Beruflich Dokumente
Kultur Dokumente
Technology Centre
Content
everywhere
Launching
More April
CPD Knowledge
email
In print Online On mobile
The way we consume content is changing. Using feedback from members,
the CQI has redeveloped its content package to provide you with more content
in more places.
You can now access the QW archive online or download the digital edition,
find extra features on the website, receive the new Knowledge email for
technical articles, and read CQI and IRCA news in the Members Update email.
Launching
April More More
Members knowledge debate
Update
NEW
ISO
progressed to nal draft stage; this is a great
time to start planning and preparing for the
ses
new changes.
ra
n s iti o n C o
ur
T
New Standard Transition Public Training New Standard Transition Support
ISO 9001:2015 Whats it all about then? Understand and In-House Training: All of our transition training can be delivered
learn about the structure of the new standard and the revised In-House, which will ensure the training is tailored to your
management principles, the high level management system management system and team making the training specic to
framework and the difference between the most recent and your objectives.
previous standard.
Gap Analysis: This assessor delivered activity offers you a chance to
Preparing for ISO 9001:2015 How you can plan for and approach
focus on the weak areas of your transition to the new standards.
the changes within the new standard. Learn about the concepts
So whether you are in the early stages of transitioning or just want
and requirements that will be dened in ISO 9001:2015, the
a dry run before your transition visit, this is an ideal service to give
signicance of organisational context, risk-based thinking,
you and your team condence that you are on the right track and
leadership and the enhanced requirements concerning
what you still need to do to meet the new requirements.
process management.
ISO 9001:2015 for Internal Auditors Build on your existing Pathway: To support you during the new standard revisions we have
internal auditing experience and learn about the latest standard created a free to use transition online tool. This self-help tool has
revisions and how they will affect your systems. Learn how to been designed as a simple multi choice checklist for you to clearly see
audit the requirements concerning organisational context, how you are progressing with implementing the new changes and
risk-based thinking, the process approach and leadership. also highlight areas you need to focus on before your transition visit.
ISO 9001:2015 Lead Auditor Transition Upgrade your
knowledge to the new standard. Learn the structure of Annex SL, Transition Advisory Line:
the signicant new and enhanced requirements of ISO 9001:2015
and how Annex SL has been applied to ISO 9001:2015. 0800 014 9152 | transition@lrqa.com
Improving performance,
reducing risk
Lloyds Register and variants of it are trading names of Lloyds Register Group Limited, its subsidiaries and afliates.
2|Lloyds
Quality World | February
Register Quality2015
Assurance Limited 2015. A member of the Lloyds Register group.
From the editor Contents
FEATURES REGULARS
14 04
Inside Sony News and Analysis
QW goes behind the scenes at the NHS whistleblowing, super-prison
Sony UK Technology Centre to learn risks and the nuts-for-spices scandal
the secrets of its quality culture and
Welcome to your new-look QW. Alchemy coding system 08
We hope you like the fresh look and feel CQI and IRCA news
of the magazine, but the most important 20 Annex SL briefings annouced,
change lies in the content. Were striving Taking Medicine Global plus news from the CQI Medical
to deliver more value per page by AstraZenecas Peter Deegan explains Technologies Quality Group
bringing you more insight from leading the challenges for pharmaceutical
authorities, combined with more articles quality and auditing in the global 12
focusing on CPD and learning. And now supply chain, and how outsourcing Opinion
theres more online too. Look out for is modernising the industry Quality as a way of thinking and
the yellow action boxes for directions to How to drive business success
extra content, and p13 for the highlights. 26
Robert Gibson Product Recall 13
As Honda stalls amid the latest Digital highlights
Cover photo: Richard Osley
automotive recall revelations, Where to find the best bits online
David Hutchins examines the truth
Quality World +44 (0)20 7245 6676 behind the trends and the pressures 32
editorial@thecqi.org Twitter: @Qualityworld
facing all manufacturers Knowledge
Content Manager Robert Gibson JJ Lynch explains why people
Content Creator Amanda Pauley
Content Creator Natasha Cowan 20 work best when they feel good
Senior Designer Ricky Elizabeth about themselves
Advertising
Jude Rosset jude.rosset@redactive.co.uk 36
Subscriptions Accreditation
+44 (0)20 7245 6866 Jeff Ruddle explains how to align
qwsubscriptions@thecqi.org
11-issue subscription fees accreditation with an innovative
UK: 72 Europe: 92 ROW: 110 approach to business
Print and distribution by Warners Midlands Plc
ISSN 13528769. Vol 41 issue 4 38
Reviews
Sustainable Business Key Issues
and Making Your Work Work
The views expressed in QW are those of the author and do not necessarily
represent those of the CQI. The advertising of courses, events, products and
services in this publication does not imply that they have CQI endorsement.
Reproduction of QW in whole or part without permission is strictly prohibited. 44
5 minutes with...
Steve Warwood, FCQI CQP,
Chair of the CQI Advisory Council
thecqi.org | 3
News and Analysis
The news The views The analysis
Her Majestys Inspectorate of Hardwicks recommendations that Dr Marilyn Dyason, MCQI CQP, has
Prisons for England and Wales lessons need to be learned ahead of many years experience in the criminal
(HMI Prisons) has cast doubt on any new ventures were made in a justice system as a senior manager and
government plans to build the UKs new report into Oakwood. He said: Justices Chief Executive. She said: An
first super-prison. The determined way the director organisations reluctance to conduct a
It claims the project carries and staff [at Oakwood] have made strategic review is always a warning sign
uncertain dangers, warning improvements following significant to the quality professional.
that early difficulties in opening criticism should be acknowledged. The review called for by the Chief
an existing large jail led to However, the difficulties Inspector of Prisons would provide an
unacceptable risks and very Oakwood and other new prisons opportunity to identify the lessons to be
poor outcomes. experienced immediately after learned in advance of moving to a super-
The watchdogs Chief Inspector opening resulted in unacceptable prison model, having found success in
of Prisons, Nick Hardwick, has risks and very poor outcomes for Australia.
