Jim Werner Archives -

Rounding Numbers and Specifications

Automotive inspection, TS 16949, IATF 16949

Question

If I have a data collection form and the data inputs are whole numbers, should the report then use rounded whole numbers rather than to 2 decimals points? I’d like to be accurate.

Answer

It depends on the specification. If the specification is a whole number, then each reporting value should be in a whole number. The issue comes in when inspection, measurement, and test equipment (IM&TE) gives a read-out in decimals, as they should. (remember the requirement that the IM&TE should be more accurate than the desired result).

For example: if the specification is XX, then the test result should be reported in XX. If the specification is XX.X, then the result should be reported in XX.X (one decimal place).

Not doing so can lead to problems. If the specification is, for example 8 – 10, then a result of 8, 9 or 10 is passing. If the IM&TE gives a result of 10.1 and you record 10.1 then you open the door for interpretation by others. The best thing to do is define the recording of test results in the test procedure / method.

Once when I was being audited, the ISO auditor claimed that the company was accepting out-of-specification test results. The specification was 0.01 max. The test instrument gave a digital read out in the 4th decimal place and the technician record all 4. The test result was 0.0102. The auditor claimed that was over the max or 0.01. Boy did I have an argument with him (I won). After that,the technicians were trained to round to the readings and record only to 2 decimal places (i.e. significant digits) This was also added to the test instruction.

James Werner

Process Review Requirement in 9001?

About ASQ's Ask the Standards Expert program and blog

Question

Is there a requirement in the new ISO 9001:2015 standards for annual monitoring/reviews of processes? What are any such requirements for process reviews?

Answer

First, there is no requirement to do anything annually. Rather it is an expectation to do certain things such as calibration at least annually. The subject requirement is in section 9.3 Management review. Specifically section 9.3.2 Management review inputs includes at part (3) “process performance and conformity of product and services”.

What is commonly done is to create key performance indicators (KPIs) for each quality system process and these KPIs are periodically reviewed (at least annually) during a management review. Any process not meeting its KPI is looked into for improvement.

James Werner

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

Internal Auditing Roles?

Manufacturing, inspection, exclusions

Question

I’m quality manager for R&D department and have several persons as Software Quality Assurance for our software development process. My question is can I act as Internal Auditor to audit the compliance of ISO 9001: 2015 requirements and the software development process execution?

Answer

Let’s look at this differently. Say you are the quality manager and have several persons doing final product testing in a test lab. Clearly you are not impartial – you have a responsibility of the persons doing the testing. Since you cannot be impartial, you cannot act as the internal auditor or even be on the auditing team.

James Werner

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

ISO 9001 and M & A

Reporting, best practices, non-compliance reporting

Question

I would like to know how ISO 9001 management system could facilitate a merger & acquisition. By speaking a common language and using the same exigencies, do you think ISO 9001 could facilitate this type of operation?

Answer

I’ve done this in the past but not with ISO 9001, instead using FDA Part 820 Quality System Regulation. I created a checklist from the regulation and then audited the facility being merged / acquired. This was done to determine the state of the quality management system and what needed to be done (including costs) to ensure the facility was in compliance.

James Werner

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.

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.

Audit Timeline

Employees, Training, Working, Learning, Duties, Tasks, DFSS, Innovation, Audit, Auditing

Question

What is the ASQ recommended time frame between an auditee receiving a final audit plan and the audit commencing at the auditee’s site?

Answers

From Charlie Cianfrani:

ASQ does not have a recommendation!

From George Hummel:

This is not an ASQ requirement. A CB generally sends an audit schedule/plan three weeks before the audit.

From Jim Werner:

Typically, the final audit plan has been agreed to by both the auditor and the auditee and it includes the date(s) the audit is to take place. This means that the audit plan includes the audit schedule in one document. There are many books written, with examples, on this topic. The ASQ Audit Division is a good source.

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

Is Certification Revocable?

Data review, data analysis, data migration

Question

If a company is ISO 9001: 2015 certified, is it revocable?

Answers

From Jim Werner:

A company can indeed have its certification revoked. Being certified means the company has established a qualify management system that meets the requirements of ISO9001:2015. The failure of the company to continue to meet those requirements can result in de-certification.

From George Hummel:

Most CBs will revoke a certificate if the client does not answer an audit non-conformance. Their contract may define other instances. The questioner should review his or her organization’s contract.

From Charles Cianfrani:

Certified companies receive surveillance audits periodically. If the company fails to maintain compliance with ISO 9001:2015 requirements, eventually (after a series of intermediary steps related to resolution of nonconformity have been unsatisfactorily pursued) their certification can be voided.

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

ISO Certification and Suppliers

Mr. Pareto Head and Supply Chain comic strip

Question

I work for a small family company that purchases items and potentially processes or packages them into heat protection materials. One of my existing customers is asking for ISO certification for some materials that I will sell to them. The material I’m trying to sell him comes from my supplier who is ISO 9001 certified, but my company is not. How can I show my customer that my supplier is ISO certified without the customer knowing who my supplier is?

Answers

The company is doing a value added process, and not a distributor. As a result, if the customer is demanding ISO 9001 certification from the company, they need to make the decision, do they want to do business with the company? If so they need to pursue certification. If they do not want to pursue certification, they should tell the customer they do not want to pursue certification. The customer can make the decision whether they will purchase product from the company. I have had an experience where I did not want to do an audit with a company. We told the customer, we will not do it. The customer responded and came back with a reasonable proposal. They wanted the business.

John G. Surak, PhD
Surak and Associates
Clemson, SC
A member of Stratecon International Consultants
www.stratecon-intl.com/jsurak.html

First, ISO certification is for a company’s quality management system, not for particular materials. I would let the customer know, on company letter head, that: “We certify that the materials we purchased are from ISO 9001 certified suppliers only. The name of these suppliers is company confidential.”

James D. Werner
Principal Consultant
MDQC
Medical Device Quality Compliance, LLC

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