“As received/As found” Condition Requirement in ISO/TS 16949?

Automotive inspection, TS 16949, IATF 16949

Question

It’s been mentioned to me by several people that TS16949 requires that the “as found” (sometimes known as the “as received”) condition is required to be documented on calibration certificates. However, I’ve read 7.6.2 several times and I can’t find where it requires that.

Can you point me to the section that is being understood to mean the “as found” must be included?

Answer

Thank you for your question.

Although recording the as-received readings over the range of calibration is a best practice, it is not required by ISO/TS 16949.  Clause 7.6.2 – Calibration/Verification Records requires only that “records……shall include, any out-of-specification readings as received for calibration/verification.” Therefore, “as found” readings are only required to be recorded if they are out of specification. If they are within specification, they are not.

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

Using White Out on Controlled Documents

ISO documentation practices, requirements

Question

During our certification for AS9100C the auditor found some documents with correction liquid that we have used for years. We have prohibited the use of any type of correction on all processes company wide.

It is common that during the prototype stage we performed dozens of changes due to the differences between the calculating/design program (electrical) and what happens in real life. During those adjustments we change manually circuits, values, etc. from the original version, with white-out tapes (before was liquid paper) once the prototype works those changes are incorporated as “Initial release” in the package that goes out for manufacturing. Do you guys see any problem using white out tape / correction tape on the controlled copies during prototype stage? My point is that the original values are recorded on the originals that will be obsoleted and the new ones on the initial release, keeping the controlled copies marked as records of the prototype.

Response

Thanks for contacting ASQ’s Ask the Experts program.

With regard to your inquiry, changing the documented results of inspection or test activities should be avoided or at least strictly controlled.  This is of special importance if these records are intended to provide evidence of product or process conformance.

However, prototype test results which may be subject to frequent changes during preliminary inspection or test activities, doesn’t require the same level of control.  These results are usually intended for informational purposes only and not for final acceptance of a process or product.

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

Nonconformance Versus CAPA Requests

CAPA process, CAPA requests

Question:

I need advice on the use of Nonconformance versus Corrective Action/Preventive Action (CAPA) Requests. I understand and have tried to communicate the low risk and high risk definitions to staff with some understanding. In reporting nonconformance’s some evolve into a root cause analysis which is a positive direction but thought to be a requirement of a Corrective/ Preventative Action. Nonconformance’s are logged on a report and reviewed periodically. CAPA Requests are more elaborate; logged and reported on a metrics with continuous review.

Response:

My answer may seem lengthy but I feel defining things is important. First, here is part of a memo I put together for one company.

ISO terminology and definitions – Corrective action/Preventive action

Some people experience confusion over the differences between corrective and preventive action.

We know that corrective actions are taken to remove the causes of existing nonconformities.

If the nonconformity is detected during production, immediate corrective action is taken to eliminate the problem. In other words, we fix what went wrong. We take preventive action to ensure the same problem does not happen again. However, this is still corrective action because it is based on solving a problem that has already happened.

We might use documents or electronic forms to report/record such actions. Here, caution is advised. For example, if a machinist turns a part undersize, immediate corrective action is taken to fix the mistake and further action is taken so it doesn’t reoccur on subsequent parts. If the original “bad” part was scrap and we record that as a non-conformance in our documentation, with the corrective action noted, we might then close that record. We might then request a follow up with preventive action. That would be a mistake.

Note: Not every problem or non-conformance requires a corrective action. This is determined on a case by case basis, usually by a manager. Each case is different.

Example: A welder accidentally causes weld spatter to fly into a tapped hole. The welder cleans out the B-B’s, re-taps the hole and moves on. Generating a non-conformance form should not be necessary in this case as no product was scrapped or made nonconforming.

Now, let’s say an employee sees a potential problem.

Example: The employee notices the jaws of a turning center are showing very obvious/significant run-out.

This could potentially result in nonconforming product. This is a good case for preventive action. A change request could be generated and when the action is taken, it can be followed up on (verified) and recorded in the appropriate format. In most cases, over an entire year a company will record very few Preventive Action Requests (PAR’s). However, that same organization will register numerous Corrective Action Requests (CAR’s). This is the normal rhythm of things and is what we strive for.

Here are a few definitions for your files. The following Terms and Definitions are taken from ISO 9000:2005:

3.6.4
Preventive action: Action to eliminate the cause of potential nonconformity or other undesirable potential situation.

NOTE 1 There can be more than one cause for a potential nonconformity.
NOTE 2 Preventive action is taken to prevent occurrence whereas corrective action (3.6.5) is taken to prevent recurrence.

3.6.5
Corrective action: Action to eliminate the cause of a detected nonconformity or other undesirable situation.

NOTE 1 There can be more than one cause for a nonconformity.
NOTE 2 Corrective action is taken to prevent recurrence whereas preventive action (3.6.4) is taken to prevent occurrence.
NOTE 3 There is a distinction between correction (3.6.6) and corrective action.

