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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


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) .


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.


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.


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)


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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).


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Contd.

Lean tools:


12 - 14 October 2015

Contd.


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


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.


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.


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.


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Contd. • It is based on three principles:

Go to the real place

Ask Questions

Show respect


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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.


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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.


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Contd.


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.


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Contd.


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”.


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.


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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.


12 - 14 October 2015

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].

Acknowledgements

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