Global quality trends report 2019

Global insights, challenges and

experiences from 250+ quality professionals

Our software reduces compliance burden associated with regulations and

standards:
The state of quality
management in 2019

29% 23% 59%

spend more than 7
days a month were promoted in feel overworked
compiling reports the past 12 months

44% 50% 79%

have a budget are effectively using
technology to
believe the quality
management system is
address quality becoming the business
management management system
initiatives

46% 50% 80%

are members of a feel they don't have the believe electronic data
professional body tools they need analysis will become integral
to the modern QMS
 Contents
1.0 Welcome 4
Introduction to the 2019 quality trends report

2.0 Executive summary 5

Key findings

3.0 The report 6

The quality industry in 2019

4.0 Lessons learned and opportunities 18

What's on the horizon for 2019

5.0 Methodology 20
How we collected the results

3.
 1. Welcome to the global quality
trends report 2019
Kate Armitage
Head of Quality Assurance
kate.armitage@qualsys.co.uk
The 2019 global quality trends
report has been collected by
Qualsys to understand how the
quality profession has evolved
over the past 12 months.
We asked 265 quality
professionals from 55 countries
about their experiences, working
styles and day-to-day challenges.
This report gathers their
responses together.
From lessons learnt to the role of
technology and new ISO
standards, the 2019 report
unpicks which factors are
impacting the quality role, how
quality professionals are
spending their time, and what the
key priorities for 2019 are.
We hope you find the report
useful and insightful.
 2. Executive summary
Key findings from the 2019 report

There's plenty to celebrate in this year's report.

Business leaders are more engaged than ever with quality.
More quality professionals than ever have been promoted.
Internal audits are working and quality teams are bursting
with ideas and opportunities.
But some consistent problems - risk-based thinking, access to
tools, manual timesinks - remain.
Annex SL's emphasis on managerial commitment to quality
continues to bear fruit. From 67% in 2017 and 40% last year,
now just 19% of surveyed quality professionals feel that
leadership aren't sufficiently engaged with the quality agenda.
Respondents were generally happy with their level of internal
authority, and 68% have confidence that risks and
opportunities are being effectively uncovered and dealt with by
their auditing programmes.
Yet quality professionals are still struggling to embed
business-wide engagement as part of a 'culture of quality'.
Disjointed paper-based processes and underinvestment
continue to be key roadblocks, and because of this less than a
third of respondents rated their QMS as highly mature.
How a newly engaged layer of senior management addresses
these issues remains to be seen.

5.
 Where quality professionals spend their time
What do quality professionals consider to be
With 59% of respondents feeling overworked and 50%
thelacking
most access
important part
to the full ofoftheir
range tools they need, how
organisational input?
quality professionals prioritise and invest their time is
becoming increasingly significant.
Managing document versions, boosting process efficiencies,
saving time and ensuring equipment and assets are safe
ranked highest in quality priorities.
Closing out CAPA actions on time and maintaining
certification ranked the lowest.

How important do you consider...

Managing document versions?

Process efficiencies and time saving?

Ensuring equipment/assets are safe?

Reporting compliance status/metrics?

uk
Embedding a culture of quality?

Preparing for external audits?

Building measurable KPIs?

Maintaining certification at all costs?

Closing out CAPA actions on time?

6.
 Health and safety is the top certification priority

75% of respondents are already accredited to ISO 9001, with

another 14% aiming for certification in the next 1-3 years.
ISO 14001 and ISO 27001 are the next most popular standards.
And ISO 45001, the health and safety replacement of OHSAS
18001, is the top priority for the next 3 years, with 40% placing
the standard on their radar for certification.
Industry-specific standards such as ISO 22000 and ISO 17025
also ranked highly, as did energy (ISO 50001) and business
continuity (ISO 22301) priorities.

7.
 Manual and paper-based reporting continue to waste time
A large majority of working time is still spent compiling reports.
44% said they spend five or more days a month on reporting, a
4.5% increase on last year.
This correlates with a high reliance on paper-based systems:
43% of respondents manage their audits and CAPA plans
solely on paper, and 14% of quality manuals are purely paper-
based.

