Title Pages QMS

Quality Improvement through QMS
implementation at Business Partners Works
BITS ZG629T: Dissertation
by
John Joseph J
2008HZ79621
Dissertation work carried out at
Bosch Limited, Adugodi, Bangalore – 560 030
BIRLA INSTITUTE OF TECHNOLOGY & SCIENCE
PILANI (RAJASTHAN)
October 2010
CHAPTER – 2
REVIEW OF LITERATURE
2.1 Introduction
The Literature review was done for this dissertation to compare with the previous QMS
study conducted for implementing Quality Management Systems (QMS) for a Garri4
project in National Electricity Corporation Power Plant.
2.2 Design and Implementation QMS at Power Plant

2.2.1 Outline of the Study
The study consists of four sections:
Section 1: Introduction
Section 2: QMS framework design
Section 3: Research methodology and Findings
Section 4: Analysis and Conclusions

2.2.2 Introduction
The purpose of this study (Literature review) conducted for Power Plant work is to
design, implement, and measure effectiveness of QMS in the Garri4 power plant project
in Sudan. In the second section, we extensively reviewed relevant literature, which can
be used to enhance the QMS work frame design and also to assess its effectiveness.
It has been stated that the scope of this dissertation is to analyze the QMS gap in the
existing workplace of Business Partner, bridge the gap by fixing action and make follow-
up to implement the action fixed.
The existing gap was identified through a process of exploring ISO 9001:2008 standard,
departmental procedure, CDQ documents, Books.
2.3 The PMBOK Guide

The quality management system in the PMBOK comprises of three linked parts:
1- Quality planning.
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2- Quality assurance.
3- Quality control.
As has been stated in the PMBOK, the whole QMS system is considered to be built and
implemented within one organization. However, the Garri4 situation is completely
different. The Garri4 project is owned by NEC as stated before. Therefore, the owner
role is considered to be within the quality assurance, which is the aspect of focus in this
thesis work.
A very important point should be considered here, as was stated in chapter 2, section 2.2,
the entire project management processes is aggregated into five process groups. These
are: initiating, planning, executing, monitoring and control, and closure. As, stated in the
PMBOK guide, there are 9 knowledge areas associated with these five process groups.
Quality management is one of them as is illustrated in Figure (3-1) below:
PMBOK knowledge areas

Figure (2-1)
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Project Management Process Flow diagram, Source: PMBOK (2004) pp.183
Figure (2-2)
Certainly it can be stated that quality planning is a part of the whole project planning.
This clearly shows the importance of early quality planning in the earliest project stages.
However, being that there is, there is no quality plan or even quality manual for the
Garri4 project, and the project to this point in time has completed a bit more than 60% of
its work, one can only consider the remaining erection period and the upcoming
commissioning (trial operation) phases of the complete power plant. As a result, taking
into consideration the limitation of the thesis time (up to fall 2008), the QMS will only
cover a maximum period of 3 months of the remaining erection phase, which is divided
into two finishing stages, the first one on 15th November 2008, and the second one on
15th January 2009.
As we discussed, quality as a system has inputs, processes and outputs, or outcomes,

used by the internal parts of the QMS. There is always feedback returning to the
planning part for continuous improvement purpose. The following figure simplifies the
QMS as a system:
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QMS simple flow chart
Figure (2-3)
The concept of the above figure is a combination of a thorough and comprehensive

understanding of the relationship between various quality components, in addition to the
understanding gained from the system theory. As stated previously, quality planning is a
part of the project planning, therefore, input is always received from there. Next, quality
planning gives required inputs to both quality assurance and quality control. After which,
the appropriate processing the outputs from QA and QC exchanged between them as
extra input source, which simply means QA gets its inputs from QC and quality
planning. The same is true for QC. Finally both QA and QC provide feedback to the
whole project planning, and from there new or modified quality plans feed the quality
planning accordingly.
Here in table (3-1) are some of the important inputs, processes used, and outputs of the
QMS as stated in the PMBOK guide (PMBOK guide, 2004, pp.182)
QMS System Data
Table (2-1)
Quality Planning Quality assurance Quality control
Inputs 1- Enterprise 1- Quality 1- Quality

environmental management management
factors. plan. plan.
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2- Organiza onal 2- Quality metrics. 2- Quality
process assets. 3- Quality control metrics.
3- Project scope measurements 3- Work
statement. performance
informa on
Processes 1- Cost-beneﬁt 1- Quality planning 1- Cause and

