Customer ISO Status In Jeopardy?

Question

My customer wants to get ISO 9001:2015 certified. He refuses to create a first-article, in-process, and final-inspection report. He has a router sheet that has a tiny space for final inspection brief information and the operator’s initials; no inspection data is available.
In his quality manual and processes he addresses “Time Studies” and “Statistical Process Control” but he refuses to record his inspection data because this “complicates and delays” his production. I told him this is a weakness in his QMS but he says it’s not. Will this issue jeopardize his ISO certification?

Answer

I would ask how the organization could present objective evidence with the requirements of Clause 8.5.1 including  – ‘shall implement production and service provision under controlled conditions.’

Charlies Cianfrani

Special Process NCRs During Audit

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 equipotent 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 recert. 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.

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.

ASQ/ANSI Z1.4 is available for purchase in PDF as well as hard copy.

Audit Timeline

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.

Is Certification Revocable?

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.

ISO 9001: Product Development and Customer Satisfaction

Manufacturing, inspection, exclusions

Q: Does a company certified to ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements that produces raw materials for a customer according to their written specification also, as a raw material supplier, have a responsibility under ISO 9001 to meet the customer’s needs for their design intent and intended and known use?

In simple language, I sell a raw material to a customer who takes my raw material and then designs a product and sells it to a customer who uses it in the field. I wonder where does the ISO standard application stop for the raw material supplier?  How can a raw material supplier under ISO 9001 meet the needs of a customer’s trade secret designs, or further down the intended use of the product where the raw material supplier has no control over how it will be used or maintained?

A: Your question is more a legal one than a quality one. You are offering a product to a customer. This is your finished product and their raw material. When both parties agree to the terms and conditions (payment, form, fit, function, shipping, etc.) a contract exists. We call this a purchase order (PO) and part of that PO is the specification for your product. If they place an order to your spec, you have done the design work under ISO 9001 and they are accepting your design. END OF YOUR RESPONSIBILITY for future application and use. If you accept an order to their spec, they have done the design work and you are obligated to make sure your product meets the stated (and often implied) form/fit/function requirements. We call this quality control and you do this by testing in the lab prior to shipment.

Most firms address the issue of application by stating quite clearly in the contract terms that you are selling your product as-is and you do not warrant the product as fit for ultimate use. This is the kind of thing the lawyers require.

Having said all this, there is a requirement in ISO 9001 for you to measure customer satisfaction. You must state in your manual the concept (strategies) for doing this and have some defined processes – usually called procedures – to carry it out. Of course, part of this is the regular management review. Quality, marketing, and sales all provide input on how well the customer needs are being met. Your registrar should be examining how you do this.

If there is a trend showing that customers are unhappy with how the stuff performs under end-use conditions, ISO says you should address those issues. (Ignoring them is an option, if it is deliberate). Mature firms will work on building customer-supplier partnerships, getting their engineers to talk to your engineers. Although this is technically outside of the quality function, it is still part of your overall quality management system.

Charlie Cianfrani
Consulting Engineer
Green Lane Quality Management Services
Green Lane, PA
ASQ Fellow; ASQ CQE, CRE, CQA, RABQSA Certified QMS-Auditor (Q3558)
ASQ Quality Press Author
Related Content:

Open access resources about supplier quality and product development:

Two Sides of the Same Coin: Using Teams in Customer-Supplier Relationships, Journal for Quality and Participation

In the Know: A BoK dedicated to quality in outsourcing is essential in today’s global marketplace, Quality Progress

The Role of Quality Management Practice in the Performance of Integrated Supply Chains, Quality Management Journal

Has Information About Quality Become a Liability? Quality Progress

Product Liability: Beyond Loss Control — An Argument for Quality Assurance, Quality Management Journal

ISO 9001 Management Representative and Reporting Structure

 

Q: Please define the preferred method of meeting the requirements of the management representative in regards to clause 5.5.2.b in ISO 9001:2008 Quality management systems–Requirements.

