AS9100 D and ISO 9001: 2015

Airplane, aerospace, AS9100

Question

Is there a document that compares the requirements of AS9100 D against the requirements of ISO 9001:2015?

I am looking to update our system to AS9100 D, and have the standard, however it would be helpful to have a document to help identify the gap between the two.

Answer

ISO 9001:2015 is embedded in AS9100D as the baseline.  If you look at AS9100D text…the regular text is ISO 9001:2015 text and the bold-italics text are the additional Aviation, Space & Defense text.  So what you are looking for regarding the additional requirements is the bold-italics text.

I hope this is helpful.

Buddy Cressionnie
9100 Americas Leader

Escalation Process and ISO 9001: 2015

Chart, graph, sampling, plan, calculation, z1.4

Question

I have created a project and problem escalation pyramid to help associates understand when and who is involved when a project or process issue needs escalation. I would like to know what clause in ISO:9001-2015 this would fall into?

Answer

Thank you for your question.

It sounds like you have created an escalation process for when outcomes don’t meet requirements.  In this case it sounds like ISO 9001 Clause 8.7 “Control of Nonconforming Outputs” would apply.   If the escalation process is specific to something like an engineering design process, then Clause 8.3.2 “Design and Development Planning” and/or Clause 8.3.4 “Design and Development Controls” could apply.

Also, in a general sense, if a process issue needs escalation, it’s part of the plan-do-check-act cycle described under Clause 4.4 “Quality Management System and its Processes”.

I hope you were able to find these references useful.

Denis Devos

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

ISO 9001: 2015 and “Effectiveness”

Control chart, data, analysis

Question

ISO 9001:2015 references measurement of “effectiveness” throughout the standard. My question is what methods/techniques are typically used to measure “effectiveness”? Is it purely a quantitative analysis of metrics, or does it also involve subjective evaluation that may not be driven by statistics or metrics? Also, is it expected that effectiveness be measured for each process/procedure?

Answer

Thank you for your question.

Let’s begin with the definition of effectiveness from ISO 9000:2015.

Effectiveness is “the extent to which planned activities are realized and planned results are achieved.”  This definition requires that you know what the expected outcome (or objective/target) you want for a given task, project or process.  The first step is to know what you want to achieve, and then ask yourself what would be the best means to determine the extent to which that objective was met?

Yes, it is expected that effectiveness be (suitably) measured for each process. This is at the heart of the Plan-Do-Check-Act cycle.  Also, please read ISO 9001 Clause 4.1 and Clause 0.3.

As far as quantitative vs. qualitative metrics are concerned, you will have to decide what best measures the outcome of the process.  Also consider the cost of data collection.  Often, easy-to-collect qualitative data can suffice.   And don’t be deterred if quantitative data cannot be obtained.  As Dr. Deming so wisely stated: “Sometimes we have to settle for inexact measures of exactly the right things”.

Denis Devos

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

ISO 9001: 2015 and Vendor Certification

Suppliers, supplier management

Question

We are ISO 9001:2015 certified and have a sole source vendor who is considering dropping their ISO certification. What is the best course of action to retain this vendor if they drop their ISO?

Answer

Thank you for your question.

Unless you are in an industry where you are required to have your suppliers registered to ISO 9001, (for example, the automotive industry under IATF 16949), or you have specific customer contracts which require this,  the choice is entirely yours whether or not your suppliers are registered to ISO 9001.

If your company wants to press the issue and require ISO 9001 as a condition for this supplier to continue to do business with you, be prepared for them to give you up as a customer.   If however, this is a valued supplier with a history of strong performance, you don’t want to dismiss a valued supplier partner.   If you decide to keep them, simply change your purchasing procedure to allow yourself the latitude for management to approve and use suppliers without ISO 9001 certification.

Denis Devos

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

 

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 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  (KPI’S) for each quality system process and these KPI’s are periodically reviewed (at least annually) during a management review.  Any process not meeting its KPI is looked into for improvement.

There are many articles and books written on this subject and available on the web.

James Werner

Click here for more information about KPIs and here for information about management reviews.

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

Click here for more resources about internal audits.

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

Nonconformance Disposition

Chart, graph, sampling, plan, calculation, z1.4

Question

Should the person writing a non-conformance also be the person who dispositions the same non-conformance?

Answers

From John Surak:

This question is interesting.  In addition, there may be a lack of information to properly answer the question.  There is nothing in ISO 9001:2015 that prohibits the person who wrote the non-conformance from ensuring that non-conformance is addressed in an effective manner.  However, several questions remain.  Why did an individual write a non-conformance on one’s self?  Why did the person just take actions to eliminate the non-conformance without having to implement a correction or corrective action process?  This issue would be an interesting discussion during an audit, and it may lead to an audit trail that discusses leadership and commitment.

John G. Surak, PhD

From George Hummel:

This answer depends upon how you define “dispositions.”  If you mean take the corrective action, then no.  If you mean determines the effectiveness and evaluates the results, then yes.

Click here for more resources about nonconformances.

 

ISO 9001: 2015 Clause 8.3.4 and Product Design

 

PLCs, programmable logic controllers

Question

My company is implementing ISO 9001:2015 and my question is regarding Clause 8.3.4 d. Our company designs product for only 20% of our customer base. We do not have a validation process. We do send a prototype to the customer to test the part for a period of time to approve the design. In determining the scope of our organization, can we exclude the validation process and still become ISO 9001:2015 certified?

Answers

From John Surak:

This organization is involved in product design.  Therefore, the product design cannot be excluded.  However, the organization needs to review the validation clause.  8.3.4d states the following:   “validation activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use.”  It should be noted that neither 8.4.3d not the validation refences in ISO 9001 do not prescribe a method on how to conduct validation.  It would appear that the company has some sort of process they use to develop the prototypes.  This process should be codified or documented so that it is done in a consistent manner and in a way to ensure that the customer needs are met.

John G. Surak, PhD

From George Hummel:

Basically, you are outsourcing validation.  Therefore, you need to control that process per 8.4. I would not accept the exclusion. In the future, you may have a customer that requires you to do the validation. However, the final answer would be provided by your certification body.

Click here for more resources about ISO 9001: 2015.