used analysis. tools and eﬀect
2- Benchmarking techniques. diagram.
3- Cost of quality 2- Quality audits. 2- Sta s cal
3- Process analysis sampling.
3- Inspec on.
Outputs 1- Quality 1- Requested 1- Quality
management changes. control
plan. 2- Recommended measurement
2- Quality metrics. correc ve s.
3- Quality ac ons . 2- Requested
checklists. 3- Project changes.
management 3- Validated
plan updates. deliverables.
It is known that, when a contract is signed to build a power plant, the owner, contractor,
and consultant will agree on the quality standards and protocols. While the contractor is
responsible for delivering the final project according to the contractual agreement,
therefore, he will definitely do all the required actions to fulfil that. This includes
erection work, quality control, and so forth. Whereas the owner and consultant are
required to assure that the project has been done as the contract specified. Based on these
points, considering the different roles of each party, the following general QMS has been
designed accordingly.
2.4 Setting QMS Objectives and Requirements
The general QMS framework which was discussed previously has been shown in a
presentation to Garri4 project staffs, accompanied with definitions on the meaning of
QMS, differences between QA and QC, and the benefits that the project will gain from
applying it.
After this presentation, two meetings were held with the project staffs. They mainly
consisted of brainstorming to set QMS objectives and requirements. Many jobs were
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assigned to staff members, in order to classify all the project jobs into traceable system
loops. Finally, the following items came out:
1- QMS objectives
2- QMS requirements
3- Traceable activity loops and the final QMS frame.
The objectives and requirements can be discussed later, here we can talk about traceable
activity loops in the final and approved QMS frame work.
2.4.1 Traceability Activity Loops:
The erection activities in the Garri4 project, for the purpose of applying the QMS, have
been divided into 6 loops. Each loop with its documentation system:
1- Inspection work loop and its documentation system

2- Erection Defects loop and its documentation system
3- Design Modifications (Change Requests) loop and its documentation system
4- Inspection Devices Folder
5- Equipments and Materials loop and their documentation system
6- Daily Work follow-up (site notes)
Inspection loop and its documentation system
Figure (2-4)
The following text explains this loop:
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1- Inspection procedures received from CMEC must be checked for approval, the
approved procedures should be kept in (Approved Procedures) file, if not
approved, then, it should be returned back to CMEC with clarifications.
2- After CMEC runs an inspection, which should be witnessed by NEC/LI, the
inspection form/test, result/film should be sent to NEC/LI, after the proper check
according to the requirements. If it is consistent, then the job is over and should be
kept in (Received Inspection) file. The same file can be divided into finished
inspection work /pending inspection work.
3- If the inspection result is not consistent with requirements, a NCR (Non-Conform-
Report) should be sent to CMEC cited by the inspection form/results. A copy
should be kept in (NCR) file.
4- The corrective actions which to be done by CMEC accordingly, which should be
kept on (Corrective Actions Report) file, and then the loop continues again to
the procedures and the re-inspection.
2.4.2 The Final QMS frame work
Finally, the previous general frame work is extended and detailed by the objectives/requirements/
and activity loops outcomes. Figure (3-6) shows it. It is not clear (has been drawn to be seen in
an A0 paper) but it will also be shown in separate figures to be clearer:
Final QMS Frame Work for Garri4 Project
Figure (2-5)
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Below is the Summary of QMS Process flowchart
• CMEC should send all the QC results, all the requested corrective actions reports,
all change requests, all defect repairs reports, procedures, and so on, before
reasonable time to NEC/LI.
• NEC/LI should check all these documents received from CMEC and assign each
document to the relevant loop, they should check the conformity to standards and
contractual requirements, they should inspect the QC results, and they should
carry out the appropriate auditing process, this audit and evaluation process is an
expert judgement, which includes certified knowledge and experience.
• NEC/LI should report to CMEC any defect detected in project site and state the
corrective actions required, also NEC/LI should consider the commercial issues
followed by inconsistencies in contractual requirements by the contractor, or as an
impact of design modifications.
• CMEC should send back a report about any requested action from NEC/LI, also
CMEC is requested to send their inspection schedule and procedures in advance
to allow enough time for NEC/LI preparing for it.
• Every step/loop should be documented.
• QC/QA results should be analyzed periodically.
• NEC staff should be given scheduled certified QA training opportunities, so as to
do the auditing/evaluation/supervision job efficiently.
2.5 Research Methodology
Implement of the matrix model to measure the effectiveness of the QMS in Garri4
project will be made. There are two matrices:
1- Matrix of principles: used to measure the effectiveness of achieving specified

