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Special Process NCRs During Audit

Welding, Weld, Processes, Automation

Question

Recently one of our business units had an ISO 9001: 2008 audit and during the audit they received a couple NCRs on welding as a special process.
One of the NCRs was “Some welders are not qualified prior to welding on product.”

As a matter of fact, our company has developed its own qualification program based on the our needs consisting of the following steps:
– The minimum requirement of least 2 years or more experience as a welder before starting the job.
– In class training for weld specifications, blue print reading, equipment, weld supplies, visual acceptance/ rejection criteria and equipment TPM program conducted by our QE.
– Hands on exam – the result of this test is reviewed by a QE and weld supervisor without performing any bend test, pull test or other types of DT.
– Annual recertification program based on a written exam and weld coupons visual inspection results.

The CB auditor is asking us to send the coupons out to a certified lab for bend testing or having all the welders certified by AWS. Is that required per ISO 9001? As a side note, every time we design and develop a new model we conduct all types of crash tests, FEA and durability testing in design validation phase.

Answers

From George Hummel:

I would not accept the auditor’s comments. He/she is consulting.

From Charles Cianfrani:

No. It appears that the CB auditor is adding requirements. The organization has a process, and if it is effectively implemented that should be satisfactory evidence of conformity.

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

Zero Acceptance Number Sampling Plans and the FDA

Pharmaceutical sampling

Question

There has been some debate over using the MIL-STD-1916 acceptance sampling plan over the ANSI/ASQ Z1.4-2003 (R2018) sampling plans. The opinion is that the ANSI/ASQ Z1.4-2003 (R2018) is outdated and no longer an acceptable method of determining a qualification sample plan and the MIL-STD-1916 should be used in place of ANSI/ASQ Z1.4-2003 (R2018). Do you have information around this debate over which sampling plans are acceptable by the FDA?

Answer

FDA does not (and can not) tell you what sampling plan is to be used. The FDA requirement is that the plan be statistically valid. As long as you follow the regulation, you are meeting FDA requirements.

In medical device manufacturing the key point is to have the plan accept on zero defectives. This point is not FDA but legalese. It is based on past lawsuits. The plan “Zero Acceptance Number Sampling Plans” by Nicholas L. Squeglia (available from ASQ) has been widely adopted for this reason.

ANSI/ASQ Z1.4 in not outdated and continues to be widely used. It is the American National Standard Institute (ANSI) version of MIL-STD-105 which the government discontinued maintaining, allowing ANSI to maintain it along with many, many other MIL-STD’s as a government cost reduction.

MIL-STD-1916 can be used but it is not widely used because of its difficulty and practical use.

James Werner

For more about this topic, visit ASQ’s website.

AQL Clarifications

Automotive inspection, TS 16949, IATF 16949

Question

I am confused about the values used for AQLs. For example in Table II-A the AQL values range from 0.010 to 1000. Where do these values come from and what do they mean?

The table states, “AQLs, in Percent Nonconforming Items and Nonconformities per 100 Items .” At first I thought the values were percentages, but how can you have more than 100, as in 100%, as the values go up to 1000? Also how can there be more than 100 nonconformities per 100 items, unless one part can have multiple nonconformities?

Just looking for clarification on the AQL numbers, what they mean, and how to interpret them.

Answer

Let’s start with the definition of Acceptable Quality Level (AQL). From Z1.4, the AQL is the quality level that is the worst tolerable process average when a continuing series of lots is submitted for acceptance sampling. Although individual lots with quality as bad as the AQL can be accepted with fairly high probability, the designation of an AQL does not suggest that this is necessarily a desirable quality level. The AQL is a parameter of the sampling scheme and should not be confused with a process average which describes the operating level of a manufacturing process. It is expected that the product quality level will be less than the AQL to avoid excessive non-accepted lots.

The columns with percentages greater than 100% should not be included in the standard, but remain as indication of how to interpret lots where the entire sample is defective. It has some statistical relevance with use of the switching rules, but for the general practitioner, it should be ignored.

Hope this helps.

Steven Walfish

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

Document Revision Criteria

ISO documentation practices, requirements

Question

Is there any criteria available for the frequency of document revision in ISO 9001 or ISO 13485? Some organization don’t revise the documents for a period of more than 2-3 years. The reason provided by the organization is that there were no changes during this period. Do ISO standards mandate the revision of documents within a certain time frame? Can we treat this as non-compliance, if the documents are not revised over a period of 2-3 years ?
Answer

There are no criteria nor a requirement for document revision in ISO 9001:2015, 7.5.

ISO 13485:2016, 4.2.4, states, “review, update as necessary and re-approve documents.” This leave the review to the discretion of the organization.

Thus, there is no mandatory review frequency and no non-conformance if documents are not revised within a determined time frame. ISO 13485 does require a review, however. But, the frequency of the review is not mandated.

