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.

Clauses vs. Elements in ISO Standards

Training, completed training, competance

Question

What, if any, is the difference between the words “clause” and “element” in ISO standards?
Specifically, “customer shall conduct an internal audit addressing all elements of the management system.”  And, at what level is this in the standard, eg, 4 or 4.1 or 4.2.1

Answer

1) The difference between the words “clause” and “element” in ISO standards? – No difference.

2) “Customer shall conduct an internal audit addressing all elements of the management system”. –  Customers do not perform internal audits on suppliers.  If this person means that  customer requires a full QMS audit, so does the standard.  “All elements” probably means all QMS processes.

3) At what level is this in the standard, eg, 4 or 4.1 or 4.2.1 – 4 is the clause/element; 4.1.& 4.2 are “sub-clauses”

George Hummel
Voting member of the U.S. TAG to ISO/TC 176 – Quality Management and Quality Assurance
Managing Partner
Global Certification-USA
http://www.globalcert-usa.com/
Dayton, OH

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.

Six Sigma Statistical Meaning

Reporting, best practices, non-compliance reporting

Question

I need to understand the statement, “Adding a 1.5 sigma shift in the mean results …….”
I’m used to the bell curve and + /- three sigma.
How does the extra +/- three sigma fit in, and what is this about moving the mean?
Does ASQ have a good book that includes this detail in with basic statistics?

Answer

The idea of 6-sigma leading to a process with 3.4 parts per million defective is not a totally statistical statement.  Using the normal distribution, we know that a process that is centered on its mean will have 0.135% of the distribution outside 3 standard deviations on each tail.  That same process would have 0.00000010% outside of 6 sigma, which does not lead to the aforementioned 3.4 million parts per million outside.  Dr. Mikal Harry in 1992 published a book (see chapter 6) entitled Six Sigma Producibility Analysis and Process Characterization, written by Mikel J. Harry and J. Ronald Lawson. In it is one of the only tables showing the standard normal distribution table out to a z value of 6.  Here is where he stated that processes can shift by 1.5 sigma leading to only having 4.5 sigma limits and the 3.4 parts per million outside the “6-sigma” limits.  I would suggest you look at ASQ’s Six Sigma Forum Division that will help to better explain the rationale for the shift.

Steven Walfish
Secretary, U.S. TAG to ISO/TC 69
ASQ CQE
Principal Statistician
http://statisticaloutsourcingservices.com

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

ISO 9001 Certification and Moving

Certification, ISO 9001

Question 

My small company is considering ISO certification because some of our customers are asking for it. My concern is that if we continue growing at our current rate, we may be moving in 12-18 months. Is ISO certification site specific – i.e. if we obtain certification and then move, do we need to undergo a whole new certification?

Answer

After the certification audit your company will get a certificate for three years, and you will be adhered to a surveillance audit each year during the mentioned duration. There is no problem in moving if your moving did not lead to changes in your processes, activities, services or products which were included in your Quality Management System’s scope during the first certification audit, but it was just moving to another address. 

Ibrahim Moussa
Founder and Managing Director, at VOICE OF QUALITY for Training and Consulting Services
ibrahim@voiceofquality-eg.com

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

Creating a Culture of Quality

ASQ Global State of Quality 2016

Question

I was introduced to Quality Management (& ISO 9001:2015) recently. The culture of the organization that I am concerned with has not embraced Quality Management, and it is often the subject of outright and unprofessional antagonism. I seek direction in order to arm myself with greater knowledge or qualifications as well as change attitudes toward Quality Management at all levels within the organization. I thought that ASQ would be a good resource. Since there are so many channels, a plethora of literature, and various certifications and conferences, I am a bit overwhelmed. I need to focus my efforts, and I hope to be able to do so with some direction from a professional who can relate to such growing pains. Thank you.

