the international edition

60 Pages·2011·4.95 MB·English

UASAR
BARQA MEMBERS MAGAZINE | JANUARY 2012
THE INTERNATIONAL EDITION
No.118 ISSN 1463-1768
FEATURED ARTICLES
Sources of Root Cause
Analysis Failures
Implications from
Complexity Management
for Quality and
Regulatory Affairs
Patient Safety in
Asia-Pacific – A
Regulatory Update
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02Quasar
CONTENTS
07 11 Implications
from Complexity
Management for
This publication is a service offered by Quality and Regulatory
BARQA to its members and BARQA cannot
and does not guarantee that the information Affairs
is complete.
BARQA shall not be responsible for any
errors or omissions contained in this
publication, and reserves the right to make
changes without notice. The information
provided by third parties is provided ‘as is’
Erin Evans
and BARQA assumes no responsibility for
the content.
In no way is BARQA liable for any damages Sources of Root Cause
whatsoever, and in particular BARQA
Analysis Failures Electronic Source
shall not be liable for special, indirect,
consequential, or incidental damages or Documentation in
damages for lost profits, loss of revenue
arising out of any information contained in Clinical Trials
this publication. Mark ParadiEs
Material for publication in
Patient Safety in Asia-Pacific
Quasar
Quasar is published four times a year and – A Regulatory Update
articles can be submitted to Quasar at 17
anytime and should be sent initially to the
Editor/relevant Sub Editor. The final copy lEah navarro-silva, BlakE JEnsEn
deadlines are as follows: ZolkiFli Bin MohaMEd
Final copy Publication said, Tong shi Ping
deadline date
An Australian
February 20th 2012 April 1st 2012 14 Perspective:
May 21st 2012 July 1st 2012
August 20th 2012 October 1st 2012 Regulation of Dietary
November 19th 2012 January 1st 2013
Supplements,

Whilst every effort is made to produce and
Functional Foods
distribute Quasar as early in the month
as possible, no guarantee can be given and Complementary
to publish on the first day of the month.
Medicines
20
WEndy FrEE
REGULARS
04 Editor’s Comment 28 2011 Annual Conference 51 Outreach Working Party
05 Chairman’s Message 30 Committee News 52 Medical Devices
06 Board Biography 30 Good Clinical Practice Working Party
35 Good Laboratory
- Michael Bean 54 Regional Forums
Practice
23 Distance Learning with 39 Animal Health 58 Board & Committees
BARQA 40 Good Manufacturing
60 Diary Dates
Practice
24 EQAC Update
42 Good Pharmacovigilance
25 Hi Society - SARQA Practice
46 Computing
26 V iewpoint - George A. Karam
49 Education and Training
27 BARQA Award
50 Publications
FEATURED ARTICLES
07 Sources of Root Cause 14 Patient Safety in 20 An Australian
Analysis Failures Asia-Pacific – A Perspective: Regulation
Regulatory Update of Dietary Supplements,
11 Implications from
Functional Foods
Complexity Management 17 Electronic Source
and Complementary
for Quality and Documentation in
Medicines
Regulatory Affairs Clinical Trials
JAN ‘12 Quasar03
EDITOR’S COMMENT
viCToria sTaCE
Happy New Year! In addition to these articles, there are
some non themed articles: one on
After the successful International Edition
Distance Learning with BARQA and one
of Quasar in January 2010, two years
located on the BARQA website – Jan
on, the theme has been repeated with a
Robinson’s article titled ‘What’s the Real
number of articles from around the globe:
Value of Audit? Results of the ‘QA: Friend
USA or Foe’ Survey’.
Mark Paradies’ article on ‘Sources of Topically, for this edition:
Root Cause Analysis Failures’ discusses
Hi Society features the Swedish
four sources of failures and concludes
Association of Research Quality
with four action items to improve your
Assurance (SARQA) and details the
company’s process.
Memorandum of Understanding
Blake Jensen reviews the 2010 FDA draft
signed at the BARQA Annual
guidance in his article ‘Electronic Source
Conference
Documentation in Clinical Trials’.