"The most challenging part of my role is paperwork and

paper records overload."
- Survey respondent

8.
QMS maturity

Only 29% rated the maturity of their quality management

systems as 'high'.
This is the third consecutive annual decrease, suggesting an
increasing gulf between quality management systems and
industry demands.
Perhaps in response to this, 29% of respondents managed an
electronic quality management system implementation within
the past 2 years.

9.
 80% think a culture of quality is important for their
organisation
39% of respondents felt that a genuine culture of quality was
important for their business, and 41% felt it was very important.
At the same time, only 21% felt all employees were effectively
engaged with quality and only 23% felt staff were effectively
trained in quality management initiatives.
So although the importance of a quality culture is widely
accepted, most quality professionals feel there's still a long way
to go for their businesses.

"What I think and what operations commit to are miles

apart."
- Survey respondent

Access culture of quality resources

10.
 Managerial commitment to quality continues to increase
Most quality professionals have at least some confidence in
their managerial commitment to quality management
initiatives, as per the requirements of Clause 5.1 of Annex SL.
37% believed their management were very or extremely
effective at demonstrating quality commitment, while 52% felt
they were moderately or slightly effective.
Only 8% believed management were not at all effective at
meeting the requirements of Clause 5.1.
19% felt they didn't have the necessary engagement from senior
management to drive the quality agenda - a dramatic decrease
from 40% and 67% in 2018 and 2017.

Risk-based thinking isn't sufficiently ingrained

Risk received a more lukewarm reception.
37% believed their organisations were moderately effective at
proactively managing risks and employing 'risk-based thinking'.
But 39% felt they were only slightly effective, or not effective at
all. Only 5% had full confidence in their organisation's risk
effectiveness.

Smaller quality departments

Although 49% of respondents reported a growth in the size of
their organisation in the past year, only 27% reported growth in
their quality department. 57% of quality departments remained
the same size while 16% shrank.
This decrease in the proportional size of the quality team
correlates with the perceived decrease in QMS maturity
reported by respondents.

11.
 Authority but not resources

"I have the level of authority to implement required changes."

"I have the necessary engagement and support from senior

management."

12.
 "I have the tools I need."

"I have the resources I need."

13.
 Challenges of the quality role
Quality professionals are most likely to leave a role because of
a lack of authority, and 28% of respondents said they had
done so at least once.
Resource was the second-strongest bugbear, with 27%
admitting to leaving a role because of insufficient resources.
Access to tools was the third main challenge, with 19% leaving
a post because of an inadequate set of quality management
tools and tech.
42% felt that technology was becoming increasingly important
for the quality role. 2/3 of respondents agreed that tablets and
smartphones would become increasingly useful, while 80% felt
that electronic quality data analysis will become integral for
the modern QMS.
With only 44% of respondents enjoying access to a budget,
underinvestment in tools and resources continues to be a
source of
uk
dissatisfaction in the quality profession.
Other common challenges included:

"Creating a system with

data and accountability"
"Standardisation across
sites and teams"
"Time"
"Mundane, operational
and transactional tasks"
"Motivating others to do
their bit of the QMS"
"Not knowing what
technology is out there to
help the business"
"Keeping records and
tracking processes"
"Communication across
the business"

14.
Management system auditing

Future plans and opportunities

ISO 19011:2018 has been adopted fairly widely for a relatively

new standard version, with 34% of respondents already
working to its requirements.
The impact of the standard on organisational approach to
auditing was widely recognised. Comments included:

"We have a more effective

approach to building and
monitoring our internal
audit activities" "We are much more risk-based
and link our auditing to the
broader business perspective"
"We have more effective
planning and accuracy to build
upon for future audits"
"We concentrate on areas that
need auditing rather than
working to a fixed schedule"

15.
 Auditing methods: capturing data and findings

Paper Electronic checklist Other

For the first time, electronic auditing has overtaken paper checklists
as the time and resource advantages of electronic checklists are
invested in.
8% of respondents used a combination of paper and electronic,
including other tools such as SharePoint and Microsoft Word.