George Hummel

Verification or Calibration?

Automotive inspection, TS 16949, IATF 16949

Question

There is a second part to 7.6 para “a” which reads; “where no such standards exist, the basis used for calibration or verification shall be recorded.” It is clear for shops that are complying to the ISO 9001: 2008(E) we need to have measurement standards traceable to international or national measurement standards. My question has to do with cylindrical plug gages that are used at the machines to verify manufactured print dimensions. The pins/plug gages are not sent out at intervals for calibration however, they are compared to a traceable measurement standard before being issued to the manufacturing area. We consider these gages to be calibrated “as used ” and we do not record the initial actual size of the pins/plug gage but issue it only on the basis that the size was verified against a traceable measurement standard. Are we required per Para 7.6 to record the actual size of the pins/plug gages?

Answer

Thank you for your question. What you are describing is verifying prior to use, rather than calibration. If the rings or other standards being used to check these plug gauges each day are properly calibrated and traceable to national standards, you are compliant with ISO 9001:2015. If you are registered to AS 9100 or TS 16949, stricter requirements will apply and you may not be meeting those requirements for recording variable results of calibration.

Denis Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951
www.DevosAssociates.com

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

Clauses 8.4.1 and 8.4.2 in 9001: 2015

Mr. Pareto Head and IT

Question

The insurance company I am temporarily helping on quality is limiting its ISO 9001 certified perimeter to the administration of contracts and claims.
With regard to clauses 8.4.1 and particularly 8.4.2 of ISO 9001:2015, should the other internal entities of the company (.i.e HR, IT, Sales Dept, …) absolutely necessary but outside of the perimeter be considered exactly like external providers – just like a provider of IT, for instance – or should they be considered as internal providers with a limited control of their contribution to the QMS through a simplified SLA? Of course, SLAs will be put in place in order to secure the relationship of these internal entities with the perimeter.

I thank you in advance for your help/interpretation of clauses 8.4.1 and 8.4.2 applied to the case submitted.

Answer

Thank you for your question. Yes, that is an appropriate interpretation, but let me add three comments.

Firstly, recognize that your support functions are captive within your organization and therefore not subject to all of the same conditions that would be imposed on an outside service provider. For example, you can’t stop doing business with them if you are not happy with their service. I like your idea for an SLA – keep it simple, but outline your requirements and expectations for their support services.

Secondly, use your process approach (clause 4.4) to define the boundaries of your QMS and how those other external departments interface with you. This will be helpful in helping your team and others to understand the relationship between your QMS and the rest of the organization.

Thirdly, take advantage of the Context of the Organization analysis (clause 4.1) to further explore those relationships and that will help to determine the level of control you require over those support functions.

Denis Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951
www.DevosAssociates.com

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

Approved Supplier List 17025 or 9001?

Question

Every once and while our company will need to find a rare or hard to find item on the web. Due to the rarity of the item we sometimes need to look at sites that are not a typical supplier. So how would you go about approving a supplier such as Amazon or EBay since they are more like a distributor then a supplier and utilize a large pool of other retailers/sellers?

Answer

I think ISO 17025 is not the correct citing; ISO 9001: 2015 Section 8.4. would be a better fit.

Approving a distributor is meaningless whether the distributor is Amazon or EBay. The requirement is under Section 8.4.1 of ISO 9001: 2015. Consider that the supplier is the manufacturer of the item (product) being bought on the web. The user needs to approve the use of that item – not the supplier.

The last paragraph under Section 8.4.1 reads, in part: The organization shall determine and apply criteria of the evaluation, selection, and monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in according with requirements. This means that the organization determines the requirements, documents those requirements, and follows the establish requirements. The requirements here, I suggest, are to approve the supplier based on the supplied item meeting the organization’s needs – specifications.

For example, Home Depot or Lowes is a distributor (source) of a hex-nut that is infrequently used. The hex-nut has a specification, thread size, length, etc. The requirement then would be that an inspection of the hex-nut confirms it meets the predetermined requirements. This is all documented.

James Werner

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

Z1.4 Sample Size

Pharmaceutical sampling

Question

I am trying to determine the sampling size using my ANSI/ASQ Z1.4 table and I wanted to get some clarification. If I am using Table II A and my Sample Size Code letter is D, what would be my sample size? If it falls on an arrow does it mean that I have to change to the next sample size based on where the arrow points?

Answers

From Charlie Cianfrani:

If you are using Z1.4, your sample size is selected based on your lot size. You would pick the AQL you need based on the risk you are willing to take for the process average of percent defective. It is important to understand what you are doing when using sampling plans, what they are and the protection you are trying to ensure. Thus, the important step is to determine the AQL. Then you select the sample size to provide the level of protection you are striving to ensure. It is more important to understand the theory behind the tables than to mechanically use the tables.