An overview of the European Quality
Australia Assurance Confederation (EQAC) is
Erin Evans’ article on ‘Implications from featured on page 24
Complexity Management for Quality
Viewpoint features George A. Karam
and Regulatory Affairs’ details some of
from the USA with his view on the
the main issues from the origins and
Outsourcing process.
presents some of the key insights for
quality and regulatory managers. Also in this edition, Michael Bean’s
board biography and updates from
Wendy Free’s article titled ‘An Australian
the 2011 Annual Conference including
Perspective: Regulation of Dietary
the recipients of the BARQA award for
Supplements, Functional Foods and
extended, outstanding service to the
Complementary Medicines’ gives an
Association. The committee and working
overview of those products which make a
party updates, this time includes a
therapeutic claim.
new Publications Committee update,
Asia-Pacific see page 50. The regional forum pages
includes updates from the North of
Leah Navarro-Silva, Zolkifli Bin Mohamed
England, Australasia, the new BARQA
Said and Tong Shi Ping’s article ‘Patient
regional forum in India and dates of
Safety in Asia-Pacific – A Regulatory
upcoming forums in other regions.
Update’ describes the safety reporting
requirements of some of the regulatory
agencies in the Asia-Pacific region.
CONTACTS
PUBliCaTions
sUB EdiTors CoMMiTTEE sECrETary
CoMMiTTEE ChairMan
Sarah Howard Good Laboratory Practice Committee Animal Health and Pharmacovigilance Claire van Leersum
and Regulations: Committees and Regulations:
Paula Allen Jon Read
EdiTor
Computing Committee and Regulations: Working Party Updates:
Board Biography and Editor’s Jan Ball Trev Simmons
Comments:
Victoria Stace Viewpoint and Hi Society features: Education and Training Committee: BarQa oFFiCE
Andrew King Daniëlle Willekens
British Association of Research
EdiTorial adMinisTraTors Good Clinical Practice Committee and Good Manufacturing Practice Committee Quality Assurance
Regulations: and Regulations and Regional Forums: 3 Wherry Lane Ipswich
Updates, Diary Dates, BARQA Mary O’Flaherty Sara Yeats Suffolk IP4 1LG
Information and Advertising:
Danielle Stafford T: [phone]
BARQA Office F: [phone]
Tony Ward Email: [email protected]
BARQA Office For Contact Details see page 59

0044QQuuaassaarr JJAANN ‘‘1122
Chairman’s
Message
raChEl hodgEs
Dear Friends,
By the time you read this edition of Quasar, Christmas will have
been and gone and we will hopefully all feel fully refreshed
following the break.
The last few months of 2011 were very busy for BARQA and I
would like to share a few highlights with you here:
Conferences
The BARQA Annual Conference held in Bristol in September was
superb, with an extensive programme, and you will find further Guidelines for auditing management
details on page 28.
systems ISO 19011 revised
During the conference, the Annual General Meeting (AGM) of
the Association was held and along with the routine agenda of In November 2011, ISO 19011:2002 “Guidelines on quality and/or
the AGM (accepting the minutes of the 2010 AGM, passing the environmental management systems auditing” was replaced by
ordinary resolutions to receive the annual report and accounts ISO 19011:2011 “Guidelines for auditing management systems”.
for year ended 30th April 2011 and reappointing PKF (UK) LLP as
The main changes to the guidance are:
auditors) the following people were thanked for their support and
the scope has been broadened from the auditing of quality
commitment to the Association as they retired from the Board:
and environmental management systems to the auditing of
Andrew Waddell as Past Chairman
any management systems;
Harjit Lall as Ordinary Board Member
D erek Murphy as Ordinary Board Member and Chairman of remote audit methods and the concept of risk have been
the GMP Committee introduced;
The following people were welcomed onto the Board as they filled confidentiality has been added as a new principle;
three vacancies:
Clauses 5 (Managing an audit programme), 6 (Performing an
Louise Handy for the post of Chairman Elect
audit) and 7 (Competence and evaluation of auditors) have
S ven Buckingham for the post of Ordinary Board Member and
been reorganised
Chairman of the Animal Health committee
M ichael Bean for the post of Ordinary Board Member and additional information has been added to a new Annex B
Chairman of the Pharmacovigilance committee (Additional guidance for auditors for planning and conducting
A further three other vacancies on the Board received no audits), resulting in the removal of help boxes;
nominations at the time of the AGM but have since been filled by the competence determination and evaluation process has
co-option: been strengthened;
S ue Anderton for the post of Ordinary Board Member, with the
illustrative examples of discipline-specific knowledge and
portfolio of Regional Forum
skills have been included in a new Annex A.