called on ministers to undertake the prisoners held at the time. As any serious benchmarker
a review of the problems faced Jerry Petherick, Managing will know, it is never a good idea to
at HMP Oakwood, a large prison Director of Custodial and Detention transplant ideas from a successful
that currently holds 1,600 inmates. Services at G4S, welcomed the organisation to another without ensuring
Operated by security contractor findings. the right foundations are in place
G4S, it was beset with violent He said: Opening any prison is a leadership, culture and competence of
disorder and drug abuse soon after complex process and our experience people. Such foundations are now, albeit
opening three years ago. shows that it takes time to develop belatedly, in place in Oakwood and being
Hardwick has suggested the experience of staff, fully embed built upon. A failure to review and learn
that lessons from Oakwood are the prison regime and establish can only result in an opportunity lost
factored into plans for the opening links with local partner agencies. and on a super-scale.
of other new establishments. However, The Howard League
However, justice ministry officials for Penal Reform, a national
indicated there would be no review. charity that opposes the
Secretary of State for Justice, Chris warehousing of prisoners
Grayling (pictured below) plans to in large institutions, was
open the UKs first super-prison in quick to describe the
Wrexham, North Wales, in 2017. Wrexham project as
The facility will have the capacity a titanic mistake.
for more than 2,000 inmates.
Nuts-for-spices
scandal leads FSA to
investigate food chain
The news The views The analysis
The Food Standards Agency (FSA) has It has yet to be established whether the Professor John Oakland, FCQI CQP,
launched an investigation into the potentially substitution is intentional or accidental Chairman of Oakland Consulting, said:
deadly substitution of nuts for cumin in in each case, although experts fear it The mantra heard in the early days of
Britains food chain. could be a case of food fraud even more health and safety at work legislation was
Multiple cases have emerged where dangerous than the horsemeat scandal. safety is everyones business. In reality,
products claiming to contain cumin have Professor Chris Elliott, who led the everything is everyones business, but
included almonds that were not declared Governments inquiry into the horsemeat becomes nobodys business in the absence
on the packaging. The inclusion of almonds scandal, has put the UKs half-a-million of clear leadership.
could prove fatal to those suffering from nut nut and legume allergy sufferers on high The wilful inclusion of nuts as a
allergies. Cumin is one of Britains most alert. He said: This is the first real test contaminant in food products that shouldnt
popular ingredients and substituting it with of the integrity of the UK food supply contain them is nothing less than criminal
peanuts or almonds can inflict a range of system since the horsemeat crisis and negligence, especially when there are
suffering, from mild symptoms to abdominal its actually much, much more serious. vulnerable people in the world who can
pain and cardiac arrest. If you happen to be allergic to easily die from eating them.
As QW went to press, the nuts-for-spices almonds or peanuts there is the potential If the owners and directors of such
scandal continued to escalate, with a fourth of getting ill or even dying because of it. companies cant trust themselves to manage
product being recalled from shelves and So the challenge is there. this vital part of the business correctly and
experts claiming that some paprika dishes Whenever theres a crop failure deliver safe products, then they should
may also be tainted with almond or peanut. you always have to look to see what is employ the services of experienced quality
The UK has joined forces with governments the potential fraud that is behind that. professionals who will. We can prevent
in the EU, US and Canada, along with food This time the crop failure is cumin and damage to their customers by eliminating
companies and trade associations, in a bid to it does seem to be that there has been nuts from their products or, at a minimum,
determine the scale and source of the threat. fraud going on. have them clearly and correctly labelled.
thecqi.org | 5
News and Analysis
Image: Cathy James, Chief Executive of
whistleblowing charity Public Concern
at Work (Chris Renton Photography)
thecqi.org | 7
CQI and IRCA news
Yokohama
Japan
23 May
Seoul Korea Hosting the ISO standards in
the future: spare me the jargon
29 May session at IRCAs Japan Forum
2015. Book your ticket:
Presenting an ISO update
seminar in collaboration with irca.org/2015forum
the Korean Auditor Register.
24 May
Leading an intensive one-day
ISO 9001:2015 Auditor
Update Training session.
Tokyo Japan
26 May
Singapore
Leading an intensive one-day
ISO 9001:2015 Auditor
thecqi.org | 9
CQI and IRCA news
Event:
CQI Greater
Manchester
meet Concorde
The CQIs Greater Manchester
branch were flying high
when they went on a tour of
Concordes Runway Visitor
Park in February. Led by John
Hepple, Concordes Senior Tour
Guide, members learned about
the aircrafts unique features
and innovative design, as well as
getting the chance to have their
picture taken in the cockpit.
The event ended with a Q&A
on topics such as engineering an
aircraft capable of supersonic
travel, quality of detail and why
customer comfort is a top priority.
Treasurer of the CQI
Greater Manchester branch
Victor Williams (below) said:
Kevin Mark
Brown Eydman
on thinking on driving
quality success
A A
s a profession, and disciplines to optimise t the heart of approach, but do the actions
we have long their output in the context every successful always match the words?
moved away of the entire enterprise and business lies the A simple test is to review
from the idea of its stakeholders. Quality is requirement the key business decisions
quality as the preserve of the about instilling a way of for a compelling value being made at board level.
specialist working outside the thinking in everybody. proposition. This should These decisions would be
production or service line. I am pleased that the be built around the supply considered as strategically
We understand that every new CQI Competence of products, services and important. In associated
department and discipline Framework seems to be solutions to one or more discussions, to what
must build quality into lifting the sights of the market groups. extent are the impacts on
everything they do. quality professional to a level But what else is required? employees and customers
We understand where the way of thinking In our KPI-dominated explicitly considered
that quality systems by is more important than the management culture, which in a way that provides
themselves can only tools and knowledge. is focused on the short-term, comparison with the
have a limited impact on We can all think in terms great attention is given to anticipated internal financial
the performance of an of governance, assurance the drive for efficiency, this improvement?