QMS requirements stated by Garri4 project management team.
2- Matrix of goals: used to measure the effectiveness of achieving prescribed QMS
objectives and goals expected by Garri4 project management team.
Each matrix is comprised of four rows as follows
• First row: Quality characteristics which will be defined and determined by the
firm.
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• Second row: Percentage or weight (frequencies) should be assigned to each of the
above quality characteristics according to the questionnaire result, given the
symbol (W).
• Third row: Sequence of importance of these characteristics to the firm. They can
be given as a scale from 1 to 10 or to 6 according to the total number of quality
characteristics, and can be determined by the management team’s priorities in the
questionnaire, given the symbol (I).
• Fourth row: showing the Score, which equals the sum of W and I multiplied. The
score reflects the effectiveness rate of QMS in the company, given the symbol (S).
The following example table illustrates the matrix model for objectives as an example.
Only two characteristics are given for illustration purposes:-
Matrix Model Example
Table (2-2)
Quality Characteris cs 1- Mee ng Cont ractual 2- linking ac vi es others

requirements systema cal ly à
Weight(Yes answers
percentage) (W)
Importance (I)
Score = W × I
The outcome from the above matrices will be used to produce the following matrix
characteristics in order to measure the effectiveness of the QMS:
• L (limit): it is the limit of success and effectiveness, the company will make
assumptions about it, for example 60% can be the minimum limit of success to
meet the QMS objectives (we will add it to the questionnaire, and we will take the
higher frequency choice (the Mode), if they become varied, then the Mean can be
taken in consideration.
n
• FQS (Final Quality Score): which equals ∑ S , where n is the number of scores.
i =1
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n
• FQL (Final Quality Limit): which equals L ∑ I , where I is the importance, and
i =1
L is the limit. The FQL after applying the QMS will equal the FQS before
applying the QMS. Because the FQS before applying the system will be a good
indicator of the real situation prior to the QMS implementation. Therefore we
equate it to the FQL after QMS implementation to examine whether the QMS
implementation would change it or not.
The normal process is to compare FQS with FQL, if FQL ≥ FQS, then the project
has successfully met the QMS objectives and goals effectively, and if it is less,
then the opposite is true; it has failed to meet it.
The following shall be done:
1- Implementation of the matrix model before and after the QMS implementation
must be done. A comparative analysis should be made, the resulting FQS from
the first measure will be the FQL for the second measure, in order to check
whether things will improve after the QMS implementation or not.
2- The above needed data from the questionnaires will be collected.
2.5.2 Matrices Inputs
The quality requirements for the matrix of principles and the QMS objectives for the
matrix of goals have been determined, after the literature review and the meetings which
were held with the project staff, to be the following:
(1) Quality objectives:
1- Assure that the project as a whole meets contractual quality requirements.

2- Link the whole activities together systematically, so every one will know what to
do, when, and how
3- Provide powerful tools for documentation control
4- Provide the upper management of the project with adequate reports.
5- Involvement of every engineer in quality activities
6- Good communication with the contractor
7- Good cooperation between different client’s departments
8- Improve qualifications through learning and training
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9- An excellent case study for future projects
(2) Quality requirements:
1- Safety guidance implementation

2- Establishing proper documentation system
3- Determining quality objectives
4- Following the loop of each QMS process
5- Following ISO 9001:2000 guidance
6- Availability of activities and tests schedule in advance
7- Proper Computer database for all activities
8- Availability of all standards, scope, contract documents, and all quality related
documents
9- Clear job definition
10- Good understanding of the QMS principles
(3) Weight and Ranking procedures:-
The above quality objectives and requirements will be included in the questionnaire.
From it the weight and rank of these items can be determined. The weight will be the
percentage of (Yes) answers in relation to the total number of (Yes/No) answers. Each
individual will be asked to rank these items according to their perceived importance to
him/her. Following this, the rank of each item can be statistically determined, by taking
the higher frequencies of the given ranks. In addition to that, for sensitivity and validity
considerations, other trial calculations will be made for our matrix result using different
ranking according to the mean for each of the QMS objectives and requirements.
2.6 Summary Before & After QMS -Briefly

From the calculations using formula shown in section 2.5, the obtained results for QMS
implementation in Garri4 project are as the following:
1- QMS objectives have been met during the experiment period, FQL > FQS in both
cases, either by using the Mode or the Mean.
2- QMS requirements have not been met, as FQL<FQS by 543 (2157-2700 = - 543)
when we calculate by the Mode, and have been met when we used the Mean in
our calculations, however, FQL>FQS slightly (2560-2547 = 13). Therefore, for
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sensitivity considerations, we can assume from these results that the QMS
requirements during the experiment period were not satisfied and have not been
met accordingly.
2.7 ISO Standards
ISO 9001:2008 Quality Management Systems - Requirements contains the general
requirements for a quality management system. The standard is applicable to all
companies including manufacturing and service providers. The most recent revision was
in 2008. The ISO 9001 standard is on a regular schedule of review and improvement.
ISO 13485: Medical Devices - Quality Management Systems - Requirements for

Regulatory Purposes is designed for the medical device industry. A number of changes
from the ISO 9001 foundation have been made. These changes include the following:
The emphasis on continual improvement has changed to maintaining your product and
system. The emphasis on customer has taken a slightly different form. More
documentation is required by this standard than in the ISO 9001 standard.
ISO/TS 16949:2002 Quality management systems -- Particular requirements for the

application of ISO 9001:2008 for automotive production and relevant service part
organizations management systems is designed for the auto industry and suppliers to the
auto industry.
There are many other standards that may be of interest or use to you. A few of these are
listed below including some industry specific standards. All ISO standards are available
through the International Organization for Standardization. They may also be available
through other organizations or through the approving body in your country.
• AG9000:2000 International Quality Standard with Focus on Implementation