D avid Butler for the post of Ordinary Board Member, with the
portfolio of Outreach and Strategy
G ordon MacDonald for the post of Ordinary Board Member
and Chairman of the GMP Committee.
In addition, the recipients of the BARQA Award for 2011 were
David Butler and Joy Eldridge. This award is presented to
individuals on the basis of extended, outstanding service to
the Association.
During the BARQA conference the first Memorandum of
Understanding between BARQA and SARQA (Swedish Association
of Research Quality Assurance) was signed and we look forward to
new collaborations between the two associations in future.
The BARQA Annual Conference for 2012 will be held at the
Midland Hotel in Manchester on 7th-9th November 2012. The
programme for the conference is already being prepared by the
Programme Committee, this year being chaired by Allison Jack.
It was a fantastic opportunity to attend the 3rd Global QA
Conference, hosted by JSQA in Kyoto, with over 900 delegates
attending. It was great to see several presentations from BARQA
members and also the MHRA, in the conference programme.
During the conference the Memorandum of Understanding Promotion of BARQA
between BARQA, JSQA and SQA was re-signed. In support of this
BarQa oFFiCE
collaboration, a meeting was held between BARQA and JSQA’s
International Committee to determine how best to work together We know that many members promote BARQA
British Association of Research
Quality Assurance in the future and provide benefits to the members of on a daily basis and to make this easier we have
3 Wherry Lane Ipswich both associations. produced some information cards for people to
Suffolk IP4 1LG
Recent Developments hand out.
T: [phone] A sub-committee of the Board was recently established to These will be available at all events and
F: [phone]
review progress against the strategy and to prepare a strategy to
Email: [email protected] meetings, alternatively please contact
take the association through to 2016. A draft strategy has been
submitted to the Board for review and further development by the [email protected] if you would like us to send
Committees. Further discussions are taking place with a view to you some.
completion early in 2012.
Best Wishes
Rachel
JAN ‘12 Quasar05
FEATURE
Board
Biography
MiChaEl BEan
Michael has been a member of the
BARQA Pharmacovigilance Committee
since 2008 when he returned to the
Pharmaceutical industry after being an
MHRA Inspector for nearly five years.
He is a graduate from Nottingham Trent University with a
BSc (Hons) in Applied Biology. His first role in industry was
at Huntingdon Life Sciences, where he spent four years in
the Quality Assurance Department working mainly in GLP
compliance. A move to the north of England followed when he
became a GLP QA Advisor at Central Toxicology Laboratories,
which at the time was part of Zeneca Pharmaceuticals but,
as usual in the pharmaceutical industry, while sitting at the
same desk, he worked for Zeneca, AstraZeneca and then
Syngenta. In 2001 he decided that a change was called for and
he joined Novartis to explore the new and developing area of
pharmacovigilance auditing.
In 2003 Michael successfully applied for a position at the
MHRA as an Inspector. While at the MHRA he became both
a Senior Inspector and the Operations Manager responsible
for the day-to-day management of the pharmacovigilance
Inspectors. During his time at the inspectorate he focused
on developing the statutory pharmacovigilance inspection
programme, recruitment, training and development of
inspectors. He also contributed to the review of legislation both
from a national and European perspective. Michael also helped
to develop the EU pharmacovigilance inspections programme
and train inspectors from other regulatory agencies.
Michael left the MHRA in February 2008 to join Johnson and
Johnson where he currently is the EMEA Regional Head of the
Global Systems Quality Assurance Group. He is responsible for
the audit programme covering country office audits, GCP and
pharmacovigilance system audits, as well as audits of external
service providers and marketing partners. Michael has
earned a reputation for thought-leadership and has extensive
knowledge of various GxPs, both in industry and in the
regulatory environment. He strongly believes that engagement
is the key to transformational change.