organisation. and improvement at is not in itself something to If this consideration is
The quality professional whatever level we operate, be downgraded or avoided. not explicit, it is highly likely
can provide the tools, in whatever context we Unfortunately such that short-term financial
knowledge and even wisdom find ourselves. single-minded focus can gain is taking precedence
to help departments, The quality way of fall short of the more over potential negative
disciplines and whole thinking starts with an nuanced approach capable impacts to employees and
businesses achieve quality. open mind about choosing of far more dramatic customers.The stakeholders
But is quality itself which tools, systems and results and, at its worst, will remember the treatment
a discipline? My background approaches to use, as well as can in fact contribute to that they received long after
is in energy and engineering, which questions to ask, and significant reductions in the the improved monetary gain
where many businesses and which people to talk to in effectiveness of efficiency- has faded from memory.
project teams are structured each new scenario. driven actions. I do not offer this model
with quality as a discipline It knows that every I am a passionate believer from starry-eyed innocence,
alongside mechanical, situation is different if the in a simple business model but long experience of
electrical and safety etc. people are different. It resists where customer loyalty, seeing dramatic results.
The quality team has its cultural preconceptions. employee engagement and This discussion lies at the
objectives and deliverables It is now time to let go organisational effectiveness very heart of any definition
just like any other. of certainty, embrace the are all contributing to of quality. Our profession
But quality isnt like other unknown and begin to the long-term profitable has the ideal individuals to
functions it isnt flying the think creatively. growth pursued by most advocate use of this model
flag for any particular aspect Kevin Brown, MCQI organisations. and drive resulting success.
of the project, product or CQP, Director and I am sure that most Mark Eydman,
service. Quality is trying to Principal Consultant at leadership teams would MCQI CQP, Senior
persuade all the functions Qfactorial Ltd be quick to endorse this Business Leader
Inside Formula 1 Estelle Clark How to get noticed 10 ways to engage your directors
Formula 1 expert and CQI Conference Quality should always be at the Jason Arkell took on the challenge of
speaker Mark Gallagher explains the forefront. CQI chair Estelle Clark tells getting quality recognised as a key
skills quality professionals can learn us about her unique communications differentiator at oil and gas company
from an industry built on speed, and techniques and her top tips for Amec Foster Wheeler. He shares his
the true meaning of high performance. gaining buy-in at work. advice for selling quality to the board.
thecqi.org/inside-formula-1 thecqi.org/how-to-get-noticed thecqi.org/engage-your-directors
Top
tweets @Qualityworld Most read
thecqi.org | 13
How the Sony UK Technology
Centre is leading the
way with an innovative
quality culture
Words: Amanda Pauley Photos: Chris Renton
thecqi.org | 15
T
Tucked away in Pencoed, South Wales,
sits the Sony UK Technology Centre.
The facility is the organisations only UK
manufacturing and customer service
centre, and home to its manufacturing
operation for professional and broadcast
cameras outside of Japan. It also offers
its expertise to third parties such as
The Raspberry Pi Foundation, makers
of the smash-hit miniature computer
designed to teach schoolchildren the
basics of how to program.
As QW is taken on a tour through
the buzzing factory its easy to see Steve Dalton Richard Wilkins Kevin Edwards
why the company has gained its OBE, Managing Director Senior Manager for Head of Engineering
reputation as a leader in the technology Quality, Innovation and
industry. The facility lives and breathes Environmental Health
quality, with state-of-the-art Lean and Safety
manufacturing techniques, stringent
testing and a culture that has embedded
collaboration and innovation into its How does quality play a part Steve Dalton (SD): When the facility
DNA. Its also accredited to three in every aspect of the Sony UK opened more than 40 years ago the
ISO standards ISO 9001 (quality Technology Centre? majority of our senior management,
management system), ISO 14001 Kevin Edwards (KE): The quality product staff, and engineers were
(environmental management) and message is sold in many ways but one of trained by our Japanese colleagues.
ISO 13485 (medical devices). The walls the most effective is via our full factory They taught us about the techniques,
are literally lined with the organisations review meetings, which take place philosophy and culture of quality,
seven core values and behaviours twice a year. MD Steve Dalton, senior and what it means in terms of the
passion, motivation, quality, managers and various members of process, service, parts, material, and
innovation, knowledge, customer care, staff give presentations on the business people. Weve embedded these methods
and winning spirit. key performance indicators, such as into our skills and culture, and the
But how has the site set itself apart finance and efficiency, and crucially, facility in Pencoed has grown with
from its competitors? Its known for quality. Steve then sets the picture that focus in mind.
its unique understanding of quality for whats expected from the site and
and its use of methods such as every department will feed these goals How do you carry out stringent
poka-yoke (a Japanese term meaning into their teams via monthly, weekly process testing on every product
mistake-proofing). We went inside and daily meetings. We also have an you manufacture?
the Sony UK Technology Centre to induction process for new staff where KE: Our products are complex,
get a fly-on-the-wall perspective of they are given an outline of what we do, powerful and small in size, and this
life at the site and speak to the three our behaviours and a detailed history increased functionality means more
men embedding quality at every level. of the Sony UK Technology Centre. measures are being undertaken to
30,000 m2
in size
confirm the customer always gets what
they require. Our broadcast cameras
350+
are high-value items, especially when
they are shooting that Tiger Woods putt
or recording an interview that only
happens once. They have to be perfect.
staff It takes just under four hours
to confir m the functionality of
42
a broadcast camera. It involves ensuring
customer specifications are met and
that everything in the manual has been
years old
checked. We carry out this process with
automation, as well as with people,
and then the products are passed on
5
to the quality control (QC) team. The
QC team will treat the products a little
apprenticeships more roughly, flicking the switches and
undertaken last
year making sure it all feels like it should.
We simulate various conditions during
54
our testing to ensure our products meet
the quality standard our customers have
number of Japanese come to rely on. There are two sides
processes in use to the process: one where we vigorously
test to every standard and composition,
6
and the other where we make sure it
feels like a high-quality Sony product.
thecqi.org | 17
How do you determine what the
customers expectations will be
before you start manufacturing?
