This document discusses developing and sustaining a quality culture within an organization. It outlines a three-part test for quality culture, which includes leadership prioritizing quality, clear communication of quality messages, and empowering employees. It then assesses different aspects of quality culture, such as governance structures, compliance activities, metrics, leadership, human resources practices, training, rewards, and information sharing. Finally, it outlines what a high-performing, sustainable quality culture could look like, including employees understanding their quality roles, leadership engagement, communication, training, consistent standards, and institutionalizing lessons learned.

1. By Swapnil Karale
Founder(STAC Skills Center),
GMP/EHS/TQM Expert, Corporate Trainer,
Qualified GMP/EHS Auditor, Mentor
DEVELOPING AND SUSTAINING A
QUALITY CULTURE
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4. Can we pass this three-part test?
 Do our company leaders not only stress the
importance of delivering a quality product, but
reflect that mantra in their own day-to-day job
functions?
 Does our organization clearly communicate
quality-focused messages that our employees
take to heart?
 Does our company encourage peer involvement
in quality efforts and empower its employees to
initiate change for the sake of quality
improvement?
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5. Quality Culture Assessment
 Quality/compliance governance
structures:
Are there effective mechanisms for such activities
as global change management for new product
introductions, processes for regulatory changes,
pharmacovigilance, product complaints, quality
related councils, and management review boards?
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6. Quality Culture Assessment
 cGMP compliance activities
These include batch/lot issuance, batch review and
disposition, deviation management, corrective and
preventive action, change control, document
control, internal auditing/inspection, risk
identification/remediation, annual product review
and all of the other relevant processes and
procedures. Are they uniform, compliant, and
effective at each site, across sites, and across the
entire organization?
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7. Quality Culture Assessment
 Quality metrics
These include such measures as right first time,
cycle time, product complaints, regulatory events,
action plan attainment, reportable events, and the
like. Quality metrics should be appropriate and
provide the basis for effective review of quality
performance.
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8. Quality Culture Assessment
 Leadership styles and behaviours:
Do leaders take a comprehensive view of quality,
communicate that vision effectively throughout the
company, and behave in ways that foster and
support the efforts of all employees?
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9. Quality Culture Assessment
 Human-resource practices:
Are personnel sourced, recruited, hired, and on-
boarded in ways that promote a consistent, high-
performing quality culture? This can be an even
more challenging issue with temporary employees,
who may have little long-term allegiance to the
company or exposure to the company's values in
regard to quality.
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10. Quality Culture Assessment
 Learning and personal development
systems:
How broad, deep and effective is the organization's
training program? Are personnel given
opportunities for further professional development?
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11. Quality Culture Assessment
 Quality behaviour reinforcing
mechanisms:
Are performance management policies, rewards,
and recognition designed to motivate individual
employees as well as teams to consistently strive
for quality?
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12. Quality Culture Assessment
 Quality-related information systems:
These include not only IT and enterprise resource
planning systems used for document management,
deviation management, change control, and the
like, but also the way in which information is
shared. Are best practices and lessons learned at
one site communicated to the other sites within the
company to maintain a uniform, high-quality
company culture?
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13. Quality Culture Assessment
 Employees' perceptions in relation to
quality at the company:
How do employees react to statements that
describe the cultural norms and behaviors of a high
performance organization with a strong quality
culture?
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14. My Dream of Quality Culture…..!
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15. What should the resulting high performing,
sustainable quality culture look like?
 Employees at all levels understand the
organization's quality objectives, policies, and
procedures and their individual roles in helping to
achieve them.
 Leadership at all levels is visibly engaged in
supporting the development of a quality culture
and effectively engages and motivates others to
do the same—leading to self-motivated
accountability and sustainability.
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16. What should the resulting high performing,
sustainable quality culture look like?
 Effective communication, enterprise-wide sharing
of best practices, engagement of all employees,
and rewards and recognition for both teams and
individuals maintain the momentum and
enthusiasm required for sustainability.
 The organization hires people who possess the
quality values, norms and work practices the
company desires.
 Technical and quality training are deployed at the
company, business unit, functional area, and
individual levels.
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17. What should the resulting high performing,
sustainable quality culture look like?
 Consistent and sustainable standards of quality
are defined clearly and deployed across the
organization in conjunction with quality and
compliance systems that enable the organization
to achieve those standards.
 The organization distinguishes between people
and processes as the root cause of mistakes, and
instead of blaming people looks to correct
processes.
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18. What should the resulting high performing,
sustainable quality culture look like?
 Leaders and managers at all levels establish an
environment of trust and collaboration in which
challenging issues can be raised without fear of
reprisal.
 The organization institutionalizes a process for
capturing, analyzing, and incorporating lessons
learned from past successes and failures.
 As the organization grows and changes, the
quality culture is continually monitored and fine-
tuned to ensure that it remains effective and
sustainable.
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19. What are other remedies to instil a
sustainable Quality Culture in our
Organization??
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20. The journey from quality culture assessment to
transformation to sustainability need not take
long or consume massive resources. But it does
require the recognition that achieving quality and
compliance is not a matter of a discrete, isolated
process but of the larger environment in which it
takes place…!!
Conclusion
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22. Thank You..!
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