0066QQuuaassaarr JJAANN ‘‘1122
FEATURE
Sources of Root Cause
Analysis Failures
Mark ParadiEs
By now, all pharmaceutical quality problems should be solved.
After all, regulators have long required companies to solve
problems. But warning letters from the US Food and Drug
Administration (FDA) prove that companies still have root cause
analysis failures. When root cause analysis fails, companies
fail to solve problems (prevent the problem’s recurrence) and,
thereby fail to ensure the safety and effectiveness of the drugs.
JAN ‘12 Quasar07
FEATURE
‘…Your firm’s OOS investigation relating to impurity levels for
(b)(4), lot (b)(4), concluded that the root cause was a laboratory
error, but the investigation did not identify what specific laboratory
error occurred. … Your response indicates that you will revise your
procedure for conducting OOS investigations, YIS-HIN-0003, ‘SOP
on OOS Investigation.’ Please note, that it is critical that your firm
thoroughly investigate all OOSs to determine the root cause.’4
These are just four sample letters. Many more are produced
each year and are available at the FDA website: www.fda.gov.
FDA letters identify failures to perform root cause analysis,
failures to document the scientific basis of the problem
investigation and inadequate root cause analysis with the root
causes listed as human error, bad handwriting and failure to
follow a procedure.
These failures are not limited to US pharmaceutical
manufacturers – they happen around the world. Root cause
analysis failures are an international phenomenon.
To prevent these common root cause analysis failures, one
must understand them and what needs to be done to prevent
them. Understanding four common failure sources and the
actions a regulated facility should take to make sure their root
cause analysis doesn’t fail is a start to the improvement of root
cause analysis in any industry.
Failure Source 1: We don’t do root cause
Why do pharmaceutical companies and companies involved
in pharmaceutical testing have problems with root cause analysis…we just solve problems
analysis? This article discusses four sources of root cause A common mistake made by problem solvers around the world
analysis failures: (not just those in the pharmaceutical industry) is that they
1. We don’t do root cause analysis…we just solve problems skip the whole root cause analysis process. When they see a
problem, they jump to conclusions and implement a fix. This
2. We ask ‘Why’ five times
reminds me of a quote commonly attributed to Albert Einstein:
3. We gave management what they wanted
4. The problems were too small for root cause analysis
The article also provides ideas to avoid these failures in the “We can’t solve problems
future with suggestions for senior managers.
by using the same kind of
Introduction
thinking we used when
A warning letter from the US FDA is big trouble. It can mean
product recalls, additional inspections, third party audits, we created them.”
rejection of data in applications or removal by the FDA of the
rights to distribute pharmaceuticals in the United States. Here alBErT EinsTEin
are four excerpts from FDA letters indicating that a regulated
facility is in trouble because they did not perform adequate root
causes analysis and then fix the sources of the problems:
Problem solvers often see ‘human error’ as the cause.
‘In your response, your firm states that you plan to evaluate all They then jump to common conclusions – the three standard
critical process parameters and that those results will be reviewed corrective actions. What are the three standard corrective
to determine final operating ranges. Your response, however, is actions? They are listed in the book, TapRooT® - Changing the
inadequate in that it does not address: 1) specific details about your Way the World Solves Problems5:
re-validation plans and in particular, whether you will determine
1. Counselling/Discipline – Which often starts with, ‘Counsel
the root cause to clearly demonstrate a full understanding of your
the employee to be more careful when.’
products and processes before initiating the re-validations,...’1
2. Training – As in ‘conduct more training’ or ‘retrain’.
‘…your approach to investigating sources of contamination
3. Procedures – Write one if you don’t already have one or
in bioequivalence studies is inadequate and has resulted in the
make the one you have longer.
submission of invalid data to the agency. You should have conducted
Using this ‘same kind of thinking’ doesn’t get us beyond our
a systematic and thorough evaluation to identify and correct the
current knowledge and doesn’t solve the problems we face.
