QUALITY REVIEW January

2011
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A Newsletter for Quality Management Professionals

The Business Resource Centre

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Email: info@thebrc.ca Web Site: www.thebrc.ca

HTUUU UTH HTU UT

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Hours: Monday to Friday 8:00 am to 5:00 pm

Introducing…
Peter and Elizabeth Annis are both pleased and proud to announce the
addition of their son, Ted Annis, to the business this year as Director of Sales
& Marketing. Since graduating from Princeton University in 1997, Ted’s
professional experience includes Director of Sales & Marketing for a leading
consumer electronics company and several years as the Director at Princeton
Sports Center, a multi-sport recreational facility in New Jersey. He has been
working as a consultant for The BRC for the past 9 months, is a Certified
Lead Auditor, and has the knowledge and experience to continue The BRC’s
tradition of quality service and customer care.

Over the next several months, The BRC will be working hard to expand our
course offerings and incorporate new technology to provide more niche
training in a convenient format.
Ted Annis
Director, Sales & Marketing Peter, Elizabeth and Ted are looking forward to an exciting 2011!

“Delegation is never abdication. Rather, it’s learning to work ON the business instead of
IN the business. Good leaders know when to get out of their own way.”
- Ray Silverstein
Author: Small Business Survival Guide: How to Survive (and Thrive) in Tough Times

Root Cause Analysis – Problem Understanding

Part 2: Understanding the GAP
By Ernie Payette, BA, Med, BRC Senior Consultant

In the previous article of this series, Part 1: Connection to Work Processes, in the October 2010 issue of our
newsletter, the connection between problems, work processes, and eventual solutions was introduced. Lack of
achievement of goals and/or key performance indicators results from a breakdown or failure somewhere in a work
process. Consequently, there is a discrepancy between what should have been (the requirement) and what actually
occurred (the result or product). This discrepancy we described as a “gap” between the current condition and the required
expectation. As noted in Part 1, it is in our understanding of this ‘gap’ where a more realistic and comprehensive
understanding of all aspects. .

It is important to remember that the ‘gap’ may be considered to exist within a process, to impact on the desired attributes
of a product/service, or to reside as latent issues within the organization as a whole. .
 Expected Performance
0B

Understanding the Gap

1B

• Concern
• Requirement
• Evidence Problem Solving
PROCESS GAP Root Cause
• Impact
Activity

Actual Performance

To understand and to be able to effectively communicate the elements of the gap so as to determine the causal agents
responsible for the deviation or undesirable event, use of the following four descriptors is often helpful: concern,
requirement, evidence, and impact.

Concern: To clearly understand both the nature and magnitude of the problem, it is important to be able to describe what
is wrong. This may show itself as a symptom (effect) or as a failure condition (failure mode). Equally important is being
able to describe ‘what is different from what should be’.

Remember, at this stage in the process or investigation you are focusing on ‘what is wrong’, not ‘what caused the
problem’ or ‘why’. Anytime you ask the question, “What is the problem?” you will generally get disagreement from
different members of the team. This is not unusual. In fact, it is quite normal. We all see things from different points of
view and our own perspective. The challenge here is to not get hung up on the ‘what’. Accept different points of view,
record them and move on. Narrowing down and or sorting will occur in the ‘Analysis Phase’.

Two other of the infamous 5 W’s…when and where…are dealt with as we attend to the ‘concern’ category. The ‘when’
question captures information related to date and time, and may include a “time-line” associated with the specific chain of
events that makes up the process. The “where” question seeks to provide information to determine both where the event
physically occurred (location) and where the event happened in the actual work process.

Lastly, information describing what is different should be identified. Anything that sticks out as being different from normal
operations or appears to have changed should be noted. However, it is during the Analysis Phase where you will
determine if any differences were in effect causally related to the deviation or undesirable event.

Requirements: Obviously, to be able to determine what is different from what actually occurred versus what should be,
we must refer to the actual ‘requirement’. The ability to reference where the requirement can be found is imperative.
Descriptions here should be stated as defined in the organization’s “Requirement Document” using the language of the
organization. This information can be found in procedures, policies, drawings, specifications, etc. Interestingly enough,
one of the major reasons problems are not effectively solved is that the “requirement” is not clearly known or defined.