RW: We look at products from the
customers point of view what are
they likely to do with it? And then
try to replicate it. We have a saying
here where we try and make it fail.
Its good to confirm a product is
working but what we want to know
is under what conditions does it fail?
If we understand that then we can
plan for every eventuality and ensure
the product is robust.
How do you ensure poka-yoke How does your innovative use we try to categorise what processes
assembly processes regardless of quality tools set you apart and manufacturing techniques are
of the quantity or complexity from competitors? wasteful and inefficient, or could be
of the product? KE: Quality is a key competitive improved. Once identified, we try
KE: Fifteen years ago we began a project differentiator for our business. Its to think of new and innovative ways to
to put traceability into our operation about using everything in your quality remove them to allow what is valuable
and it evolved into a coding system we toolkit Six Sigma, 5S, Kaizen and to emerge. In turn, it also makes the
called Alchemy so named because poka-yoke but only where you need manufacturing process as efficient
we were trying to use the base metal of them. Its not a one tool fits all model and effective as possible. Automotive
the material in the warehouse and turn it takes the right mix of quality tools. manufacturer Toyota were the first to
it into a gold-standard product. The You can teach anyone the tools but introduce this type of methodology.
system was designed by our engineers the important thing is we have the
and includes full serial numbers and right people who know when to apply SD: The principles of Muda Dori
adjustment values everything you need them and how to do it effectively. come from the basis of Kaizen theory
to analyse trends and feed forwards or which, when translated, means good
backwards to the customer. If a unit RW: Our Sony Learning Academy change. There are seven items of
gets damaged in the market and comes enables our staff to undertake Muda Dori were constantly addressing.
back, we have full traceability. external courses that expose them They are: over-production, idle time,
Today, Alchemy has grown into to Six Sigma, the DMAIC model transportation, non value-added work,
a huge database system that prevents (define, measure, analyse, improve, inventory, motion and defects. Our
us moving a model or unit to its next and control), problem solving and staff know to use Japanese techniques
process until the previous process has more. Its the toolbox everybody needs to get rid of non value-added work
been completed satisfactorily this and embodies the common language and waste inside their own process,
even comes down to the packing of we all speak. We also have 30-minute production cell and office area.
the unit. You cant print the barcode in-house training courses called We constantly ask questions such
label or point-of-sale label onto the box Quality Knowledge that explain as: Where are you doing non
unless all our processes have been ticked. the importance of 5S, production value-added work in the office
Nothing leaves the factory unless it has innovation and Muda Dori (an evolving and the back-office support area?
been thoroughly processed and meets process that aims to eliminate waste). It comes down to the fact that we want
our strict quality standards. By using techniques such as Muda Dori, to be the best we can be.
thecqi.org | 19
AstraZenecas Peter Deegan is leading the quest for
quality in pharmaceuticals. Here he tells QW how
TAKING
outsourcing has brought fresh innovation.
MEDICINE
GLOBAL Words: Natasha Cowan
Portraits: Paul Worpole
thecqi.org | 21
The pharmaceutical industry
is worth an estimated 200bn.
Organisations compete to create
cutting-edge drugs that will
find their way onto the global
market, eventually ending in
the homes of billions of people Companies fail
worldwide, who rely on stringent
methods to ensure high-quality, development challenges. It provides a
when they outsource
safe products. boost on the financial market, while accountability
In recent years the pharmaceutical utilising resources with start-ups and as well as
industry has changed dramatically. universities to create groundbreaking
Externalisation the process of new products that serve the public. responsibility
striking up new deals to outsource The question everyone is asking is
drug creation has become the norm, simple how do you bring these new to bring the latest scientific thinking
and AstraZeneca is at the head of the groups into the development pipeline? closer to us.
trend. The company has spent the last The whole value chain is T h e t e s t fo r t h e i n d u s t r y
five years seeking out start-ups who changing, Peter tells QW, the is getting the process for these
have made scientific breakthroughs boundary of the research side is collaborations right. The methods
that could change the face of medicine blurring, bringing in small start-up used by each manufacturer must match
as we know it. ventures with exciting molecules. AstraZenecas standards. From an
The man at the forefront of this Traditionally, molecules were created auditor perspective, understanding the
quest for innovation is Peter Deegan, in the labs of big pharmaceutical wider context of the pharmaceutical
Head of Quality Assurance and companies and there was an identified industry is integral.
audit in the Regulatory Compliance mechanism for this process. You have to make sure to follow
area in research and development at The stakes are high, with each the science and the research and
AstraZeneca, a multinational company pharmaceutical company vying for development of those innovative
that has achieved international success a place on the global market. A new drugs, and balance this with efficient
and featured on numerous lists of the system had to be implemented that and effective processes. Outsourcing
top 10 pharmaceutical companies in would allow innovation to thrive both activities means working with new
the world. He has been handed the task within the laboratories and externally. companies and new interfaces.
of providing assurance across a highly Innovation is definitely still
regulated value chain. What makes alive within our organisation, Peter ISO 9001
his job that much more difficult is the explains, but it is challenging for Peter is an expert in working closely
variation in regulations in different a large pharmaceutical company with new partners as part of this
countries across the globe. to deliver innovation solely inside outsourcing initiative. His rise to the
its own walls. Exter nalisation top is based on a simple approach:
Blurring organisational brings excitement, innovation and ensuring clarity. I think one of the
boundaries entrepreneurialship right to the core of most valuable lessons I learned on
Externalisation has become a core AstraZeneca. We want to be walking the IRCA certified ISO 9001 Lead
strategy for overcoming research and among the Nobel Laureates in science, Auditor training course was that the
thecqi.org | 23
end-to-end internal processes usually
work, but the interfaces often fail.
AstraZeneca operates with a policy
of due diligence, making sure that
every person or organisation they
partner with is thoroughly investigated
prior to signing a contract. For Peter
this is essential for success.