source of contamination when it was first observed.’2
This is why the FDA sees problems happening over and over
‘Investigations related to Field Alert Reports (FARs) submitted again. It’s why the FDA becomes concerned that a company’s
to the agency during 2009 and 2010, regarding your packaging corrective actions are not going to prevent future recurrence of
and labeling system are found to be inadequate. Your inability to a quality issue.
implement appropriate corrections to prevent future significant And by the way… anytime one sees a ‘re’ anything as a
problems raises concerns regarding the robustness of your quality corrective action – retrain, reemphasise or review – an action
system… that didn’t work the first time to stop a problem is being
re-used. What will make it work this time?
Your investigation into the April 12, 2010 event attributed the root
The obvious fix to this failure source is to perform a detailed,
cause to a human error. ... Your investigation regarding the March
systematic, root cause analysis. But, as the following sections
24, 2011 event also attributed human error as the root cause of
will show, this may not be as easy as it seems.
the problem. … We are concerned with your inability to conduct a
thorough evaluation of your packaging and labeling systems and
identify problems that may lead to subsequent or new incidents of
product/labeling mix-ups. It is your responsibility to determine the
appropriate corrective actions that will reduce the possibility
of future product/labeling mix-up problems.’3
08Quasar JAN ‘12
FEATURE
Failure Source 2: We ask “Why” five times Developing a system that uses advanced human factors and
equipment troubleshooting techniques to guide investigators
The most common root cause analysis technique written about
to the real root causes of quality issues isn’t easy. One needs to
in quality journals is ‘5-Whys.’ This technique is simple and
build the right guidance without creating too much complexity.
easy to understand. In theory all one has to do is to ask and
As W. Edwards Deming said:
answer the question “why” five times and the root cause of a
problem will be found.
Examples of this technique are often given to prove how easy
“Lack of knowledge…that
and effective the technique is. Taiichi Ohno, the creator of the
‘5-Whys’ technique, is often quoted6 as using this example to
is the problem. You should
teach his students the way to ask why five times:
1. “Why did the robot stop?” not ask questions without
The circuit has overloaded, causing a fuse to blow.
knowledge. If you do not
2. “Why is the circuit overloaded?”
There was insufficient lubrication on the bearings, so they know how to ask the right
locked up.
3. “Why was there insufficient lubrication on the bearings?” questions, you discover
The oil pump on the robot is not circulating sufficient oil.
nothing.”
4. “Why is the pump not circulating sufficient oil?” W. EdWards dEMing
The pump intake is clogged with metal shavings.
5. “Why is the intake clogged with metal shavings?”
Building a system with the right questions – the right
Because there is no filter on the pump. knowledge – has been the pursuit of my professional life. That’s
To me, this as an example of troubleshooting, not root cause why I would caution those looking for an advanced system to
analysis. beware of those that haven’t done their homework. Seemingly
insignificant errors in the way the root cause analysis is
Troubleshooting determines the part that failed and the reason
performed, the way the information is organised and the way
that the part failed, not the root cause of the problem. Root
the questions are defined and categorised can lead to missed
cause analysis digs further into the human performance,
opportunities to solve problems (and, therefore, regulatory
management system and organisational causes of a problem.
issues). Thus, I can’t help but recommend that readers review
First, let’s start where the example ended and ask: “Why was
the basis of TapRooT®8 to understand how an advanced root
there no filter on the pump?” Did the designer neglect to include
cause analysis system should function.
it? Or was it removed and never replaced during maintenance?
Surely if the filter wasn’t replaced during maintenance, then this
is a human error! Now all we have to do is to pick one or more Failure Source 3: We gave management
of the standard corrective actions, for example, counsel the what they wanted
mechanic to be more careful when replacing filters, and then
Management really wants the problem to go away. But they
we have reached a common conclusion to a ‘5-Whys’ analysis
also want a simple, no cost answer they can quickly implement
(in this case with only six whys).
and forget.
