denis devos Archives -

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

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

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

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

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

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

Work Instructions and Audits

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

Question

Regarding ISO 9001: 2008 (or 2015) auditing, I have always been trained that a work instruction when implemented as supporting the QMS can be audited as it is supporting the effectiveness of the QMS. I was recently told by a business owner that not only is that not true, he does not have to show me his work instruction. I would like to reply with a clear technical response. Can anyone share their view on this?

Answers

Thank you for your question. Of course you know you’re right. It sounds like you have a major nonconformance against clause 5.1 on your hands.

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

ISO 9001:2015 clause 7.5.1b states the following :
The organization’s quality management system shall include: documented information determined by the organization as being necessary for the effectiveness of the quality management system/

Documented information includes both procedures and records see appendix A.3 (Documented information).

Since the work instructions are supporting the QMS, it is part part of the QMS, and can be audited as part of both the internal audit and external audit. It appears that part of the confusion may be caused by a lack of understanding of the new term “documented information.”

John G. Surak, PhD
– Providing food safety and quality solutions –
tel: 1-864-506-2190
skype: john.surak
email: jgsurak@yahoo.com
A member of Stratecon International Consultants
http://www.stratecon-intl.com/jsurak.html

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

Verification or Calibration?

Automotive inspection, TS 16949, IATF 16949

Question

There is a second part to 7.6 para “a” which reads; “where no such standards exist, the basis used for calibration or verification shall be recorded.” It is clear for shops that are complying to the ISO 9001: 2008(E) we need to have measurement standards traceable to international or national measurement standards. My question has to do with cylindrical plug gages that are used at the machines to verify manufactured print dimensions. The pins/plug gages are not sent out at intervals for calibration however, they are compared to a traceable measurement standard before being issued to the manufacturing area. We consider these gages to be calibrated “as used ” and we do not record the initial actual size of the pins/plug gage but issue it only on the basis that the size was verified against a traceable measurement standard. Are we required per Para 7.6 to record the actual size of the pins/plug gages?

Answer

Thank you for your question. What you are describing is verifying prior to use, rather than calibration. If the rings or other standards being used to check these plug gauges each day are properly calibrated and traceable to national standards, you are compliant with ISO 9001:2015. If you are registered to AS 9100 or TS 16949, stricter requirements will apply and you may not be meeting those requirements for recording variable results of calibration.

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

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

Clauses 8.4.1 and 8.4.2 in 9001: 2015

Mr. Pareto Head and IT

Question

The insurance company I am temporarily helping on quality is limiting its ISO 9001 certified perimeter to the administration of contracts and claims.
With regard to clauses 8.4.1 and particularly 8.4.2 of ISO 9001:2015, should the other internal entities of the company (.i.e HR, IT, Sales Dept, …) absolutely necessary but outside of the perimeter be considered exactly like external providers – just like a provider of IT, for instance – or should they be considered as internal providers with a limited control of their contribution to the QMS through a simplified SLA? Of course, SLAs will be put in place in order to secure the relationship of these internal entities with the perimeter.

I thank you in advance for your help/interpretation of clauses 8.4.1 and 8.4.2 applied to the case submitted.

Answer

Thank you for your question. Yes, that is an appropriate interpretation, but let me add three comments.

Firstly, recognize that your support functions are captive within your organization and therefore not subject to all of the same conditions that would be imposed on an outside service provider. For example, you can’t stop doing business with them if you are not happy with their service. I like your idea for an SLA – keep it simple, but outline your requirements and expectations for their support services.

Secondly, use your process approach (clause 4.4) to define the boundaries of your QMS and how those other external departments interface with you. This will be helpful in helping your team and others to understand the relationship between your QMS and the rest of the organization.

Thirdly, take advantage of the Context of the Organization analysis (clause 4.1) to further explore those relationships and that will help to determine the level of control you require over those support functions.

Denis 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.

“Shall Be Determined” in 9001

Certification, ISO 9001

Question

Many of the Quality Management Systems requirements in the ISO 9001: 2015 standard include the verbiage “shall be determined.” I need to be sure that I understand exactly what this means in this context. For example, “4.4 QMS and its processes 4.4.1 a) The inputs required and the outputs expected of the QMS processes are determined.” Does this mean that there should be process or work instruction written describing this? Does it mean that there should be documentation showing the development of this information?

Answer

Thank you for your question. It might be useful to look at the definition of the word determine. According to the Oxford Dictionary: Determine means to “Ascertain or establish exactly be research or calculation”, Merriam Webster has a similar definition: “to find out about or come to a conclusion about by investigation, reasoning, or calculation.

Now to your question. There does not need to be a procedure about how things are determined. The output, or the determination itself, will serve as evidence that you did it. But determine things in an honest way. You and your CB auditor will assess the reasonableness of your determinations based on the context of your organization. For example, if you are a hospital, and you “determine” that surgeons do not need to wash their hands, you should be subject to a nonconformance for getting that wrong. In your example, taken from clause 4.4, the best way to do this is to create a flowchart(s) showing a series of process steps and their interactions. The arrows in and out of each box along with explanatory text, will demonstrate that you have determined the inputs and outputs of each process step.

Denis 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.

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.

Creating a Culture of Quality

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:

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.

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.)

If the company has a bonus program, individuals/departments bonus is tied into quality performance. ISO observation means 10% or more cut in bonus.

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.

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