Guidelines for Grain Farmers is in development for farms, seed producers and
related businesses. This standard is an ISO 9001 based quality system. It will be
released by the American Society of Agricultural Engineers(ASAE).
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• AS9100 Quality Systems - Aerospace - Model for Quality Assurance in Design,
Development, Production, Installation and Servicing is available from the Society
of Automotive Engineers.
• ISO 10012:2003 Measurement management systems -- Requirements for

measurement processes and measuring equipment
• ISO 10013:2001 Guidelines for quality management system

documentation (available in English only)
• ISO 10015 Quality management -- Guidelines for training
• ISO 10993 Biological Evaluation of Medical Devices
• ISO 11607: Packaging for terminally sterilized medical devices
• ISO 14001:2004 Environmental management systems -- Requirements with

guidance for use. Revised in 2004 to make this standard easier to implement.
• ISO 14004:2004 Environmental management systems -- General guidelines on

principles, systems and support techniques
• ISO/TR 14969 Quality Management Systems - Medical Devices - Guidance on

the Application of ISO 13485
• ANSI/AAMI/ISO 14971:2000 and 14971/A1:2003 Medical Devices -Application

of Risk Management to Medical Devices
• ISO 15161:2001 Guidelines on the application of ISO 9001:2000 for the food and
drink industry
• ISO 15189:2003 Medical laboratories - Particular requirements for quality and

competence.
• ISO 19011 Guidelines for quality and/or environmental management systems

auditing
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• ISO 22000:2005 Food Safety Management Systems- Requirements for any
Organization in the Food Chain. This standard applies to all organizations in the
food supply chain: including but not limited to: feed producers, food producers,
food manufacturers, transport and storage, subcontractors, retailers, equipment
and packaging manufacturers, additivies, ingredients, and sanitation chemicals.
• ISO/TS 22004:2005 Food Safety Management Systems - Guidance on the

Application of ISO 22000:2005.
• ISO/TS 27001:2005 Information Technology - Security Techniques-Information

Security Management System - Requirements. A newer standard getting a lot of
emphasis rgiht now as so many of us rely on the internet.
• ISO/PAS 28000:2005 Specification for security management systems for the

supply chain .
• TL 9000 Requirements Handbook (Release 3.0) Quality Management System

(QMS) Requirements Handbook establishes and details hardware, software and
services quality system requirements for the telecommunications industry
• OHSAS 18000 is an international occupational health and safety management

system specification. It comprises two parts, 18001 and 18002 and embraces
BS8800 and a number of other publications.
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CHAPTER – 3
METHODOLOGY
3.1 Approach Adopted
3.1.1 Gap Analysis / Need Analysis Method
A need Assessment is a systematic exploration of the way things are and the way they
should be. These "things" are usually associated with organizational and/or individual
performance.
Four Steps to Conduct Gap Analysis / Need Assessment

Step: 1 Carry Out "GAP" Analysis
The first step is to check the actual performance of our organizations and our people
against existing standards, or to set new standards. There are two parts to this:
• Current situation: We must determine the current state of skills, knowledge, and
abilities of our current and/or future employees. This analysis also should examine
our organizational goals, climate, and internal and external constraints.
• Desired or necessary situation: We must identify the desired or necessary

conditions for organizational and personal success. This analysis focuses on the
necessary job tasks/standards, as well as the skills, knowledge, and abilities
needed to accomplish these successfully. It is important that we identify the
critical tasks necessary, and not just observe our current practices. We also must
distinguish our actual needs from our perceived needs, our wants.
The difference the "gap" between the current and the necessary will identify our needs,
purposes, and objectives.
Step: 2 Identify Priorities and Importance

The first step should have produced a large list of needs for implementation and/or other
interventions. Now we must examine these in view of their importance to our
organizational goals, realities, and constraints. We must determine if the identified needs
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are real, if they are worth addressing, and specify their importance and urgency in view
of our organizational needs and requirements.
• Cost-effectiveness: How does the cost of the problem compare to the cost of
implementing a solution? In other words, we perform a cost-benefit analysis.
• Legal mandates: Are there laws requiring a solution? (For example, safety or
regulatory compliance.)
• Executive pressure: Does top management expect a solution?
• Population: Are many people or key people involved?
• Customers: What influence is generated by customer specifications and

expectations?
If some of our needs are of relatively low importance, we would do better to devote our
energies to addressing other problems with greater impact and greater value.
Step: 3 Identify Cases of Performance Problems and / or Opportunity