Auditing methods: managing post-audit CAPAs

Paper Electronic Process maps/ Electronic

instructions instructions flow charts/ quality
in a Visio system
shared folder workflows

16.
 A fifth of respondents used a workflow within an electronic
quality system to manage their CAPAs. Although a quarter
still relied on paper, 41% used shared folders in Office or
SharePoint, or circulated CAPA plans by email.
Respondents using electronic methods reported higher
efficiency than those on paper alone, with EQMS workflows
scoring highly for collaboration and team alignment.

The state of auditing

Most surveyed quality professionals had confidence in their
internal auditing processes.
65% of respondents agreed that their leadership teams were
supporting internal auditing as part of good governance.
68% felt that their auditing programme was effectively
identifying risks and opportunities for their business.
And 61% felt identified CAPAs were being properly managed
post-audit.
But only 38% felt their supply chains were being thoroughly
and regularly audited, and - perhaps in connection - only
35% felt that revenue or return on investment was being
generated by auditing.
This suggests that supplier management will (or at least
should) become an increasingly prominent focus for auditors
in 2019.

"My biggest auditing challenge is embedding lasting change,

rather than just fixing the immediate issue."
- Survey respondent

17.
4. Lessons learned in the past year
"Quality
professionals need
more focus on "ISO is often seen as a shiny stamp
stakeholders." by management."
"Having a strong procedure manual is the
cornerstone of QMS implementation."

"Move away from paper-based systems as soon

as practicably possible."
"Quality assurance is no longer driven
centrally. Only organisations that can sustain
"I realised the quality as a way of doing business every day
strength of will survive."
corporate culture
in resisting change." "Don't
depend on "Never take your eye off
the ball. A good project
people alone can go bad at the drop of
as drivers." a hat."
"Prioritisation "QMS maturity can vary across an
is organisation."
key."
"Some things, like
Brexit, are outside our
"Don't stress about audits." control."
"You can't do it all
"You can be on the right path and just
need some extra tools and tech to push on your own."
you forward."
Plans and opportunities for 2019
"Use our certification to
springboard us ahead of our
competitors."
"Implementing our electronic quality
management system modules and
embedding the system into the
company culture."
"Reducing our
reliance on paperwork."
"Calculating the real ROI of quality to
strengthen our profile in the
boardroom."
"New standards."
"To fully implement in the organisation
an EQMS and engage all staff in it."
"Converting all turtle process diagrams
to flow maps, introducing a new
internal audit program and adding
new organisational KPIs."
"Communication plan for employee
engagement."
"Standardising our QMS across sites,
maybe electronically."
"Digitisation of company records and
live data capture from manufacturing."

"Data privacy framework and ERM."

"Build a more circular economy with

our management systems."
 5. Methodology
Process for collecting the responses

The 2019 Global Quality Trends Survey was drafted by

Qualsys in January 2019 and distributed to over 16,000
governance, risk and compliance professionals worldwide.
The survey produced 265 respondents. 41% of respondents
were quality and compliance managers, 10% were
consultants, 9% were directors or CEOs, and 6% were
process managers and engineers. The rest held a mixture of
project manager, auditor, advisor, analyst or other specialist
roles.
22% have held their roles for over ten years, 14% for 6-10
years, 35% for 2- 5 years, and 29% for 2 years or less.
The survey went out to a wide range of industries.
The largest represented industry group was manufacturing
with 51%. Healthcare and pharmaceuticals was the second-
largest group with 23%. Next was oil, gas and power with a
9% share, financial with 5%, government and outsourcing at
4% each, telecommunications at 2%, and aerospace and
media with 1% each.

20.
 What do you think of the
results this year?
Tweet us @QualsysEQMS to
share your thoughts on the
survey findings.

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