March 2017 -

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.

“Shall Be Determined” in 9001

Certification, ISO 9001

Question

Many of the Quality Management Systems requirements in the ISO 9001: 2015 standard include the verbiage “shall be determined.” I need to be sure that I understand exactly what this means in this context. For example, “4.4 QMS and its processes 4.4.1 a) The inputs required and the outputs expected of the QMS processes are determined.” Does this mean that there should be process or work instruction written describing this? Does it mean that there should be documentation showing the development of this information?

Answer

Thank you for your question. It might be useful to look at the definition of the word determine. According to the Oxford Dictionary: Determine means to “Ascertain or establish exactly be research or calculation”, Merriam Webster has a similar definition: “to find out about or come to a conclusion about by investigation, reasoning, or calculation.

Now to your question. There does not need to be a procedure about how things are determined. The output, or the determination itself, will serve as evidence that you did it. But determine things in an honest way. You and your CB auditor will assess the reasonableness of your determinations based on the context of your organization. For example, if you are a hospital, and you “determine” that surgeons do not need to wash their hands, you should be subject to a nonconformance for getting that wrong. In your example, taken from clause 4.4, the best way to do this is to create a flowchart(s) showing a series of process steps and their interactions. The arrows in and out of each box along with explanatory text, will demonstrate that you have determined the inputs and outputs of each process step.

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.