Now that we have prioritized and focused on critical organizational and personal needs,
we will next identify specific problem areas and opportunities in our organization. We
must know what our performance requirements are, if appropriate solutions are to be
applied. We should ask two questions for every identified need
• Are our people doing their jobs effectively?
• Do they know how to do their jobs?
This will require detailed investigation and analysis of our people, their jobs, and our
organizations -- both for the current situation and in preparation for the future.
Step: 4 Identify Possible Solution and Growth Opportunity

If people are doing their jobs effectively, perhaps we should leave well enough alone.
("If it ain't broke, don't fix it.") However, some training and/or other interventions might
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be called for if sufficient importance is attached to moving our people and their
performance into new directions.
But if our people ARE NOT doing their jobs effectively:
• Training may be the solution, if there is a knowledge problem.
• Organization development activities may provide solutions when the problem is

not based on a lack of knowledge and is primarily associated with systematic
change. These interventions might include strategic planning, organization
restructuring, performance management and/or effective team building.
3.2 Method of Investigating Organization and Personnel
Use multiple methods of Needs Assessment. To get a true picture, don't rely on one
method. It is important to get a complete picture from many sources and viewpoints.
Don't take some manager's word for what is needed.
There are several basic Needs Assessment techniques. Use a combination of some of
these, as appropriate:
• Direct observation
• Questionnaires
• Consultation with persons in key positions, and/or with specific knowledge
• Review of relevant literature
• Interviews
• Focus groups
• Tests
• Records & report studies
• Work samples
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An excellent comparison of the advantages and disadvantages of each of these methods
can be found in the Training and Development Journal. (7)
Remember that actual needs are not always the same as perceived needs, or "wants".
Look for what the organization and people really need they may not know what they
need, but may have strong opinions about what they want.
Use your collected data in proposing QMS solutions:
• Use your data to make your points. This avoids confronting management since
your conclusions will follow from your Needs Assessment activities.
• Everybody should share the data collected. It is important to provide feedback to

everyone who was solicited for information. This is necessary if everyone is to
"buy into" any proposed training or organization development plan.
Having identified the problems and performance deficiencies, we must lay out the
difference between the costs of any proposed solutions against the cost of not
implementing the solution. Here's an economic "gap analysis":
• What are the costs if no solution is applied?
• What are the costs of conducting programs to change the situation?
The difference determines if intervention activities will be cost-effective, and therefore if

it makes sense to design, develop, and implement the proposed solutions.
3.2.1 Interview Method for Gap / Need Analysis
Several types of interviews exist: topical oral history, life history, evaluation interview,
focus group interview, and cultural interviews.
Topical interviews: are concerned with the facts and sequence of an event. The
interviewer is interested in a reconstruction of the experience and what happened; for
instance, what happened at the InSEA Conference in Brisbane Australia. The researcher
actively directs questions in pursuit of precise facts.
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Life histories: deal with individual experiences or rites of passage. In oral histories, one
collects information about a dying lifestyle or art skills. These result in narratives and
stories that interpret the past.
Evaluation interviews: examine new programs or school developments and suggests

improvements. Since evaluation deals with incorrect behaviors as well as positive ones,
justifications [accounts] of behaviors result. The result may consist of myths and
unresolved tensions (Patton, 1990).
In focus group interviews: people meet to share their impressions and changes of
thinking or behavior regarding a product or an institution. Participants may be strangers
and make an effort to preserve their competency and may not admit faults.
The cultural interview focuses: on Òthe norms, values, understandings, and taken-for-
granted rules of behavior of a group or societyÓ (p. 28). This type of interview reports
on TYPICAL shared activities and their meanings. The style of interview is relaxed and
questions flow naturally with no fixed agenda. People are interviewed several times so
that emerging themes are pursued later. The interviewer, for example, may ask them to
DESCRIBE A TYPICAL DAY. The partner then relates what is important with
examples. The truth of the fact is not as important as Òhow well it illustrates the
[cultural] premises and normsÓ (p.29). For example, in a Christian culture, you may be
told about the significance of the value of behaving with concern for other people (p.
29). In the cultural interview, the interviewer is partner and co-constructs the interview
and report. The cultural report, besides being the expertÕs story, is credible because it
consists of the words of members of the culture. We assume that people are basically
honest and that they share similar views. The researcher can mix types of interviews and
approaches.
3.2.2 Qualitative Interview
Qualitative interview method had been used to analyze current situation at Business
partner works.
Qualitative interview is different from everyday conversation in the following ways.