3.6.6
Correction: Action to eliminate a detected nonconformity.

NOTE 1 A correction can be made in conjunction with a corrective action (3.6.5).
NOTE 2 A correction can be, for example, rework.

I hope this has been helpful.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Additional ASQ Resources:

Form by Design
Using flowcharting techniques for robust form design
by Lance B. Coleman

Corrective Action Challenge
How to construct a robust problem-solving process
by R. Dan Reid

CAPA for the FDA-Regulated Industry (book)
Abstract: Medical devices, biopharmaceutical, and traditional drug manufacturing companies devote an important part of their resources to dealing with incidents, investigations, and corrective and preventive actions. The corrective and preventive action system is known as the CAPA system. It is second to none in terms of frequency and criticality of its deviations, and most of the regulatory actions taken by the FDA and foreign regulators are linked to inadequate CAPA systems. This guidance book provides useful and up-to-date information about this critical topic to thousands of engineers, scientists, and manufacturing and quality personnel across the life sciences industries.

Understanding and improving the CAPA system as a whole is the focal point of this book, the first of its kind dealing exclusively with this critical system within this highly regulated industry. By helping those in this industry improve their CAPA systems, it will be a crucial aid in their mission of producing safe and effective products.

ISO/TS Exclusions

Manufacturing, inspection, exclusions

Question:

I have a question regarding exclusions from the ISO/TS standards.

The majority of our business is the design and manufacture of enclosure hardware.  Recently though, a small portion of our business has become the sole North American Distributor for an Italian company. Their product lines are similar to ours. However, we procure their products and simply resell/distribute to their customers stateside, to Canada and Mexico. We do not have Design or Process Control for these items; they are pass-through product.

Therefore, my question is related to permissible exclusions from the ISO standard. Should we seek exclusions regarding certain clauses of Clause 7 of the standard, for this certain “supplier”, and/or for certain product groups that are sold on their behalf?

Response (Answered by Bud Salsbury):

At first, your question seemed relatively uncomplicated and I am inclined to say that you can simply sell or provide the products in question with a disclaimer or something identifying the fact that your company is not the designer/manufacturer of the product.  My company occasionally has purchased parts inserted into or added to the products made. Like bushings or threaded inserts, etc. We don’t have to add anything to our QMS for those as long as those items meet regulatory and statutory requirements.

However, I should mention, the standards make it clear that exclusions are permissible if “such exclusions do not affect the organization’s ability or responsibility to consistently provide product that meets customer and applicable statutory and regulatory requirements.”

Therefore, stepping away from the initial ‘simple’ answer, I would say that such exclusions would not be permissible. This is due to the fact that your organization is ultimately responsible for meeting customer requirements. Although you do not design or manufacture that specific product, you provide, and are responsible for what the customer requests.

You are also responsible for seeing to it that the OEM is meeting customer as well as any statutory or regulatory requirements. This would be of particular importance if these are electrical enclosures or intended for hazardous services, such as NEMA 7 (explosion proof enclosures).

Since you already design and manufacture your own products and have the Clause 7 included in your QMS, it would be counterproductive to add more documentation to exclude what you have mentioned. It would be wise to notify customers up-front, in the sales/purchase order process, that the product you are distributing is from a separate company.

Thanks much for this good question.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Follow Up Questions:

• IF there were permissible exclusions allowed, WHO would need to ‘approve’ these or ‘allow’ them to be exclusions?  Would that be the registrar or someone else?

• IF there were permissible exclusions, would it be stated/depicted on the actual Certificate as such or only noted in the quality manual, for example?

• IF there were permissible exclusions, would it be an exclusion of the ISO CLAUSE?  And/or PRODUCT?  And/or  SUPPLIER?

• Currently we list “the design and manufacture…” in our scope.  Would we need to revise the scope to include ‘distribution’?

Response (Answered by Denis Devos):

Thank you very much for your question and your follow up.

In further response to your original question – if you are in the automotive industry, you will still be obligated to provide a Level 3 PPAP (as a default) to your customer for the product you are purchasing and reselling; whether you are design and process responsible or not.

Permissible exclusions are only granted for Clause 7.3 Product Design.  Per TS 16949, you cannot be excluded from the requirements of Clause 6.3 related to process design.    You can declare this exclusion yourself in your Quality Manual and your registrar will validate your claim during your registration audit.   The exclusion will appear on your registration certificate.  You can only be excluded from Clause 7.3 Product Design, (not process design).

Under TS 16949, you cannot exclude products from your registration if they are being sold to the automotive industry.   Sometimes, a registrar will permit only a portion of your business to be registered and that would be reflected in the scope on your certificate:  Check with your registrar.   You cannot be exempted from any requirements related to supplier management, such as Clause 7.4.

Yes, you will likely have to include “distribution” in the scope of your registration; check with your registrar.

I hope this sufficiently answers your follow-up questions and you find this advice helpful.  If you need anything further, please don’t hesitate to contact us.