Therefore, even in a ‘6-Whys’ analysis, the root causes of failed
Sometimes these are opposing goals – effective solutions vs.
human performance aren’t reached. It is unlikely they will
simple, easy corrective actions. The easiest answers to present
be reached with more “why” questions because most people
to management may be the ones they are most familiar with –
asking the “why” questions don’t have training in the causes
the standard three corrective actions.
of human error. Why people make mistakes is beyond their
Unfortunately, most real problems aren’t solved with simple,
current knowledge.
no-cost solutions. Sometimes the effective solutions require
Second, even if the pump needs a filter, where did the metal
capital projects, changes in work processes, management
shavings come from? Was the system contaminated during
attention or, even worse, management change. Finding the
assembly? Is a part wearing inappropriately? The world’s
right answer (or answers) requires thorough root cause analysis.
foremost expert in ‘5-Whys’ root cause analysis (Taiichi Ohno)
But even with root cause analysis, problem solvers and
has missed a whole line of inquiry. This isn’t just a problem for
management may have a hard time developing an effective
Taiichi Ohno. Addressing a single causal factor when there are
corrective action. They can’t see ‘outside the box’ – beyond
several is a common mistake made by those using ‘5-Whys’.
their current experience. Management needs problem
This single, well-known example shows two of the built-in
elimination. That’s why an effective root cause analysis system
problems with asking why five times. But one may need more
needs to go beyond asking effective questions to find root
evidence to be convinced to abandon a common root cause
causes. An effective system needs to help problem solvers and
analysis tool. Thus, I refer readers to a detailed discussion of
management consider potential solutions that they might not
five reasons ‘5-Whys’ fails to produce acceptable results in the
think of on their own.
article ‘Under Scrutiny’7 in ‘Quality Progress’.
The job of a problem solver is to provide a thorough analysis
If one is using the ‘5-Whys’ technique and experiencing the
based on evidence and then develop effective actions to prevent
same inadequate results that others frequently experience,
recurrence. The problem solver, with the help of the root cause
what can one do? Adopt a more advanced root cause analysis
analysis system, must confront the real issues effectively.
system based on the proven human factors and equipment
To stop investigators from just telling management what
troubleshooting techniques.
they think management wants to hear (simple corrective
actions from the standard three), management asks for
better solutions. Thus, management needs advanced root
cause analysis training so they know what to ask for.
Also, the root cause system used should help the problem
solvers see outside the box. It should get them beyond their
current knowledge and help them develop fixes based on the
latest human factors and equipment reliability technology.
Thus, an advanced root cause analysis system has to
provide expert systems for root cause analysis and guidance
for the development of effective corrective actions.
JAN ‘12 Quasar09
FEATURE
Failure Source 4: The problems were too Management can use the ‘fact’ that nothing big has happened
as proof that things are safe and quality is acceptable.
small for root cause analysis
Unfortunately, this is exactly what management thought before
Many times I’ve heard: every major accident or quality fiasco on record.
“We simply don’t have time to do analysis of all the small To avoid this failure, management must be concerned with
problems that we have. We must use simple analyses for small failures and make sure the ones that could result in
smaller problems.” major problems are thoroughly investigated using advanced
And then thought…bad analysis of small problems allows root cause analysis and, once investigated, that the corrective
bigger problems to happen. actions are implemented. Constant vigilance is the price of
Most would agree that solving big problems by never letting operational excellence.
them occur in the first place is probably the best medicine.
After all, would the CEO of a major oil company prefer to wait Conclusion
for an accident like the Deepwater Horizon to learn to improve
Senior managers: don’t fall victim to the common problems
your drilling operations or would they rather heed the warnings
that produce root cause analysis failures. Avoid major quality
of smaller incidents and, thereby, prevent the major accident
issues and FDA warning letters by effectively using advanced
from happening?
root cause analysis. To improve your root cause analysis
I’ve never seen a major accident that didn’t have precursors.
processes, start with these four action items:
Sometimes these are called ‘weak signals’ but for people
experienced in achieving operational excellence, they are 1. Make sure that your facility performs advanced root cause
warning sirens that should not be ignored. analysis to develop effective corrective actions, and that
Why then do many companies miss the signals in incidents your problem solvers aren’t jumping to conclusions.
and near-misses? Besides failure to perform adequate root 2. Don’t allow the use of ‘5-Whys’ and don’t accept
cause analysis (mentioned previously), there are several substandard root cause analysis. Remember, human error
reasons. They include: is NOT a root cause.