First it is a research tool and a good interviewer must prepare structured questions in
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advance, and later analyze and report results. The interviewer guides the questions and
focuses the study. Good interview skills require practice and reflection. Finally, beyond
the acquisition of interview skills, interviewing is a philosophy of learning. The
interviewer becomes a student and then tries to get people to describe their experiences
in their own terms. The results are imposed obligations on both sides. The qualitative
researcher’s philosophy determines what is important, what is ethical, and the
completeness and accuracy of the results (Rubin & Rubin, 1995, p.2).
3.2.2.1 Advantage
• Provides depth and detail : looks deeper than analysing ranks and counts by
recording attitudes, feelings and behaviours
• Creates openness: encouraging people to expand on their responses can open up

new topic areas not initially considered
• Simulates people's individual experiences: a detailed picture can be built up

about why people act in certain ways and their feelings about these actions
• A emp t s to avoi d pr e- judgeme nt s: if used alongside quan ta ve dat a col l ec on, i t can
explain why a par cul ar respons e wa s gi ven
3.2.2.2 Disadvantage
• Usually fewer people studied: collection of qualitative data is generally more

time consuming that quantitative data collection and therefore unless time, staff
and budget allows it is generally necessary to include a smaller sample size.
• Less easy to generalize: because fewer people are generally studied it is not
possible to generalize results to that of the population. Usually exact numbers are
reported rather than percentages.
• Difficult to make systematic comparisons: for example, if people give widely

differing responses that are highly subjective.
• Dependent on skills of the researcher: particularly in the case of conducting

interviews, focus groups and observation.
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3.2.3 Guidelines for Structured Interview
Use standard explanations of the study
• Never deviate from the study introduction, sequence of questions, or question

wording
• Never let another person interrupts the interview; do not let another person answer
for the respondent or offer his or her opinions on the question.
• Never suggest an answer or disagree with an answer. Do not give the respondent any
idea of your personal views on the topic of the question or survey.
• Never interpret the meaning of a question; just repeat the question.
• Never improvise, such as by adding answer categories, or make wording changes.
3.3 Qualitative Interview Questionnaire
The Questionnaire was prepared based on referring the Quality Management System
(ISO 9001:2008), Departmental Procedures, CDQ directory of Bosch. This structured
Questionnaire was prepared to evaluate existing QMS available at Business Partner
Works.
Sample Questionnaire
Figure (3-1)
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CHAPTER – 4
RESULT AND DISCUSSION
4.1 Findings through Gap Analysis
4.1.1 Top Management
Top Management - Questionnaire & Findings (Figure 4-1)
Sl.No. Description Observation / Findings
1 Business Plan available? Not available
Resource Management:
a) Records of education, skills,

experience.
2 Not available
b) Work space, process equipment
(Hardware, software)
c) Employee welfare ESI, EPF, etc.,
Quality Policy & Quality objective Not available

3
defined?
4 Quality Manual available Not available
Employee competency matrix Not available

5
monitored?
Development training program planned Not in Practice

6
for employees?
Lesson learnt & continuous Not recording and monitoring

7
improvement carried out?
Management Review & other project Not happening

8
reviews?
9 Receiving Customer feedback? Not Receiving
10 Review of Customer complaint done? Not happening
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How project schedule are Not communicating / one man show
11
communicated with all levels?
General Discussion: For effective QMS implementation top management must have
total commitment, in communicating the importance of meeting customer requirements
as well as statutory and regulatory requirements, establishing the Quality Policy &
Quality Objectives, conducting management review meetings and ensuring availability
of resources.
4.1.2 Sales and Marketing
Sales and Marketing – Questionnaire & Findings (Table 4-2)
- Over Phone, requirements/ drawings

through courier
1 How enquiry is received
- No marketing activity carried out, only
through personal touch getting enquiry
- Targeted Response Time: 2days
2 How Quotation is prepared? - No register available for enquiry received,

Quotation sent, Order received
- In-house machine availability and based

Capability to execute, how it is assessed?
on geometrical accuracy
- Cost worked out in a book

Cost and delivery, how it is assessed?
- Delivery not worked
- Stop production until receive new

drawing
3 How Change request are handled?
- No register maintained
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- Cost worked out in a book
How it is assessed? (in terms of Quality,
Cost, Delivery) - Delivery not worked
- Tear down old drawings/requirements and

How it is communicated?
update with new drawings
How order acceptance is given to - Not giving order acceptance

4
Customer?
- Not monitoring the target fixed

5 Response time from enquiry to quote
- No CAPA for delayed ones
6 How follow-up done for project - Not doing Quotation status follow-up.
- Project time schedule not available
7 How status follow-up done for the project - New Project not shared with department
officially
8 How work order numbers are given? - No register available
General Discussion: The general requirement of QMS implementation is to monitor,

measure, analyze and take necessary corrective and preventive action to meet the
customer requirements. Meeting customer requirements can be achieved by setting
quality policy and objectives. This will be reviewed monthly ones and take necessary
action if it crosses the quality objectives set by the organization.
4.1.3 Planning
Planning – Questionnaire & Findings (Table 4-3)
- This is done by the same person who

1 How requirements are received?
does quotation and acceptance work.
Page 39 of 57
Risk assessment is carried out? (In - Not available
2
terms of Quality, Cost & Delivery)
- Scheduling done based on long,

