Bringing new perspectives on the approaches, methodologies, tools and technologies, which organizations can use to bring about improvements in their operations. The perspective isolates the issues and finds solutions, and is a catalyst for specific changes to technologies, processes, job roles or organization structures. With this systemic approach and improvements in QMS, an organization makes a difference to the customer and provides a lasting effect. Main points covered: • How organizations can use new perspectives to bring about improvements • In which ways this systemic approach makes a difference • How perspectives isolate issues and find solutions Presenter: This webinar was presented by PECB Certified Trainer and Managing Director of MMCAFRICA Mr. George Ogoti. Link of the recorded session published on YouTube: https://youtu.be/vQ2GKefNSRQ

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“Implementing a new
QMS improvement system
By George Ogoti-MMCAFRICA

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George Ogoti
Managing Director, MMCAFRICA
George Ogoti (58 years), an MSC (Chemical Engineering) holder, is an International Auditor, Trainer
and Consultant on SHEQFS and other systems . He has an excellent knowledge industry's standards
having worked for over 34 years. He is also a PECB certified auditor, trainer and implementer and
has extensive coverage in Africa and Middle East . He is an accomplished expert in SHEQFS and
shares his experience and knowledge on various topics.
721 687 406
ogoti @mmcafrica.com
www.mmcafrica.com
linkedin.com/george.ogoti
twitter.com/george.ogoti
fb.com/george.ogoti

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Chapter 1
ISO 9001:2015 Clause 10, Improvement:

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Sub-clause 10. 3 - Continual Improvement
The organization must
determine and select opportunities for improvement
and
implement any necessary actions to meet customer
requirements and enhance customer satisfaction.

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These actions include
improving products and services to meet
requirements,
address future needs and expectations;
correcting, preventing, or reducing
undesired effects;
improving the performance and
Improving the effectiveness of the QMS

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Examples include
correction,
corrective action,
continual improvement,
breakthrough change,
innovation, and
reorganization

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Summary note 1Summary note 1
Improvement actions are taken to meet customer
requirements and enhance customer satisfaction.
not only improve products and services to meet knownknown
requirements,requirements, but also to address “future” needs and“future” needs and
expectationsexpectations..

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Chapter 2: Systems you can use for improvement
Methodologies
Technologies
Tools
Approaches

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New QMS improvement approaches
These are management approaches for
isolating issues and finding solutions,
These approaches become the catalyst for
specific changes to technologies, processes,
job roles or organization structures.

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Three components for systemic approach
for improvements-
Delivery method of product or service,
Design of the product or service, and
Management system
This will make a difference to the customer
and provides a lasting effect
Let us look at the 3 improvement approaches

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2.1 Process Improvement (PCI)
 Receive requirements - sources or customers,
 Determine/review requirements -customer
needs/expectations .
 Cascade the requirements to various levels
 Translate the requirements to actionable items.
Note: process improvement methodologies are required to improveNote: process improvement methodologies are required to improve
operational efficiency and effectivenessoperational efficiency and effectiveness.

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2.2 Product Improvement (PDI)
PDI -re-engineering can remove unnecessary cost from the product
design.
identify the intent or function of the product
understand the context of the design
develop alternatives
implement the plan.
Team(s) from e.g. planning, sales, finance, manufacture, design,
customers and external providers team(s) can systematicallysystematically
examine/find how the product performs the function the customerexamine/find how the product performs the function the customer
requires and address future needs (re-engineering)requires and address future needs (re-engineering)

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2.3 Management Practices Improvement (MPI)2.3 Management Practices Improvement (MPI)
 Basis for human activities and efforts of any organization .
 Governs personnel interaction within the organization,
 Governs personal interaction between the organization and the rest
of the world.
 Based on theory, or may emerge as the organization matures.

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New systemic approach to QMS improvement
PCI + PDI + MPI
=
improving XYZ as a wholeimproving XYZ as a whole..

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USING:PCI + PDI + MPIUSING:PCI + PDI + MPI
1) Functional areas – actions can impact
other groups and the entire QMS,
2) Each group - investigate actions to
benefit the entire QMS,
3) Each group -identify the dangers of risk
introduction to the system.
4) Each group – check optimal performance
of functional area in order for the entire
system to improve.
Note 2:- the three dependent on each otherNote 2:- the three dependent on each other.