H av i n g t h a t c o r e s e t o f
AstraZeneca policies allows us to
approach our new alliance partners
or outsourced partners with very clear
standards, he states. You have to
provide clear standards that you
attribute your organisation against.
If you can articulate those documented
standards, policies and procedures,
then at least you can approach those
partners with a very clear statement
of intent.
Transparency can mean the
difference between successfully
courting an award-winning foundation
and missing an opportunity. It can
truly make that organisation say, Wow,
across many standard operating
procedures, some of which had similar
for safety reporting are
not well established and
The whole
this is a differentiating company, and requirements. value chain of
it is easier for safety issues
we want an alliance with AstraZeneca AstraZeneca set a new global to go unreported. the company
because we share those quality values. compliance standard in the regulatory For Peter such issues
Bringing AstraZenecas vision compliance area, reducing their critical come as part of the is changing
to reality comes with its difficulties. standard operating procedure set territory. Having worked the research
Peters job is to ensure this strategy
comes to fruition and guarantees the
from 123 to 12. The new standard
acted as a key umbrella statement,
in both manufacturing
and research and
side is blurring,
sustainability of quality practices. I explains Peter. The benefit was development for more bringing in small
think in general its challenging for that the affiliates were able to gain a than 30 years he is well start-up ventures
large corporations to deliver innovation more focused understanding of the versed in communicating
at that micro level, says Peter. When standards. with far-flung areas with exciting
you follow the science it doesnt matter In creating this system, Peters team o f t h e g l o b e. Yo u molecules
whether you have a huge alliance realised compliance gaps had similar know you work in the
with another major pharmaceutical patterns across similar regions. To pharmaceutical industry when you
company, or a small university counter this he created a tailored speak to people in Japan, South Africa,
start-up. If you can do that you compliance improvement plan, Argentina, France, and India this week,
can break down a lot of barriers including regional compliance training but you havent said hello to your next
immediately by not constraining workshops. Without setting a clear door neighbour this year, he quips.
your thinking. standard we would not have seen the AstraZeneca uses the
You have to make sure youve cultural differences in interpretation, Pharmaceutical Quality Management
got a common purpose and a common he says. System ICH 10 (Inter national
vision as an audit group and embed Conference on Harmonisation), a
some common consistent audit Culture shock standard that brings together the
practices and disciplines. Auditing on a global scale involves original pharmaceutical technical
One way Peter has achieved this is overcoming cultural boundaries. codes with ISO 9001, stating that ISO
by reviewing the compliance standards National statutes, rules, regulations, quality management guidelines form
across global activities. He says: We and laws vary from country to country. the foundation of the system. The aim
found these standards were spread In emerging markets national systems of ICH is to harmonise pharmaceutical
Changing lives
The pace of change can seem staggering.
As AstraZeneca strives to increase its
portfolio innovation remains crucial
to the way Peter and his team operate.
Creating cutting-edge but accurate
You can break approaches will make sure the
down a lot organisation can de-risk its development
pipeline, guaranteeing protection for the
of barriers millions of people taking AstraZeneca
immediately by drugs every day.
For Peter continuous improvement is
not constraining ingrained in the future of quality. To me
legislation and guidance worldwide, your thinking it is 21st Century quality management. I
and it recognises the multitude of think the 20th Century way of thinking
statutory instruments in each country. As a company, AstraZeneca tackles was based on quality control and quality
Peter says: Embedded in ICH Q10 inconsistencies through implementing assurance and thats been the right
is a culture of continuous improvement a culture that embraces diversity when path up to now, he says. The modern
with the need to understand the auditing. If you have a common approach is the ability to change and
root cause of problems and put in auditing approach across global rapidly improve. This is a differentiator
corrective actions to fix errors. One of processes with diverse national and I think it will give companies
the most important aspects of this for regulations, you reduce the risk competitive advantage. The advice
me, as head of audit, is whether the of being unable to interpret those from a 21st Century auditor may be
organisation is continually improving regulations consistently, Peter says. that you can be creative about how you
to prevent reoccurrences. Companies We dont impose a way of meet the necessary compliance standards
fail when they outsource accountability working, we embrace different cultures. if it will achieve better assurance and
as well as responsibility we dont I can only ask a company to show me will drive continuous improvement.
do that. how theyre meeting the standards. I Pe t e r h a s p rove n t h a t a n
Within AstraZeneca, we maintain cant impose my way of doing things. understanding of context, cultural
that oversight and as a result we have a National governments may require differences and innovative techniques
very clear and active audit programme different ways of working and language is crucial for ensuring quality. His
of the suppliers against some very may well be different, so its up to me career in manufacturing and research
core standards. as an auditor to listen, see and interpret and development has been based on
Within our suite of policies is our that diversity. Its a true challenge, the firm understanding that his role is
Quality and Compliance policy. It but at least we have a common audit crucial for ensuring the best possible
states that everyone takes ownership methodology like the ISO 9001 system, outcome for patients. Thats what other
of quality and we must have senior so our auditees know what to expect. organisations can learn from us, says
management commitment. Senior This is a personal motivation Peter. We focus on our patients and
governance committees oversee quality for Peter. In the past he ran cultural understand how auditing really drives
to ensure we are meeting regulations awareness courses teaching westerners the assurance of safety, quality and
and doing the right thing. Compliance, about Japanese culture. efficacy of our products through that
oversight and ownership are embedded Its all about respect and culture of quality. Thats what is really
in our culture. credibility, he says. It is important important.
thecqi.org | 25
26 | Quality World | April 2015
From faulty airbags and accelerators,
to contaminated water and dangerous
toys, product recalls seem to be on the
rise. But whats the reality and how are
businesses responding? CQI Fellow
David Hutchins examines the evidence
f youre a high-volume
manufacturer or chain retail outlet,
a product recall is probably one
of your worst nightmares.
It has been referred to as
death by a thousand cuts.
Recalls are reverse logistics,
whereby recalled products, information
and cash flow travel in the opposite
direction to normal. These costs are
typically more than three times the equivalent
sums for products flowing in the right direction.