Best Regards,

Denis J. Devos, P.Eng
ASQ Fellow
Devos Associates Inc.
London Ontario
www.DevosAssociates.com

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

Ask A Librarian

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

AS9100C

Airplane, aerospace, AS9100

Question:

Question: The AS9100C, which is an expansion of the ISO 9001:2008, states that a “process” based system is being promoted as is shown in 0.2 of the Introduction.  Why are 3rd party auditors being required to use the AS9101 Quality Management Systems Audit Requirements for Aviation, Space and Defense Organizations checklists for their audits?  These check lists are not “process” based and go back to the old procedure systems of the 1994 standard.

Each of our core processes consists of a flow chart of the process, process turtle and PEAR.  If you were doing a true process audit you would take these documents and perform the audit and not limit the auditor to being “boxed in” by a check list.  If the QMS has been developed correctly the process approach audit will allow you to cross other processes when being performed.

Response:

Thanks for the question.  The IAQG AS9101 Team does firmly believe in promoting the process approach which you will see reflected with the next AS9101 revision.  I agree that auditors should follow the process while performing all auditing (including 3rd party audits), yet it is also important to ensure that all the AS9100 requirements are satisfied.  That is why AS9100 auditors are trained to audit the process and then complete the Objective Evidence Record to ensure all AS9100 requirements are fulfilled.

Thanks,
Buddy Cressionnie
Americas 9100 Lead

What Title Do You Associate With a Quality Department?

Data review, data analysis, data migration

For this post, I invite subscribers to give their feedback regarding a recent question that came through today.  We have an industry member that is looking into the possibility of changing his department from Quality Improvement to… that is the question.  When you think of a quality department, what title do you associate with it?  Quality Management?  Quality Assurance?  Quality Improvement?  Something else?

Using A3: Toyota’s Process Improvement Tool

A3 report, Toyota A3, problem solving A3

Q: I’m interested in obtaining more information about A3, a process improvement tool created by Toyota.  Do you have any resources that explain the ways to use A3 or offer a template?

A: Thank you for contacting ASQ.  I found the following case studies regarding the use of A3 by other organizations that I think might be helpful:

Abstract: Toyota created A3 reports as a means of identifying and solving problems. These reports, printed on a single sheet of paper, are an effective tool because in addition to text, they contain pictures, diagrams, and charts to improve communication. However, no study has as yet been published explaining how to implement A3 reports in manufacturing. This study examines how A3 reports were implemented in a successful process improvement project in aircraft maintenance and repair operations. The duration of the improvement effort is approximately four weeks and is divided into four distinct phases. Additional research is suggested to demonstrate the effectiveness of A3 reports in reducing waste and creating value.

Abstract: Todd Schneider, a certified public accountant turned executive champion for continuous improvement (CI), has helped integrate CI/lean into the operations of two companies. Lessons learned in his quality journey include the importance of training and communication and strategies for gaining upper management’s support. Reports on two CI/lean projects at Schneider’s current employer, Serigraph, show how the company has used Six Sigma to improve yield by more than 20 percent, saving $40,000 in the first 10 months, and improve vendor material management, saving $192,000 per year.  Provides a blank A3 form that was used by the company in the case study.

There is also an inexpensive ASQ web-based training session available on A3 reports:

Learn the A3 report’s history, its benefits, and how to complete a successful form.  The course is ideal for anyone involved in a lean project, especially supervisors.

Please feel free to contact me with any questions or if you need additional assistance.

Best regards,

ASQ Research Librarian
Milwaukee, WI

QMS Documentation Management

About ASQ's Ask the Standards Expert program and blog

Q: I was wondering if ASQ has any good information on managing QMS documentation.  My company is working right now on finding a solution for a better way to manage QMS documentation.  We have previewed some QMS document management software but think we can do all of the programming in house with Microsoft SharePoint. If you have any suggestions I would love to hear them.

A: Thank you for contacting ASQ.  According to The Quality Improvement Glossary by Donald L. Siebels, a quality management system is “a formalized system that documents the structure, responsibilities, and procedures required to achieve effective customer satisfaction levels”.  The ASQ Knowledge Center has over 100 resources on the topic of quality management systems and documentation.

  • One of ASQ’s resources that you may find particularly helpful is a recent case study on a company that used a wiki to document its QMS:

Geometrica Builds ISO 9001 QMS on Wiki

For more information, please see the references listed at the end of the case study, including the following:

“After Geometrica attained ISO 9001:2008 certification in 2009, it wrote—and improved—this case study on a wiki. Visit Geometrica’s “living” case study

  • A little older resource, but this eBook might be helpful:

The Practical Guide to People-Friendly Documentation

  • You may also want to take a look at this October 2010 Quality Progress article:

Get Your Ducks in a Row: A step-by-step guide to implementing an ISO 9001 quality management system” (See section on “Gathering, managing information”)

 (See section 4 on Documentation)

I hope that this information is helpful.  Please feel free to contact me with any questions or if you need additional assistance.

Best regards,

ASQ Research Librarian
Milwaukee, WI