1. Complacency 3. Get training for your management team on advanced root
2. False sense of economy cause analysis and demand more than ‘simple’ answers.
Ask for thorough root cause analysis that uses advanced
3. Short-term focus
human factors and equipment troubleshooting techniques
4. Failure to understand how to achieve operational that develop effective fixes beyond the ‘standard three’. And
excellence never accept an answer that starts with ‘re’.
Missing the opportunity to avoid major accidents by learning 4. Develop a screening process to catch important smaller
from smaller problems is even more of a tragedy when one incidents (near-misses) and ensure that these smaller
considers the financial and personal losses that occur in a incidents get advanced root cause analysis and effective
major accident or quality issue and how much easier it is to corrective actions. Then insist resources are applied so
learn from a small problem. that learning from these small problems prevents major
Why is it easier to effectively learn from a small problem? accidents and quality issues.
Because small problems are easier to analyse. There is less
Once your reactive learning processes are optimised, you
blame to get in the way of the investigation. All the witnesses
will be ready for the next step in operational excellence –
are alive and willing to cooperate. Live witnesses aren’t
developing proactive processes using the same advanced root
‘lawyered up’. Management is much less defensive and the
cause analysis tools to get an additional step ahead of trouble
company isn’t lawyered up. Usually there isn’t perceived
and become a true learning organisation.
pressure from regulators.
Then why don’t companies learn from small problems?
First, companies need an effective screening process to
pick which small problems could become big problems.
Management can then direct problem-solving resources Mark is President of System
troe ttuhren p orno bthleem insv wesitthig tahteiv ela ergffeosrtt .possible risk-based Improvements in Knoxville, Tennessee,
Second, management has to avoid complacency, a USA. He is co-author of TapRooT® -
false sense of economy and a short-term focus and then Changing the Way the World Solves
concentrate on achieving operational excellence. The need Problems, a contributor to the Root
for this can be less than intuitive when only small things are Cause Analysis Blog and the editor of
going wrong. the Root Cause Network newsletter.
He is a member of the IEEE Committee
REFERENCES writing a root cause analysis standard
1. FDA Warning Letter to Impax Laboratories dated May for the nuclear industry and is a
31, 2011. co-author of the book Guidelines
2’ FADprAil W26a,r 2n0in0g4 .Letter to MDS Pharma Services dated for Investigating Chemical Process
3. FDA Warning Letter to Aurobino Pharma Limited dated Incidents published by the Centre for
May 11, 2011. Mark ParadiEs Chemical Process Safety. Mark earned a
4. FSDepAt eWmabrneirn 2g9 L, e2t0t1e0r .to Kyowa Hakko Kogyo Company on Master’s Degree in Nuclear Engineering
65.. “wtS MhEyoaexsrr atdWkemp maPrpyea lIstremhas oe/dpaf irW er5ocs-voh Wearimlvnhded yesS snL/o”1til ns0vh,de0t Itas1np cUP(:A/.rn/,u ow2ggb0weul0rews,8m t.T),t aas12p p10(RKr70o.on7oo)ot.Tx.cv®oi l-mle C,/ hTaNn:g ing Aaitnh mC ethe eUreritn ciNifaviuenecd rSls eHoiatcayriz eNoatfayr dI vlf loyCirn ao Qonniudtsr.a o iHslli etMay w .aCnaewasr tgicitfeehirre .at diHnf iPe eer dimos fb peaysh s saNeisoaninvisoas orel n maE h r0egu8mom anbsaoe nmar nofiasf e tctn htaogenri sdn eaet r
7. M ark Paradies, “Under Scrutiny” Quality Progress
(April 2010) available online at http://asq.org/quality-
progress/2010/04/quality-tools/under-scrutiny.html.
8. “ How Does TapRooT® Work?” http://www.taproot.com/
wordpress/archives/496 (2004).
10Quasar JAN ‘12