Risks are higher than ever for companies that
fail to anticipate and prepare for the possibility of
a product recall.
It can take several years to complete a recall, as was
the case with Fords recall of models with Firestone
tyres. In this case it took more than seven years, from the
first report in 2000 to the final decision, according to the US
National Highway Traffic Safety Administration (NHTSA). In
fact, the time to retrieve is usually indeterminate and almost
never complete. Even with products where the original purchaser
is known and traceable, it is rare for more than 80% to be located.
The remainder of these products are an accident waiting to happen.
thecqi.org | 27
wo years ago there was a of recalls for each of the major
highly publicised recall of Toyota cars manufacturers has also remained
suffering a problem with acceleration. fairly static. According to the statistics,
Product liability has remained in the one might occasionally have a spike
limelight ever since, especially for but on average, things level off.
those connected with the unfortunate
Japanese company. The increased
publicity gives the impression that
product recalls are on the rise. Reality check
But what is the reality? In 2010 more than 20 million vehicles
were recalled in the US and the
trend among manufacturers was to
attempt to push recall liability down
to suppliers.
Reading the numbers Why then does it appear that
In the jargon of US product recall product recalls are increasing in the
statistics, the usual measure is TGW
things gone wrong. There has been
automotive industry if they remain
static? There are two reasons. Firstly,
The risks are
a decline in traditional hard TGW the media is more highly sensitised to higher than ever for
failures, for example, warranty costs
and customer reported TGW. These
automotive recalls, so they get greater
exposure. Secondly, the decrease in
companies that fail
include mechanical or physical issues, hard failures has disguised the increase to anticipate prepare
such as engine failure or problems with
seat stitching.
in soft failures.
Its reasonably predictable that
for the possibility of
However, some of the statistics are soft failures will continue to rise, a product recall
conflicting. For example, the same possibly at an increasing rate.
attribute might score poorly in TGW The theory being that this is where
and yet score well in TGR (things gone most of the innovation is now taking
right). Soft failures include issues place. The traditional mechanical
such as a product that is difficult to components of an automobile
use or understand, poor location of represented by hard failures, together
its elements, a lack of functionality with the means of manufacture
or poor materials. and supply chain management,
Surprisingly, according to statistics have been developed almost as far
Above: In 2010
provided by the NHTSA, automotive as they can go (subject to a possible more than 20
recalls among the top manufacturers technological breakthrough). million vehicles
were recalled in
have remained largely static over the On the other hand, innovation in the US and the
past 15 years. However, the mix has some features is taking place at an trend among
manufacturers
changed. Engine-related failures have increasing rate, such as advanced and was to attempt
decreased and safety-related failures intelligent braking systems, electronic to push recall
have increased. management systems, development liability down to
suppliers.
T his is possibly due, to of hybrids and other means of fuel
a large extent, to the fact that saving. Innovation is a risky business Right: In 1990
high levels of the
during the past two decades society at the best of times but competitive toxic substance
has become increasingly intolerant pressure for shortening innovation benzene were
o f s a f e t y - re l at e d d e f i c i e n c i e s cycles increases risk significantly. discovered in
bottles of Perrier.
no matter how rare. People have Not long ago it took an average Within a week
also become more litigious, especially of five years to develop a new model the company
withdrew 160
when encouraged by ambulance- of a car and the amount of serious million bottles
chasing lawyers. The relative number innovation in the major assemblies and worldwide.
thecqi.org | 29
A long list
Due to the high-profile publicity,
many people associate product
recalls with the automotive industry,
but if youre not in that industry
be warned: there is no cause for
complacency. The problem of recalls
is just as prevalent in other high-volume Honda and Ito
industries, such as pharmaceutical, Taiwans Taipei Times recently reported
consumer electrics, food, textiles, that Honda cut profit forecasts for
and aerospace. If you think a product the second time in as many quarters
recall is unlikely where you work, last month following recalls tied
try following the Trading Standards to the flawed Takata Corp airbags,
Institutes advice recall list on its and the new hybrid systems in its
website (tradingstandards.gov.uk/ best-selling Fit compact car and Vezel Takanobu Ito
advice/advice-recall-list.cfm). There sports utility vehicle. Hondas worst
are always 20 cases listed, many quality issues in decades have derailed
involving some of the most reputable plans to introduce new models, leading
companies in the UK. Chief Executive Takanobu Ito (right)
to first take a pay cut and, in the The forecast
end, step down. It also triggered the So, knowing the risks, what conclusions can the quality
projection of Hondas first profit drop profession draw from these trends in terms of planning
in three years. for the future?
Beset by the biggest quality problems
under his stewardship (Honda recalled P roduct recall is a growing problem across all
5.4 million vehicles last year), Ito, high-volume industries and will increase as products
61, had promised to bring Honda become more complex and innovative.
back to basics and signaled that the
ver the years company would no longer pursue The need for reliability-related concepts to be included
there have been many high-profile business expansion as its main target. in quality training courses will increase dramatically
product recalls that had devastating He said Honda had no intention of as quality professionals demand more knowledge
results. In 1990 there was the rescuing Takata financially and would of this area.
heavily publicised case of chemical work with the company to identify the
contamination of Perrier Water root cause for the airbag flaws in order M anufacturers will increasingly attempt to push
which almost caused the company to end the crisis. responsibility for product recalls down the supply chain.
to change its name. The same was While the Takata recalls affected at
the case with Farleys Rusks. In 1997 least nine other automakers, scrutiny As the risks related to product recall become greater,
Daimler-Benz narrowly avoided of how Honda responded to the flaws the reliance on third party certification will inevitably
a complete disaster when its new led to the US Government slapping switch towards greater reliance on second party auditing,
Mercedes A-Class, or Baby Benz, the company with a record $70m fine more careful supply chain management and preferred
car was found to be so unstable that it for failing to report more than 1,700 supplier schemes.
was capable of rolling over in relatively death and injury incidents to regulators
foreseeable conditions. over 11 years. And Hondas quality David Hutchins, FCQI CQP, is Chairman of David
However, the problem is not problems go beyond the defective Hutchins International Quality College Limited
just restricted to the American and airbags. The automaker called back the
European auto manufacturers. Fit its top-selling model five times
since its introduction in late 2013, and
recalled the Vezel three times. Those Read it
fixes delayed the roll-out of other What can your organisation do to protect itself?
new vehicles by as long as six months. Dont miss Davids top tips in our new Knowledge
email, coming soon to CQI and IRCA members.
