Category: Other

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.

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.

Audit Versus Inspection?

Audit, audit by exception

Question

Would you please tell me what the differences between audit and inspection are?

Answer

This is a great question.   We can start with the definitions of inspection and audit per the new ISO 9000:2015 standard.  Inspection is “Determination of conformity to specified requirements”  (3.11.7)  and Audit is “systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled”  (3.13.1).

Without parsing the words to much, the difference is one of scale:  Inspection is most often associated with inspecting a product or a service to make sure it is right, and an audit is most often associated with a higher-level review of the system that is designed to produce and inspect the product or service.

An audit of a manufacturing process wouldn’t just inspect the product, it would ensure (at a system level) that required inspections had already been performed on the product.  I have often made the differentiation in the following way… “An inspection is down in the grass, but to do an audit, you have to climb a tree.”  The reflects the difference in purpose and perspective for an audit.   Other authors, such as Arter, Sayle, and Russell refer to inspections as ‘backward looking’, that is, what was actually done to provide a product or service, while audits are ‘forward looking’.   Audits ensure that proper management controls are in place to ensure product quality into the future.   Instead of inspecting quality in (to a product produced in the past), an audit evaluates how well a quality system will predict and prevent quality problems (in the future).   My three favourite references are Quality Audits for Improved Performance by Dennis Arter, Management Audits, by Allan Sayle, and the ASQ Auditing Handbook, edited by JP Russell.

Thanks very much,

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

Transitioning to ISO 9001: 2015

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

Question

ISO 9001: 2015 has a 3 year implementation period. I recertified in 2014 and need to recertify in 2017. At this point I have a little under one year to transition instead of the 3 years identified. What alternatives are there that I might take advantage of so I have a longer transition period? My 3rd party registrar has been no help.

Answer

I would suggest that this individual approach their registrar/auditor and reason with them. I have heard of 3rd party auditors who are willing to help organizations with their transitions in numerous ways, including finding a comfortable way to transition without losing investment made in the current standard.

Second, the requirement to transition over to the new standard is not demanding that people wait until their current certificate runs out.  This company can begin a gradual transition right away. Stretching it over a couple years gives a company plenty of time to ‘learn’ and transition. Therefore, 2017 would be a possible time for a smooth change over to the new standard.

Registrars are our helpers; not some strangers lurking in the dark. They should be approachable and willing to help.

Also ASQ, as well as other sources, offer various forms of transition training and information.  The new standard can seem a bit intimidating at first glance but once thoroughly examined, it is actually more simple in several areas.

Atychiphobia – a persistent fear of failure can lead us to see stumbling blocks ahead of us. You can turn those stumbling blocks into stepping stones with some support from your registrar and a positive attitude.

Bud Salsbury, CQT, CQI

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

Switching Rules

Manufacturing, inspection, exclusions

Question 

We are planning to implement ANSI/ASQ Z1.4-2003(R2013) sampling inspection plan with our Finish products which are currently 100% inspected by QC Inspectors.  I read  about the importance of the switching rules  on a continuing stream of lots and have the following  questions:
1.Is it acceptable to select a specific plan (tightened, normal or reduced ) and use it without the switching rules?
2.Are there any exceptions which allow us to use a specific plan without applying  the switching rules?

Answer

  1. You can use any plan without using the switching rules but it does run the risk of not meeting the alpha risk in the end. These plans were developed to be used as documented. A normal plan is generally used and the switching rules come in when the clearance number has been obtained.  Some processes may never switch.  If you choose a plan that is tightened or reduced to start with, you potentially will either spend too much on inspection (tightened) or risk having bad product go to the customer (reduced).  It is a business decision for you to make if your customer is not demanding it.  The switching rules are there to protect the producer when the product is running very well or it has problems.
  2. If your customer is not requiring a particular plan, you can use what you want. It is a business decision, no reason for any exceptions.

I hope this helps.

Jim Bossert
Sr Performance Improvement Specialist
JPS Hospital
ASQ Fellow, CQE, CQA, CMQ/OE, CSSBB, CSSMBB
Fort Worth, TX

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

ISO 9001:2015 Documented Information Requirements

ISO documentation practices, requirements

Question

I am trying to ascertain if I need to write a Quality Manual to comply with ISO 9001:2015. I see some clauses require ‘documented information’. Do I just address those or the entire document?

Answer

Thank you for the question.

To begin with, the new ISO 9001:2015 standard does not present a requirement for a Quality Manual. Those requirements are now part of Clause 4.3 and 4.4 of the new standard. That information “shall” be maintained as documented information.

You would be wise to 1] Acquire a copy of the 9001:2015 standard if you haven’t already done so. 2] Check in ASQ.org for information explaining the new terminology related to the standard. 3] Consider pursuing the services of a quality consultant for thorough guidance.

Respectfully,

Bud Salsbury
ASQ Senior Member, CQT, CQI

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

Value Stream Mapping

Certification, ISO 9001

Question

We produce plastic fittings and pipes. We only have one process: only one machine is needed to produce a product.  Can we still benefit from Value Stream Mapping? If yes, could you please explain how?

Answer

Thank you for your question.  Value Stream Mapping (VSM) can benefit organizations of any size.  The fundamental question you want to answer is: How quickly can I receive an order, build it, and be paid for it?    This is “order-to-cash”.  Along the way, we look primarily at two things – how quickly and smoothly can I get a build order to flow through my factory, and how do I minimize raw material inventory and work-in-process inventory during that process?

Value stream mapping can benefit your organization by answering some of the following questions…. How long do I wait for raw material (e.g., am I buying from down the street, or does it take months to arrive from China)?  How long is a customer order in hand before I start up my machines to produce it? How long is my machine set-up?  How long does work in process sit between machines?  How long does material sit in the back of the plant before it is shipped?   How long does it take me to get paid?    Value stream mapping can help to answer these questions and challenge your organization to continuously shrink these times.     I had one client who got very good at this.  They insisted on payment from key customers within 30 days, and had payments terms of 60 days with their suppliers.    In many cases, they were paid for their products before they even had to pay for their raw materials.  That’s lean!

Denis.

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
www.DevosAssociates.com

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

Dual Certifications

Drill, oil, petroleum

Question

Our company currently holds dual certifications to API Q1 and ISO 9001:2008 that are not set to expire until November 2017. When making the transition to ISO 9001:2015 and re-certifying in November 2017, will we be able to do dual certifications or will we have to do API Q1 separate from ISO 9001:2015?

Answer

Hello,

Thank you for contacting ASQ’s Ask the Experts program.  In response to your inquiry, the timing for transitioning your existing QMS from ISO 9001:2008 to ISO 9001:2015 is dependent upon your Registrar’s timeline to begin issuing ISO 9001:2015 certifications.  I highly recommend that you discuss this subject with your Registrar to determine how and when this transition will take place.  In my professional opinion, this transition process may be similar to the recent move from API Q1, 8th edition to API Q1, 9th edition.

Since your current certification expires November 2017, transitioning sooner rather than later is recommended.  Especially since unlike API Q1, the ISO 9001 certification expiration date cannot be extended.

I hope this helps.

Best regards,

Bill

Bill Aston, Managing Director
Aston Technical Consulting Services, LLC
800 Rockmead, Suite 170, Kingwood, TX 77339
Office: (281) 359-2827
Website: www.astontechconsult.com

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