Medium & Short lead time
3 How Scheduling done? manufacturing
- No Records available
How process planning done and - Separate note book available where
4
executed? process is defined for each component
- Process inspection are carried out but

not documented
Inspection plan available for each - Incoming inspection done but not
5
component? documented
- Final inspection done for all
component and record maintained
6 How raw materials are planned? - No register for material planning
How inputs for production or - Materials and drawings are given to

7
manufacturing given? operator for that day
How planned processes tracked, and - Process plan register monitored

8
confirm all process completed?
9 How routing done for WIP - Process plan register monitored
General Discussion: To meet customer requirements organization must plan and

develop the process require for product realization. The plan consists of manufacturing
and inspecting during process and inspecting at final to ensure customer specification or
requirements met.
4.1.4 Manufacturing
Manufacturing – Questionnaire & Findings (Table 4-4)
Page 40 of 57
- Planning done 2 days back

1 How capacity planning done?
- No record available
- Materials and drawings are given to

2 How requirements are received?
operator for that day
- Priority wise planned

How capacity availability is worked
3
out? - No record available
How identification and traceability at - Not Following

4 various stages of manufacturing
process followed?
Periodic maintenance of machine is - Not Following

5
carried out?
6 Checklist available? TPM? - Not Following
7 Spare parts for machine planned? - Not Following
8 History card available for machines? - Not Following
Have register for Breakdown - Not Following

9
maintenance?
Personnel Protective Equipments - Not Following

10
(PPE) is Planned?
General Work Instruction for Machines - Not Following

11
available?
- Not Following for WIP

Identification and traceability of WIP
12
and FG components - Done for FG components
General Discussion: The Manufacturing activity involves execution of process

planned for each component. Normally manufacturing activity for our business
requirement (section 1.3 6th paragraph) is done on general purpose machines like, lathe,
Page 41 of 57
drilling machine, milling machine, jig boring machine, horizontal and vertical boring
machine, grinding machine, etc.,
So planning these machines to be loaded for each day is very important to meet
delivery schedule and quality of the component or jigs or fixtures supplied by business
partner. Especially maintaining the machine at good condition is very important. To
maintain machine properly organization must have periodical maintenance of machine,
daily checklist to keep the machine clean, breakdown register and wear out parts planned
much before.
4.1.5 Quality
Quality – Questionnaire & Findings (Table 4-5)
- Old drawings are torn

Drawing availability with version
1
control? How it is monitored? - No register available
Quality plan available for critical - Not making quality plan for critical
2
assemblies / critical parts? items
- Incoming inspection done

Incoming inspection is carried out and
3
recorded? - Deviation register not available
- All three inspections are carried out

In-process inspection, incoming
for each component
4 inspection and final inspection carried
out and recorded?
- Rejection register not available
Customer complaints register - Not available

5
available?
Master list of measuring instruments - Not available

6
available?
Page 42 of 57
Periodical Inspection planned for - Not available
7
instruments and gauges
8 Supplier Quality level monitored? - Not monitoring
9 House Keeping (5S) being done? - Not following
Problem solving tool 8D, CAPA - Not following

10
followed?
11 Periodical assessment of supplier done - Not doing
General Discussion: Generally quality department checks the quality of product at each
process, incoming and final inspection to assure the quality requirements of product is
met to keep the customer satisfied.
To meet the quality requirements the instruments, gauges used to check the component
or product are planned for periodical maintenance, repair or buy new.
It also keeps record of all quality related complaints at in-house manufacturing and
outsourced components. The quality department takes initiative to solve the quality
complaints by using quality tools like CAPA, 8D, 7 QC tools, etc.,
4.1.6 Purchase
Purchase – Questionnaire & Findings (Table 4-6)
Master list of approved supplier - No available

1
available?
- Accuracy wise, Machine availability

2 On what basis supplier selection done?
- No document available
- Stop manufacturing through phone or

How alteration notes are communicated oral communication.
3
to the supplier?
- Production or further action planned
Page 43 of 57
only after receiving new requirements or
specification
How enquiry and PO placed on - Not following

4
supplier?
- High light drawing or oral

How specifications are conveyed to communication
5
supplier?
- Not following systematic
6 How Cost & Delivery worked out - Enquiry not send to different supplier
How follow-up with supplier being - Orally

