set performance level or standard requirement and an assessment is the collection and analysis of information to determine the projected compliance of an organization to a standard. Both provide the answer of what is missing, but the gap analysis also provides information on where an organization wants to be without going so far as to telling the organization how to get there (consulting).

Response:
Thanks for contacting ASQ’s Ask the Experts program. With regard to your question, the primary difference between a gap analysis and a pre-assessment is that a gap analysis applies to management systems such as ISO 9001:2008, ISO TS29001 or others. A gap analysis is typically the initial step in the QMS certification process. It is used to identify areas within a quality management system that do not meet defined requirements for certification. This can include processes, persons or product. The results of the gap analysis are based upon objective evidence, such as records reviewed, interviews conducted and observations made, to evaluate an Auditee’s conformance with requirements.
A pre-assessment is usually the initial phase of the accreditation process. A pre-assessment, or a practice assessment, is conducted prior to a conformity assessment to identify areas that must be improved or corrected before accreditation can be obtained. Unlike a compliance audit where the Auditor verifies conformance based upon objective evidence as mentioned earlier, an Assessor is also focused on assessing an organization’s competencies and performance of required tasks, such as measurement of uncertainty (MU), metrological traceability and proficiency testing (PT) as defined by ISO 17025:2005 and referred to by some as the “big three”.
A commonality shared by a gap analysis and a pre-assessment is that they both identify nonconformities or gaps between what exists and what is required by the standard or other defined criteria.
As you are aware, “gap analysis” and “pre-assessment” are not interchangeable terms. A gap analysis is associated with QMS certification or registration as issued by a Registrar and pre-assessment or practice assessment is associated with an activity performed prior to conducting a conformance assessment for accreditation. ISO 9000:2005 and ISO 17000:2004 provide vocabulary and terms for ISO 9001:2008 and ISO 17025:2005 quality management systems, respectively. Additional vocabulary and terms, as applicable to ISO 17025:2005, are provided in ISO/IEC Guide 99:2007, International Vocabulary of Metrology.

I hope this helps.

Best regards,

Bill

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
Kingwood, TX 77339
Website: www.astontechconsult.com

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

MSA Location Variation

Gage R&R, Torque Wrence

Question

Is it acceptable to use traceable standards (VLSI, NIST, etc.) to complete stability, bias and linearity studies if these standards cover the operating range of the gage? For stability and bias, the AIAG MSA 4th edition (p. 85, p. 87) states, “Obtain a sample and establish its reference value(s) relative to a traceable standard…” For linearity, the AIAG MSA 4th edition (p. 96) states, “select g>= 5 parts whose measurements, due to process variation, cover the operating range of the gage.” Specifically for designating a master sample (from production) to assess stability, we have an issue with degredation or oxide growth on the master sample that introduces known variation in thickness measurements. In this case, would it be justifiable to use VLSI standards to assess stability over time? Thanks for your help and guidance!

Answer

The quick answer is “that depends”.

The purpose of measurement systems studies is to evaluate the entire measurement system which includes the equipment, method, appraiser and the within part variability. The problem with using standards is that they are too good in that their reference value will usually be on an incremental value / discrimination point and not between points which require either truncation or rounding. Using standards can end up with average ranges of zero which is interpreted that the measurement system does not sufficient discrimination for the task.

Consequently I am disinclined to support the use of standards in measurement system studies.

However, it appears that this question is motivated by the need to look at the stability of the measurement system and actual parts will degrade over time. In this case we are not interested in the common cause variation but the existence / occurrence of a special cause. If the measurement system shows itself to be acceptable using normal parts then the stability of the system can be monitored using standards (at least 2 at the limits, preferably 3 with one in the middle).

If a bias studies on the standards have the overall range of 0 then ANY reading in a stability study using these standards other than the reference value indicates that the measurement system has changed.

If a bias studies on the standards does not have zero variability then things get a little tricky. Statistical control limits will probably not work unless this variability is not small (then the question become understanding why). You may have to resort to using the “precision” limits provided by the equipment manufacturer. Remember the objective is to be able to identify whether something changed (a special cause is affecting) the measurement system.

Greg

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