From Fred Schenkelberg:

Use the sample size where the arrow points. In the 2008 and 2013 versions it explains this in section 9.4, “When no sampling plan is available for a given combination of AQL and code letter, the tables direct the user to a different letter. The sample size to be used is given by the new code letter, not by the original letter.”

From Steven Walfish:

The standard sample size for Code Letter D from IIA is a sample size of 8. But depending on your AQL, a sample size of 8 would be inappropriate, so the standard has arrows to delineate alternative sample sizes to reach the target AQL. So, you sample size and accept/reject values are changed. For example, at an AQL of 0.25, you would move down to a sample size of 50, with an accept/reject of 0/1. If the lot size is less than 50, you would need to do 100% inspection. In other words, there is no sampling plan that can give an AQL of 0.25 without a minimum sample size of 50.

From James Werner:

Yes. When using Z1.4 two items need to be known, lot size and the AQL (Acceptance Quality Limit). You use Table I – Sample size code letters to determine the Sample size code letter based on the Lot or batch size. In the question below that was determined to be “D”. Next step is to use Table II-A to find the sample size related to the sample size code letter – D and the AQL. On Table II-A go across the table’s row for letter D until it intersect the given AQL column heading. If an arrow is in that intersection point, follow the arrow then go back to the sample size code letter column to find the actual sample size (if a up/down arrow is in there then you choose).

Example 1. Code letter is D (as in the question below). Let’s say the AQL is 0.25. Starting at code letter D, move across that row until you intersect at the AQL 0.25 column. There’s a down arrow this row/column intersection. Follow the arrow downward until the “Ac Re” reads ” 0 1″. Staying on this row go back to the Sample size code letter column and find Code Letter H and Sample size = 50. This means for the lot size with code letter D and with an AQL of 0.25 the sample size = 50 and accept the entire lot if no nonconformances were found else reject the entire lot if 1 or more nonconformance were found in the sample.

Example 2. Let’s say the Sample size code letter was determine from Table I to be “F”. Looking at Table II-A; If the AQL = 0.65, then the sample size would be 20 and the lot would be accepted zero nonconformance. But if the AQL = 0.15 then the sample size would be 80.

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

Cleanrooms, Classes, and Control Charts

Sterile, Lab, Clean Room, Requirements, Standard

Question

My question has to do with cleanroom monitoring, specifically particle counts. Using ISO 14644-1: 1999, (we are still transitioning to the new standard), we have 27 test sites in our cleanroom. Our Particle Counter takes 10 readings per minute and averages those readings into one value. This is the number we record at each of the 27 test sites. Since an ISO Class 8 Cleanroom can have no more than 3,520,000 particles greater than 0.5 micron in size per cubic meter, for the room, do you add all 27 results and compare to the acceptance criteria? Do you average all 27 results and compare to the acceptance criteria? or as long as each individual result is below the acceptance criteria we are in compliance? what makes me think you add all results together is that the acceptance criteria states: ISO Class 8 Cleanroom can have no more than 3,520,000 particles greater than 0.5 micron in size per cubic meter, for the room. Your input would be greatly appreciated!

Answer

The way for analyzing these data is very straightforward. Considering you have continuous data, the most appropriate way for accomplishing this is by using a control chart. Use the 27 readings for constructing the averages needed for a control chart. Identify control limits and respond to special cause variation only. You will know that you are in compliance as long as your control charts remain under control. If you ever find any points out of control, you may want to quarantine the product processed during that time and conduct the appropriate corrective actions. As your regular housekeeping, keep the cleanroom certification current. The same for the particle counter system calibration.

If you are new to control charts, the easiest/simplest reference I have ever found is Understanding Variation – The Key to Managing Chaos by Donald J. Wheeler.

Based on your data performance, you may also be able to identify areas within your cleanroom that perform better than class 8 (7 or better). Knowing where those areas are may be handy.

Regards,

Aura Stewart

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

Customer Satisfaction

Gage R&R, Torque Wrence

Question

The question is about 9.3.2.1 in IATF 16949. It said the input to management review shall include (f) customer satisfaction. Because that clause is supplemental to ISO 9001, 9.3.2, where C (1) customer satisfaction and feedback from relevant interested parties is inclusive, why does it repeat here? I asked to see 9.2.1 in ISO 9001 but I didn’t see any specific difference between them.

Answer

That’s a very good question, and you’re right that it’s a subtle difference. It seems that the reference to clause 9.1.2 in the 16949 clause 9.3.2.1 makes it very specific and deliberate that the customer satisfaction being referred to must include “perception” (9.1.2) and that the customer satisfaction in management review will be derived from how “the organization shall determine the methods for obtaining, monitoring and reviewing this information” (9.1.2). I hope you find this clarification helpful.

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951
www.DevosAssociates.com

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