My organization has reorganized, and I find the role of management representative somewhat detached. I work for a military organization that would like this role to be several layers below the base captain vs. the open door policy for the management representative used by previous commands. Should the management representative have direct access to the top?

A: There is no defined or preferred method for addressing the reporting arrangement for the management representative to top management. Your organization defines and deploys the approach that is workable for the management representative to report to top management.

Charlie Cianfrani
Consulting Engineer
Green Lane Quality Management Services
Green Lane, PA
ASQ Fellow; ASQ CQE, CRE, CQA, RABQSA Certified QMS-Auditor (Q3558)
ASQ Quality Press Author

ISO 9001 clause 8.2.3 and 8.4

Q: Our quality management department, of which I am the lead internal auditor, has a question that we have been debating for some time:

How do we apply ISO 9001:2008 Quality Management systems-Requirements, clause 8.2.3 Monitoring and measurement of processes and 8.4 Analysis of data, in a non manufacturing organization?

Our organization is primarily software, software modification of COTS that is implemented into our products, and applications modified for our business unit’s use.

My specific questions are:

1. How is the effectiveness of process improvements measured.

2. What methods of measurement do we use to capture the effectiveness?

3. Is there a check sheet or report form available that would guide us on how to apply these two requirements?

Thank you for your assistance in this matter. We want to implement a methodology for capturing measurement and effectiveness of process improvement data, but are at a loss as to how and where to start.

A: You posed several questions about ISO 9001 compliance.

1. How is the effectiveness of process improvements measured?

In a service environment there are typically many process characteristics that can be monitored or measured to assess whether the process has been planned and is being carried out under controlled conditions. Without knowing details of your service offering, it is difficult to comment explicitly.

Possible examples of metrics that may be appropriate include on time completion of a project, after-release detected “bugs,” time required to maintain “released” software modules, and etc.

Also, such metrics can be graphed and cost can be tied to each metric so that when process improvements are made, the benefits can be presented to management in management review in terms of the financial benefits of aggressive measuring and monitoring initiatives.

2. What methods of measurement do we use to capture the effectiveness?

See #1 above.

3. Is there a check sheet or report form available that would guide us on how to apply these two requirements?

Any check sheet or form would have to be developed by you to suit your processes.

A few references that would be helpful to you are ISO 9001:2008 Explained, Third Edition and How to Audit the Process-Based QMS.

Charlie Cianfrani
Consulting Engineer
Green Lane Quality Management Services
Green Lane, PA
ASQ Fellow; ASQ CQE, CRE, CQA, RABQSA Certified QMS-Auditor (Q3558)
ASQ Quality Press Author

Is ISO 9004:2009 an Implementation Guide?

ISO documentation practices, requirements

Q: I am looking to purchase the latest ISO 9001:2008 Quality management systems–Requirements. However, in the past, ISO 9004:2000 Managing for the sustained success of an organization — A quality management approach,  included the ‘requirements’ of ISO 9001 in boxes as a reference in ISO 9004 (used for implementation assistance). Is that still the case? I would much rather buy the revision, ISO 9004:2009 if the ISO 9001 requirements were in the standard…it’d be one less standard to have around.

A: We have consistently promoted the concept that ISO 9004 is NOT an implementation guide to ISO 9001. It is designed to provide guidance to organizations that desire to go beyond meeting minimum requirements towards achieving higher levels of performance.

There is much that is required of organizations today to sustain themselves and the next edition did try to focus on addressing issues that were essential to sustainability, perhaps at the expense of revisiting the old ground of content related to 9001 compliance which, by now, have become well understood by many organizations.

So, ISO 9004 is about going beyond ISO 9001. ISO 9004 is still consistent with ISO 9001, but it places more intensity on going beyond and less on hard line-by-line congruence.

Charlie Cianfrani
Consulting Engineer
Green Lane Quality Management Services
Green Lane, PA
ASQ Fellow; ASQ CQE, CRE, CQA, RABQSA Certified QMS-Auditor (Q3558)
ASQ Quality Press Author