The costs were clear.
COST OF QUALITY
How much do we spend to get it right?
And how much does it cost when things go wrong?
thecqi.org | 33
ACHIEVING
OPERATIONAL
EXCELLENCE
Paul Callaghan, Products Director at Gael Ltd,
explains why compliance-oriented information
management is the key to high performance
O overwhelming challenge of
maintaining and monitoring
many business systems that serve
several different purposes. Yet all contain vital
too little time
Organisations typically use several management
systems to cope with vital operational and
logistical components of the business. These
operational data that, if harnessed correctly, systems contain mission critical data.
can be put to work to drive compliance, safety, A failure in any of these systems could lead
productivity and high performance. to the following undesirable circumstances:
In an increasingly regulated world where Regulatory noncompliance and exposure
a brand can be tarnished by an unanticipated Safety failure
event, and where incremental performance An incident
improvements deliver disproportionate gains Poor operational performance
to the bottomline, a risk-based information Financial losses
management system for compliance, safety and Reputational damage.
high performance makes all the difference.
Organisations must ensure that information It is clear that scattered and isolated
collated from multiple systems is monitored information hampers operating efficiency and
and managed effectively. This is often achieved effectiveness. Managers and operatives need
through laborious processes that, in highly to be able to put their hands, immediately,
regulated and pressurised industries, can become on essential information when and where
stressful and slow. they need it.
Information scattered across these systems
can represent both an opportunity and a threat. Risk-based information
The opportunity lies in getting a grip on the Excellent organisations have achieved this by
data, improving operating performance and using risk-based information management
increasing compliance and safety. The threat, solutions. Others struggle because:
if not addressed effectively, is the fragmentation Often similar information is located in different
of data and systems that can lead to operational places with minor variations
and compliance blind spots. Documents and systems contain references and
Organisations that Organisations that seek operational sign posts, but not the sought information
seek operational excellence, high safety and compliance must find It can lead to missed opportunities, low
the means to bring systems together, get a grip performance and danger.
excellence, high safety on the information and reporting, and make it
and compliance, easier for themselves to remain compliant, while Demands on businesses will continue to
must find the managing and monitoring risk in real time. increase, particularly in industries moving
This article has been written to offer towards performance-based regulation. Is your
means to bring compliance and safety professionals an insight organisation in danger of being overwhelmed by
systems together into what can be done to achieve this. the volume of data you need to keep track of ?
thecqi.org | 35
Accreditation
KEEPING UP
WITH INN VATION
In the third part of our accreditation series,
UKAS Operations Director Jeff Ruddle
explains how to align accreditation with
an innovative business approach
I
nnovation is essential for success. However,
as an organisation grows it is easy to forget
that accreditation must be maintained at the
same pace. Regulations often change and
organisations expanding into new territories
have different requirements.
Rather than go back to square one and reapply
for accreditation, it often makes sense to apply for an
extension to scope. Adding a new activity, changing
an existing activity (ie a new technique or revised
standard or scheme) and adding a new location are
all instances where an extension to scope is required.
There are often varying requirements across
different sector schemes and technical areas, even
within the same industry sector. Talking to UKAS
about what is required and the associated timeframes,
in advance of applying, enables us to advise on any Where appropriate, has equipment been calibrated
specific requirements that may be relevant. This can and has the method been validated or verified with
be just as valuable to experienced organisations that reference materials?
regularly apply for extensions to scope as it can be to
the first-time applicant. How will quality control be applied to the method
As with any assessment visit, UKAS will assess on an ongoing basis?
the implementation of the required policies and
procedures, not the intention to do so or theory New locations have their own set of considerations,
behind it. The activity should be up and running Adding a such as if the facilities are suitable for the
and included within the management system so the new activity, application, how the new location is being managed
organisation is in a position to be assessed at the time by head office and how the new location, and
of applying. The extension to scope application (AC)
changing its staff, are operating with the organisations
forms offer useful guidance as to what supporting an existing management system.
documentation or information is needed. activity and By considering all of the above and providing the
The AC forms also give an outline of the key necessary supporting evidence, it is likely that a large
areas UKAS will examine during the assessment
adding a volume of documentation will be accumulated by
process. These include whether the new activity has new location the time of application.
been adequately and clearly documented with the are all To make sure the application is assessed efficiently
management system, and whether staff have been it is important that the application itself is clear and
trained and are able to show competence.
instances all supporting documentation is properly cross-
Questions will be raised about how the new where an referenced. An unclear application leaves room
activity has been designed and developed to extension for misinterpretation so it is important to state the
determine its fitness for purpose, and if potential specific standards, schemes, versions, methods, and
impacts on independence and impartiality have been
to scope is equipment that an applicant wishes to appear on its
considered. Those questions might include: required accreditation schedule.
For more
information:
Is quality running
ng ring
rings around
nd yo
your business?
How good is your business
bu management
ge system? T: +44 (0)23 9284 2991
Is it delivering your performance, compliance and risk objectives? E: pbs-studentrecruitment@
Are you ready for ISO 9001:2015? port.ac.uk
W: www.port.ac.uk/
FREE INITIAL CONSULTATION sqmdl
enquiries@Qfactorial.co.uk Tel: +44 1256 814111
www.Qfactorial.co.uk Mobile: +44 7442 506676
offering
All CQI Course Units
for
www.qmt.co.uk
T
This book Making Your Work
introduces
the reader to
the key issues
M Work delivers its
message via the
working activities
of sustainability and of a person called Ann.
suggests how to apply the The book is 80% theory
concepts in practice. in a global context, before and 20% Anns story.