Evidence: Any statements that indicate the requirement is not being fulfilled according to specifications must be
supported by ‘evidence’. Your starting point will generally be determined from data initially gathered in immediate
response to the problem. Other objective evidence, usually historical, collected while monitoring or auditing the process
should also be considered. Information and/or tangible evidence gathered must be verifiable. If not, it must be clearly
identified as “speculative”. Make No Assumptions!

Impact: Last, but by no means least, is a determination of the effect of the problem/undesirable event on organizational
goals. The starting point for every problem investigation is the negative impact on the overall goals of the organization.
At this stage, quantifying the impact on the organization may be extremely difficult. However, even if many of the answers
are based upon subjective evidence, answers to the following questions should be addressed.

 Is the customer affected?  How much does it cost?  What is its ‘Growth Potential’?
 How big is the problem?  What is its ‘Urgency’?

In the next article we will begin to explore the Analysis Phase which focuses on the question “Why did it happen?” There
is a tendency by many who are required to do investigations to want to start here. Don’t! It is imperative that time be
taken to adequately address the ‘Problem Understanding Phase’ before moving forward. .

You are welcome to request a copy of PART ONE of this series on Root Cause Analysis from our October 2010 Quality Review
Newsletter.

Watch for PART THREE to come in a future issue!

 The Ten Steps to Conduct a PFMEA
(Process Failure Mode Effects Analysis )

1: Review the process

2: Brainstorm potential failure modes
3: List potential effects of failure
4: Assign Severity rankings
5: Assign Occurrence rankings
6: Assign Detection rankings
7: Calculate the RPN (Risk Priority Number)
8: Develop the Action Plan
9: Take action
10: Calculate the resulting RPN

For the full article explaining each of the ten steps in detail, please request a complimentary copy from
our office.

Integrated Auditing – The Need and the Challenge

By Mike Haycock, Sr. BRC Associate

While it would seem that integrated auditing is a “natural’, it has not been. The biggest difficulty has been that the Quality
(9001), Environment (14001) and Health and Safety (18001) “management systems” have not been integrated within the
organization to begin with. For most organizations…and I mean most…having a single management system, usually
Quality (9001), has been as much as has been attempted. Environmental requirements and Health and Safety are
typically dealt with because there are government statutes and regulations that have to be addressed.

Environmental systems (ISO 14001) have been implemented much less frequently and even fewer Health and Safety
systems (ISO 18001) have also been put in place. When they are done, they are usually done as stand alone systems
based on a particular champion or specific mandate. The ISO 9001/14001/18001 systems are voluntary, meaning the
organization chooses to adopt these systems. (The reason that the preponderance of Management systems are based on
Quality (ISO 9001) is because your customer has helped you make your choice, as a prerequisite for doing business.
There has been little comparable expectation for ISO 14001 and ISO 18001, although some automotive customers had an
expectation for ISO 14001.)

Having said this, I think that integrated auditing can be valuable in adding overall effectiveness and efficiency in the way
any organization operates. We can audit anything that has been implemented and integrated without much difficulty. The
challenge is auditing systems which, even if they reside in the organization as previously stated, are typically in place as
stand alone and not integrated. Let’s look at the situations where much has been done and little has been done. My
suggestions follow.

We have two typical situations when directed to conduct integrated audits. In both cases there is a very specific
need to understand the systems being audited. That means that if auditing Quality (9K), Environment (14K), and Health
and safety (18K), or some combination, there is a very clear and specific need to know and understand these standards.
There is also a very clear and specific need to be qualified as an auditor but this can come through training covering the
Auditing standard, ISO 19011, which is essentially the same for all.

First situation: the organization has implemented a fully integrated system. This is clearly the best situation and the one
that is most commonly missing. If the system owner(s) have implemented the system this would mean that the
implementation process has identified the linkages with each standard, and requirement, where they are common, where
they stand alone, and a schedule would be developed to cover the required activities. With a fully implemented system
and with the proper training, this would not be difficult. (I know - and if snow were gold most of us would be rich.) In almost
20 years I can remember only “2” organizations where the three ISO systems were fully and effectively implemented and
subsequently were able to be audited with some sense of control. I’m sure that there are more by now – just not a lot
more.

Second situation: is most common where there is a system in place. Most commonly this is Quality (ISO 9001 or the
industry equivalent) and there is intent to include or add the Environment or Health and Safety or both or some portions of
these standards. (I know "or" is used a lot and that’s our challenge.) There is also the situation where the organization has
multiple management systems in place, which are not integrated but which the organization would like to have audited at
the same time……which is integrated auditing for a non-integrated system. Some of you do supplier audits and I
would use the same method, but being selective about the portions of systems and requirements included.