Answer 1

Thank you for your question.  I can certainly to relate to you and your plight – I was in a similar circumstance early in my career.   If you were introduced to ISO 9001 this year, I have to assume that your company is not yet registered.   Most manufacturing companies are required by their customers to have registration, but if you are not in that situation, you have to sell Quality Management on its own merit.  The bad news is, that if your senior management doesn’t want a Quality Management System, there is nothing you can do about that.  Now, that being said, you can begin by examining some of the “pain points” in your organization and showing how quality tools can help to solve them.  Management will never embrace quality until they see what is in it for them.   You can start with an analysis of the Cost of Poor Quality.  When your leadership sees the cost of nonconformance, they will be keen to bring those costs down.  COPQ typically includes the cost of external customer complaints, replacing products, late deliveries, and internal costs such as scrap, rework, re-makes etc.  If there has ever been a problem that traces back to not properly understanding a customer’s needs, that is a text-book example of how Quality Management can help.  Start with that.   Look at the costs of poor quality, and sell the idea of using quality tools to bring those costs down.  You will have no chance of selling your management on quality until they can see what’s in it for them.  Good Luck!

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

Answer 2

It sounds like this company needs a culture change. This change can happen only at the direction of the company’s leadership.
Here’s some suggestions:

  1. Each department head has to establish three (3) measurable goals on how his/her department is improving on the quality of their department’s output/work.  These are to be reported at each executive monthly meeting.  Department manager’s must be held accountable for lack of quality improvements.
  1. Every individual’s performance review must include “quality performance.”  This also needs to be measurable (less than last year, improved customer satisfaction from surveys, reduced ‘cost-of-quality’, reduced audit nonconformance observations, etc.)
  1. If the company has a bonus program, individuals/departments bonus is tied into quality performance.  ISO observation means 10% or more cut in bonus.
  1. Have top executives hold meetings on the need for quality and it’s everyone’s responsibility – not just the QA department.  If employees don’t like it they are welcomed to find employment elsewhere.

Jim

Jim Werner
Voting member to the U.S. TAG to ISO TC 176 Quality Management and Quality Assurance
Medical Device Quality Compliance (MDQC), LLC.
ASQ Senior Member
ASQ CQE, CQA, RABQSA Lead QMS Assessor

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

Acceptance Sampling Inspection

Automotive inspection, TS 16949, IATF 16949

Question

We have an acceptance sampling inspection in place where we use the ANSI/ASQ Z1.4 -2013 standard under Normal Inspection, using General Inspection Level II to drive our samples size and accept, reject criteria. We do not uses switching rules as we have always found them too difficult to manage. I have two questions.

If I have one lot that fails acceptance sampling and I am trying to bound the issue is it suitable to bound it to the one affected lot if the lot before and after pass or do I need to carry out additional sampling.

My second question is if I have a batch that passes acceptance sampling but at a subsequent downstream process a defect being inspected for by the upstream acceptance sampling inspection is found how do I determine if the lot is acceptable? Do I trust the acceptance sampling inspection or react?

Answer

The first question is not an uncommon one and actually it is a good practice to isolate the lot and do 100% inspection of it.  That way you can estimate the % defective and if another failure occurs in the next 5 lots, then increase the sampling until you have some confidence that the supplier has fixed the problem.  Once that confidence is restored, then you go back to what you inspected originally.

The second question, is one that you have to understand how well do you follow the acceptance sampling process?  If your alpha level is at 95%, 5% of the time, you can accept a bad batch as good. That is the pure definition of the alpha risk.  If this failure falls within the 5%, your process is working and while you sort through the lot, and notify the supplier, it is not something that you over react to.

I hope this helps.

Jim

James Bossert, PhD, MBB, CQA, CQE, CqM/OE
Sr Performance Improvement Consultant

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

Charging Lab Fees

Calipers, Measuring, Measurement, Accreditation, ISO 17025

Question

We are in the process of getting our new laboratory ISO 17025 certified. At this moment, our lab is a part of a parent organization. However, it has been requested that the lab should have its own name and with the ability to charge fees, etc. My question is would that be possible without establishing the lab as its own company (LLC, division, etc.)? If we charge fees, would we be considered a third party lab in relation to our parent company with our own, HR, admins, IT, etc separate from the parent company?