Going beyond critically evaluating The diagrams are basic quality tools, like the
conventional theories, sustainable practice. excellent, with some very plan, do, check, act (PDCA)
it discusses issues such The final part looks informative illustrations, cycle was very useful.
as population,consumption at providing solutions but unfortunately the same Although I did get a bit
and economic growth, and recognising that ones were repeated many bogged down in the middle
with a view to adopting sustainability is not always times throughout the book. of the book.
cradle-to-cradle and easy to implement. One of the most The umbrella diagram in
circular economy The relatively new repeated examples was Chapter 9, with the heading
frameworks. A discipline of human W Edwards Demings Three roles of leaders,
familiar style is resource management System of Profound combined five tools and
adopted throughout. (HRM), at least in terms Knowledge a diagram five shared principles and
Each chapter includes of sustainability, is that does not, in fact, concepts putting these
cases studies, discussion discussed touching portray a great deal of diagrams into context.
questions and end-of- on green jobs and knowledge. The practice The methods described
chapter summaries, along eco-entrepreneurship. of including the same were implemented with
with suggested further I definitely recommend diagram many times, in a very people-focused
reading. This works well, this book to any student this type of textbook, approach, which is a factor
providing an accessible or business professional seems to be a modern often missing from both
and engaging read. as an introduction to the trend, but I find it textbooks and practice.
Kopnina and Blewitt subject of sustainability unnecessary and disruptive.
take the reader on a logical in a business context. I did find the methods Tom Rose, MCQI CQP,
and clear course, beginning used to achieve process Process Improvement
with the concepts and tools Gordon McNeil, ACQI, improvement valuable and Researcher, High
of sustainability, followed Quality Manager the practicable approach to Technology Specification
by explanations of business at AWE the use of some of our most Malvern
Review it
If you would like to be a reviewer email editorial@thecqi.org to find out whats involved.
We value your views and welcome suggestions on books you would like to see in QW.
Programme:
Repositioning the quality profession
David Armstrong, CQI Head of Profession
DEPUTY CERTIFICATION
SCHEME MANAGER
Package of 35,000 - 45,000 depending on experience
The Steel Construction Certification Scheme (SCCS) is the Certification Body specifically for companies engaged
in the design, manufacture and installation of structural steelwork and its associated products and services.
SCCS is a wholly owned subsidiary of the British Constructional Steelwork Association Ltd (BCSA).
www.steelconstruction.org
Quality Manager
(Manager, Management)
South East England
40,000 + Benets
Quality Engineer/
Quality Assurance Technician
Manager International
Yorkshire and Humber Competitive salary
Circa 60k pa plus car, bonus
and benets
8KJEAD69
C^Z]ORg]c`1DQ][^ZSbSg]c`
X]PaSSYS`^`]ZSO\RW\Q`SOaSg]c`
QVO\QSa]TPSW\UT]c\RT]`g]c`
^S`TSQbX]P<]\SSRb]U]bV`]cUV
Vc\R`SRa]TX]PORaXcabZZW\g]c`
^`]ZSO\RZSbS[^Z]gS`aR]bVSe]`Y
G:8GJ>I>C<CDL/
www.thecqi.org
www.thecqi.org
H^\cjeidFjVa^in?dWhidYVnqlll#fjVa^in_dWh#dg\#j` | |
QW APRIL 2012
QW SEPTEMBER 2012 |3
Our open courses are available in London,
Birmingham, Germany, Turkey and the Middle East
Public Lean Six Sigma training from PMI & the CQI
Green Belt qualified elsewhere? Want to make the move to Black Belt? Price: FREE
Become eligible to complete a PMI CQI Black Belt Conversion course by taking a series
of FREE preparation modules all included in the price of our conversion course.
PMI is a preferred supplier to the Career Transitions Partnership (CTP), the official
provider of Armed Forces Resettlement. A discount is available on published prices.
All prices exclude VAT. CQI members also qualify for a 5% discount on prices.
Process Management
Process Design and Improvement 2 1617 625 750
Quality Tools
Root Cause Analysis 2 2122 625 750
Tools and Techniques for Performance Improvement 2 2324 625 750
Cost of Quality 1 20 355 425
Improvement and Change Courses start throughout the year. See left page for course details
Lean Six Sigma
Auditing
Internal Auditing of Quality Management Systems 2 301 2829 2526 625 750
These dates may change, please visit the CQI website for up-to-date information thecqi.org/Training/Public-training-courses
Steve Warwood, FCQI CQP, Chair of the CQI Advisory Council and
Advanced Quality Planning Manager at Morgan Advanced Materials
The Advisory Councils areas of the quality
(AC) primary duties community such as
are to elect and maintain the financial and
an effective governing public sector.
body (the CQI Board
of Trustees), act as The biggest challenge
a consultative body and facing the profession
ensure the interests is making sure quality
of the profession and is still on the business
its stakeholders. agenda in 10, 20 and
30 years time. Our main
The AC is constantly priority is to harness the
recycling its membership, creativity and potential
making it a dynamic and of the next generation
challenging body. Its of quality professionals.
my privilege to support
this group of diverse The quality professional
quality professionals to of the future looks like
make sure we represent you and me but with
the views of the CQIs the vital ingredients
membership. of good governance,
agile assurance,
Im planning to take the evaluation and
AC forward to ensure improvement.
it is adding value to
the CQIs vision and Quality can teach
strategic objectives for business a lot.
the profession. W Edwards Deming
once said it all in
With more than 30 years three simple words:
experience in the quality People make quality.
arena, I bring a wealth
of knowledge to the role. Theres no greater
Ive previously held chair feeling than when you
positions in industry and see people get quality
academia, and Im used be it on the shop floor
to acting as a gladiator of or in the training room
our profession fending and customers tell
off the lions. you about it.
@QUALITYWORLD
WHEREVER YOU ARE, KEEP UP TO
DATE WITH THE LATEST QUALITY
NEWS, INCLUDING A DAILY
NEWSPAPER ROUND-UP