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Chapter 3: Other sub-clauses on improvement
10.2 Nonconformity and Corrective Action
10.2.1 When a nonconformity occurs, including any arising from
complaints, the organization must react to the nonconformity and,
as applicable take action to control and correct it; and deal with
the consequences.
The organization must also evaluate the need for action to eliminate
the causes of the nonconformity so it does not recur or occur
elsewhere, by reviewing and analyzing the
nonconformity, determining the causes of the nonconformity and
determining if similar nonconformities exist, or could potentially
occur.

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NON-CONFORMITY & CA CONT’D
The organization must implement any action needed and review the
effectiveness of any corrective action taken; It must update risks and
opportunities determined during planning, if necessary and make
changes to the quality management system, if necessary. The
corrective actions must be appropriate to the effects of the
nonconformities encountered.
10.2.2 The organization must “retain” documented information as
evidence of the nature of the nonconformities and any subsequent
actions taken and results of any corrective action.

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10.3 Continual Improvement
 The organization must continually improve the suitability, adequacy,
and effectiveness of the quality management system. The
organization must consider the results of analysis and evaluation,
and the outputs from management review, to determine if there are
needs or opportunities that must be addressed as part of continual
improvement.

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 The standard requires that the organization must react to a
nonconformity by first controlling and correcting it, as well as,first controlling and correcting it, as well as,
dealing with its consequences.dealing with its consequences.
 determine if similar nonconformities exist, or could potentiallydetermine if similar nonconformities exist, or could potentially
occur.occur.
 update the risks and opportunities determined during planning, if
necessary.
 make changes to the quality management system, if necessarymake changes to the quality management system, if necessary.
 Clause 10.2.2 adds that the documented information retained as
evidence indicating the nature of the nonconformity and any
subsequent actions taken.

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Issue: Feb 2013 MMCAFRICA - EMS Auditor / Lead Auditor Training Course
Chapter 4: Phases andChapter 4: Phases and
questions to consider inquestions to consider in
new QMS improvementsnew QMS improvements

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Phases Questions to consider
1. Awareness
Awareness of the need for the new improvement
system
•Why is the improvement system needed?
•What are the risks of not using this improvement
system?
•Why is this improvement system being implemented
now?
•What is the general nature of this change – what does
it mean to use Lean? or Six Sigma?
2. Desire
Desire to participate and support the new improvement
system
•What are the organizational drivers causing us to
bring this new improvement system into the
organization?
•What are my personal motivators for getting involved

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3.Knowledge
Knowledge on how to use the new improvement
system
•What will be my role in using the new
improvement system?
•What do I need to know to be successful using
the new improvement system?
•When will I be trained on how the new
improvement system works?
4.Ability
Ability to implement the skills and behaviors required
by the new improvement system
•What exactly will I be doing differently as a result of
the new system?
•When will I have a chance to practice?
•Where do I get support and assistance to be
successful as part of this new system?

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5. Reinforcement
Reinforcement to sustain the new improvement
system
•How do I know the organization is committed to
using the new improvement system?
•Is top management really committed to making
this successful?
•Will this new approach be discarded?

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Tools for continually improve, may
include:
capability studies,
design of experiments,
risk analysis,
SPC,
Six Sigma
Lean Manufacturing

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 supplier evaluation,
 test and measurement technology,
theory of constraints,
 equipment effectiveness, technology,
 benchmarking,
 analysis of motion/ergonomics and
error-proofing.

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Remarks
Ensure personnel applying these tools are
competent and trained.
Ensure performance indicators measure the
effectiveness of process continual
improvement to include quality objectives being
met sooner than planned,
Ensure business and quality objectives are
based on improved efficient use of resources,
cost reduction, improve product quality, etc.

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Situations requiring improvement projects
include:

machine set-up,

die change,

machine changeover times,

cycle time, scrap,

non value-added use of floor space,

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
variation in process parameters,

less than 100% first run capability,

process averages not centered on target
values,

testing requirements not justified by
accumulated results,

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
waste of labor and materials,

difficulty in manufacture,

difficulty in assembly and installation
of product,

excessive handling and storage, etc.

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??
QUESTIONS
721 687 406
ogoti@mmcafrica.com
www.mmcafrica.com
linkedin.com/george.ogoti
twitter.com/george.ogoti
fb.com/george.ogoti
THANK YOU