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CONTINUAL IMPROVEMENT:
ALIGNING LEAN WITH ISO 17025 CLAUSES
TO IMPROVE LABORATORY EFFICIENCY
NLA Test and Measurement Conference
12 - 14 October 2015
The Lord Charles, Somerset West, Cape Town
Odette Makobe: Masters in Quality
Department of Operations and Quality Management
Dr Bloodless Dzwairo (Supervisor)
Presentation Outline
• Background
• ISO 17025
• Lean
• Internal Audits and Gemba
• Conclusions
• Acknowledgements
NLA Test and Measurement Conference
12 - 14 October 2015
Background
• International standards were developed to eliminate barriers to trade as well as provide confidence to buyers.
• But, compliance to international standards does not necessarily guarantee business success.
• The benefits of a quality management system should go beyond compliance but reflect the elements of continual improvement within business systems and processes (Bortolotti, Boscari, & Danese,2015) .
NLA Test and Measurement Conference
12 - 14 October 2015
ISO 17025
• The international standard ISO 17025 serves as a guideline to which laboratories must demonstrate compliance in order to be granted the accreditation.
• The accreditation provides formal recognition to competent laboratories, thus providing a ready means for customers to identify and select reliable testing, measurement and calibration services.
NLA Test and Measurement Conference
12 - 14 October 2015
Contd.
• Over the years, more and more laboratories have achieved
accreditation status (sanas.co.za, 2015) .
• The current economic conditions also challenges organisations to
seek new ways to improve profits while reducing costs.
• Thus, to be sustainable, laboratories can no longer only rely on
their accreditation status as the sole competitive business tool.
NLA Test and Measurement Conference
12 - 14 October 2015
LEAN
• Developed in the 1950’s in a company that is today called
Toyota Motor Corporation.
• It’s regarded as having strategic tools to successfully reduce
costs, eliminate waste, increase efficiency, and maintain high
levels of quality whilst managing to make a profit (Karim 2013)
NLA Test and Measurement Conference
12 - 14 October 2015
Contd.
• The ultimate goal of implementing lean is to achieve
organisational efficiency and greater productivity while
providing quality services at lower cost (Holtskog 2013).
• By focusing only on what's of value to the customer, more value
is achieved from existing resources with lesser additional costs
(Bhasin 2012).
NLA Test and Measurement Conference
12 - 14 October 2015
Contd.
NLA Test and Measurement Conference
12 - 14 October 2015
Tools ISO 17025 clauses
Visual Management
4.2
Management System
Value stream Mapping
4.7
Service to the customer
Standard work
5.9
Assuring the quality of results
Gemba
4.14; 4.2
Internal Audits; Management System
Kanban
4.6
Purchasing service and supplies
5S
5.3
Accommodation and Environmental
conditions
Kaizen
4.10; 4.11; 4.12
Improvement, Corrective Action,
Preventive Action
Internal Audits
NLA Test and Measurement Conference
12 - 14 October 2015
Gemba
4.14; 4.2
Internal Audits; Management System
ISO 17025 states:
4.14.1 The laboratory shall periodically, and in accordance with a predetermined schedule and
procedure, conduct internal audits of its activities to verify that its operations continue to comply with the
requirements of the management system and this International Standard
4.14.2 When audit findings cast doubt on the effectiveness of the operations or on the correctness or
validity of the laboratory's test or calibration results, the laboratory shall take timely corrective action, and
shall notify customers in writing if investigations show that the laboratory results may have been affected.
Contd.
NLA Test and Measurement Conference
12 - 14 October 2015
• Audit schedules can be organised as horizontal or vertical.
• A vertical audit checks compliance of, for example, a single test
through all steps from sampling to archiving of records.
• A horizontal audit examines every aspect of a single requirement.
Contd.
Internal audits are planned to establish that : • Management objectives as defined in the quality system are
met in all aspects.
• All personnel at all levels, are satisfactorily carrying out their assigned duties and responsibilities.
• The procedures detailed in the quality management system are being followed.
NLA Test and Measurement Conference
12 - 14 October 2015
Gemba
• GEMBA is a Japanese term meaning the "real place”
• It is often referred to as the place where value added activities
occur.
• The Gemba Walk is a concept that was created by Taichii
Ohno, one the founders of the Toyota Production System.
NLA Test and Measurement Conference
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Contd. • It is based on three principles:
Go to the real place
Ask Questions
Show respect
NLA Test and Measurement Conference
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Contd. • The concept refers to the activity in which management goes to
the front line to identify waste and practice practical shop floor
improvement.
NLA Test and Measurement Conference
12 - 14 October 2015
Contd.
• It upholds the concept that to fully understand an issue, one
must visit the work site and observe the impact of what is
happening.
• Only then, through learning on the front line, can appropriate
interventions be made.
NLA Test and Measurement Conference
12 - 14 October 2015
Contd.
• Gemba supports the modern business philosophy of continuous improvement.
• While the internal auditor verifies compliance,
the gemba walker teaches “learning to see” and identify waste.
• Thus encourages and empowers top management and
employees to work together to recognise the inefficiencies and
gaps in a process or system.
NLA Test and Measurement Conference
12 - 14 October 2015
Contd.
NLA Test and Measurement Conference
12 - 14 October 2015
Quality Management and Training: 5 Whys (Five Whys) Gemba Gembutsu
Conclusion
• Internal Audits are a requirement of ISO 17025
• They ensure that all the components of the system itself are
monitored and that not only is the standard maintained but that
the system is gradually improved.
• Gemba walks encourages top management to continually
witnesses and monitors overall performance at the “real place”.
NLA Test and Measurement Conference
12 - 14 October 2015
Contd.
Gemba walks:
• Create a culture of continuous improvement (involvement of all staff)
• Identify training needs, ensures procedures are followed,
standardisation routines are observed, all checks are done, and records properly kept.
• Highlight top management commitment towards continual improvement of the management system.
NLA Test and Measurement Conference
12 - 14 October 2015
Contd.
• Many pain points in a process can be identified just by listening
to those who work with the process on a daily basis.
• Facilitates top management’s engagement with those that do
the work and emphasise the importance of the work that they
do towards the success of the business.
• Emphasises the fact that quality is a shared responsibility.
NLA Test and Measurement Conference
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References • Bhasin, S. 2012. Performance of lean in large organisations. Journal of Manufacturing
systems, 31(3): 349-357.
• Bortolotti, t., Boscari, S., & Danese, P. 2015. Successful lean implementation: organizational
culture and soft lean practices. International Journal of Production Economics, 160(0):
182-201.
• Holtskog, h. 2013. Continuous improvement beyond the lean understanding. Procedia CIRP,
7(0): 575-579.
• Karim, a., & Arif‐uz‐zaman, K. 2013. A methodology for effective implementation of lean
strategies and its performance evaluation in manufacturing organizations. Business Process
Management Journal, 19(1): 169-196.
• Skeldon, s. C., Simmons, A., Hersey, K., Finelli, A., Jewett, M. A., Zlotta, A. R., & Fleshner, N.
E. 2014. Lean methodology improves efficiency in outpatient academic uro-oncology clinics.
Urology, 83(5): 992-998.
• sanas.co.za, (2015). Directory of accredited facilities | South African National Accreditation System.
http://home.Sanas.Co.Za [accessed 09 August 2015].