Answer

The ISO/IEC 17025 accreditation (not certification) process allows for captive laboratory under a parent organization to become accredited. ISO/IEC 17025:2005 Clause 4.1.4 states:

If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.

 NOTE 1 Where a laboratory is part of a larger organization, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory’s compliance with the requirements of this International Standard.

 NOTE 2 If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgement. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgement and integrity in relation to its testing or calibration activities.”

There is no requirement that the “laboratory should have its own name and have ability to charge fees”. It is up to the laboratory to organize in a manner that it sees fit as long potential conflicts with the parent organization are identified. Notes 1 and 2 provide more guidance for this Clause. Nor is there a requirement that it have its own IT, HR and other departments as long as those arrangements are identified and any potential conflict of interest resolved to the Accrediting Body’s interest.

Dilip A. Shah
ASQ Fellow, ASQ-CQE, CQA, CCT,
President, E = mc3 Solutions,
Technical Director, Sapphire Proficiency Testing Services
Chair, ASQ Measurement Quality Division (2016, 2012-2013, 2007, 2004-2005)
Past Member of the A2LA Board of Directors (2006-2014)
Tel: 330-328-4400
Fax: 1-888-226-9533
E-mail: emc3solu@aol.com

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

Internal Audits and Third Party Audits

Analysis, Statistics, Control Charts, Statistical Methods, Audit, Auditing

Question

Shouldn’t a company audit its own processes and procedures to ensure compliance before a third-party audit is scheduled?

Answer

Thanks for contacting ASQ’s Ask the Experts Program.  In response to your inquiry, yes, it would be a good idea for the organization to conduct an internal audit before a third party audit is performed, especially if no previous internal audit has been completed.  It’s important to remember that the primary purpose of conducting an internal audit is to assess the continued implementation and effectiveness of the quality management system and its processes.  Not conducting internal audits on a scheduled basis could jeopardize the organization’s ability to maintain its ISO 9001 certification as well as increase the probability of the occurrence of nonconformances and customer complaints.  An internal audit process is an indispensable tool required for the assessment of the QMS, its processes as well as to identify opportunities for improvement.

I hope this helps.

Best regards,

Bill

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
Website: www.astontechconsult.com

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

Unsigned Audit Report

ISO documentation practices, requirements

Question

Is it acceptable for an auditor to submit an UNSIGNED audit report in Word version? I’m QA director at a pharmaceutical CRO. We were recently audited by one of our clients. They refuse to provide a signed audit report because they say it is not their policy to do so. This seems wrong to me on many levels. Is this acceptable?

Answer

Thank you for submitting this question to ASQ’s Ask the Experts Program.

I’m not aware of any requirement that states that the auditor must sign the audit report. In situations, where an audit organization is involved, the audit organization’s management or representative signs the audit report cover letter. The name of the lead or principal auditor, as well as the names of all audit team members, should be included in the audit report. The actual audit report may or may not include a signature sign-off from the auditor or audit team members.

If an audit organization is not involved, then it would be the responsibility of the lead or principal auditor to sign the cover letter or audit report to approve its content. As you’re aware, the audit report serves as a record to document the audit results. For this reason, the signature of the auditor or audit organization is essential since it confirms the content of the audit report. This sign-off may appear on the cover letter or the report.

If your organization requires sign-off on the audit report in addition to the cover letter, then this requirement should be identified and agreed upon by all parties prior to conducting the audit. In the future, if no audit organization is involved, consider requiring independent auditors to provide copies of their qualifications and auditor certifications (ASQ CQA, Exemplar Global, IRCA, PECB or other) before the start of the audit. Aforementioned could minimize a recurrence of this or a similar concern.

I hope this helps.

Best regards,

Bill

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
Website: www.astontechconsult.com

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