I’d like to set out a brief methodology that I use when I’m teaching. I cannot cover it all, because it’s typically done in three
days, but I can give you a brief overview.

First, on a board or flip chart, I start with a foundation – and that is Quality ISO 9001. This lays out a system which can be
adapted to any organization. I have never found any organization for which this could not be adapted. (I was once even
approached by the minister of a church (story is too long) and while the conversation was more friendly than serious, I
was certain it could have been adapted. Anyway, all requirements of the standard have to be reviewed. I develop a high
level process map for the organization, with core activities, management activities and support activities and then link the
Quality standard requirements to the high level processes.

I would then take the Environmental management system, ISO 14001 and review all these requirements in order to have
a clear understanding of what they are, as well as the intent of the requirement. I would then take the requirements of ISO
14001 and add to the Quality process map where applicable. For example, I would include Environmental policy
statement 4.2, with the Quality policy statement 5.3. These would be natural to be audited at the same time. Management
review 4.6, in ISO 14001, would be included with Management review in ISO 9001, 5.6. I would go through and match up
everything where possible. BUT, some requirements will not match up. ISO 14001, 4.3.2 Aspects and Impacts has
nothing comparable in Quality. And that’s OK, but if you try to match where it doesn’t make sense, it will only be
confusing.

I would then take the Health and Safety system ISO 18001 and review. I can’t stress this enough! You cannot possibly
believe that if you and your team do a couple of audits a year, you can just pick up your new audit cycle without some sort
of review. The good news for ISO 18001, is that the requirement numbers match “almost” one for one with ISO 14001.
That does not mean they can be absolutely integrated, but it is very helpful.

ISO 18001- 4.3.2, is Hazard and Risk. While this is comparable to ISO 14001- 4.3.2, Aspect and Impact you would almost
certainly NOT audit at the same time because in most organizations the people responsible for Environment are not the
same as responsible for Health and Safety, for these particular requirements. That is just a fact. Different education,
knowledge and skill sets are required for each. But again, we match to the ISO 9001 system where we can. Again, an
ideal requirement for integration is the Health and Safety policy statement, 4.2, with the previously integrated Environment
policy statement 4.2 and Quality policy statement 5.3. The management review for Health and Safety also matches well
with the previously identified Quality and Environment. I would then go through and match where they make sense and
leave them to be audited individually where there is no match or minimal match.

When we’re done, we should have a high level process map for the organization based on ISO 9001, to which we have
now added our Environment and Health and Safety requirements. An audit schedule can now be developed to address all
requirements of the 3 systems identified and assigned to qualified auditors. Because we have linked processes to
requirements, this gives the auditor at least the base questions to be asked for each process or requirement and/or
reviewed against the appropriate documentation and to have questions developed at that time.

In the past, I have conducted supplier audits for a number of organizations. Should you also have the need to audit a
supplier, you would want to be clear about your scope, if you needed to evaluate integrated elements. For a specific
supplier audit, a complete Quality system was expected for the audit. However, I also had specific instruction to focus on
inspection and test activities of the supplier. While there was no expectation of a complete environmental system, there
was concern in a couple areas. For example, how the supplier handled their chemicals. There was a specific area of
Health and Safety that was expected to be covered and included. This was an integrated audit, but for specific purpose
and within a defined scope. This is just an example of how different system requirements could be covered.

As I began this article, I thought it might be like trying to explain how to eat Jell-O. There is no “one right way”. Even a
three year old will figure out the Jell-O problem and usually without a spoon. I was just trying to get around some of the
mess.

I also realize that some of this is probably still confusing. The challenge most of you have faced is auditing a single
system and that in itself has been enough. As you consider “integrated auditing” you may feel this is a challenge for
another time. However, part of “continual improvement” could be to start with simple common areas to integrate and
then to expand from there.

Do we need to be “running”? ALWAYS! When do we need to be “running”? For most of us it always seems like sunrise, so
no time like the present. If there are a number of things we can accomplish at the same time so much the better.
 Public Course Training Schedule
February to June 2011
Email: info@thebrc.ca Web Site: www.thebrc.ca
HTU UTH HTU UT

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