7
done?
- Local Supply – Bubble Sheet

8 On what basis packing method defined?
- Outside – Wooden box
- Based on requirements/Part list

9 How standard parts are planned?
- No register available
General Discussion: Purchasing activity involves both outsourcing of complete

manufactured component or product from supplier and purchasing of standard part
available in the market.
Supplier selection is very vital for manufacturing and delivering the quality component
with exact delivery schedule. The organization must have approved supplier master list
and categorizing each supplier according to specialization of job type.
Page 44 of 57
CHAPTER – 5
CONCLUSION AND RECOMMENDATION
5.1 Overview of Study
According to section 1.1, section 1.2.1 & section 1.3, a study has been conducted to
implement Quality Management Systems at Business partner works (M/s. Precision
Techniques). The sections mentioned above had been taken as input for further process
of this study to assess and analyze the existing QMS available at Business partner works
through Qualitative interview method.
The observed findings were listed out in the previous section according to the specific
questionnaire adopted or structured for this business partner. Most of the questions were
answered “Not following”, “Not available”, “No”. This really made the Business partner
to think about the benefits that can be reaped through implementing QMS at his work
place.
The results were discussed with Mr. Venugopal proprietor of M/s. Precision Techniques
and arrived to a conclusion of taking action for all the open points to bridge the gap.
According to section 3.1.1, step 2 of gap analysis or need analysis, the significant and
essential points had been taken for first phase of QMS implementation. Once first phase
get stabilized the second phase of implementation can be planned.
In this chapter, going to see which points are taken care on the phase of QMS
implementation and second phase of implementation.
5.1.1 First Phase of QMS implementation
First Phase of QMS implementation (Table 5-1)
Page 45 of 57
# Description Observation Action Respon. Status
Quality policy and Not available Define quality Venugop Done

quality objectives policy and al
1
available? objective of the
organization
Employee Not available Competency matrix John Done

2 competency matrix format to be Joseph
available? formulated
3 Receiving customer Not following Customer feedback John Progre

feedback? form to be prepared Joseph s
4 How project Order register A excel format to John Done

enquiry, quotation, and change be prepared for Joseph
change request and request register monitoring
response time are not available response time and
monitored? change request
5 How follow-up Time schedule To start time John Done /

done for project not planned and schedule has to be Joseph Progre
recorded planned and ss
recorded for critical
project. Format to
be planned
6 How project Not To plan for big Venugop Done

schedule are communicating / white board to al
communicated with one man show communicate
all level in project scheduled
organization? for each month
Page 46 of 57
7 Periodical No Plan periodical Venugop CW45
maintenance carried maintenance for all al
out for all machines
machines?
8 Have Breakdown Not available To format a register John CW43

register for to monitor Joseph
machines?
9 Work instruction Not available 1. Work instruction John Done

available for all the format to be given. Joseph
Progre
machines?
2. To display the Venugop ss
work instruction al
10 Identification and No identification Card to be planned Venugop CW45

traceability of card available for rejection and al
component for rejection and rework.
available? rework
Rejection – Red
Rework - Yellow
11 Rejection register Not available To make rejection Venugop Done

available for in- register for inhouse al
house and and outsource
outsource? component
12 Customer Not available To make customer Venugop Done

complaints register complaint register al
available?
Page 47 of 57
13 Master list of Not available To make a master Venugop Done
measuring list of instrument al
instruments and and PI planned
periodical
maintenance
available?
14 Master list of Not available To make master list Venugop Done

approved supplier of approved al
available suppliers
5.1.2 Second Phase of QMS implementation
All other points which are left in the first phase have to be planned at second phase of
QMS implementation. This work will be carried out sincerely because this study was
conducted not only for academic fulfillment but also for my organization benefits.
5.2 Expected Benefits through study
Business Partner:
1. Common understanding and focus by all, regarding company objectives. Through

PDCA approach (Appendices-A)
2. Enhancement of knowledge/skill of personal through competency matrix(Appendice –B)
3. Customer focus through customer satisfaction feed back
4. Faster response time for enquiry. Approximately from 4 days to 2 days. (Appendices – C)
5. Faster delivery time for orders. Approximately 30% of improvement

6. Consistent quality of part produced. Through proper Preventive maintenance of machine
and PI of instruments (Appendices – D)
7. Minimize accident through clear work instruction for machines
8. Reduction in incoming rejection. Reduce approximately 25% (Appendices – E)
9. Faster response to customer complaints and prevent recurrence of complaints
Page 48 of 57
Organization:
1. Reduction in rejection percentage. From 4.2% to 2%

2. Consistent Quality of Parts
3. Elimination of repeated complaints
4. Commitment of Business partner
5. Partner shall become more competitive.
Page 49 of 57
APPENDICES – A
Defined Quality Policy and Quality Objectives for M/s. Precision Techniques
QUALITY POLICY
PRECISION TECHNIQUES IS COMMITTED TO MANUFACTURE & SUPPLY OF JIGS

& FIXTURE, PRECISSION MACHINED COMPONENTS TO THE SATISFACTIOM OF
THE CUSTOMER.
THIS SHALL BE DONE BY.
01. COMPLYING WITH ALL STATUTORY AND REGULATORY REQUIREMENTS

.
02. THROUGH SYSTEMATIC MONITORING, MAINTAINING AND CONTINUAL

IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM.
03. PROVIDING A FRAMEWORK FOR ESTABLISHING REVIEWING AND

IMPROVING QUALITY OBJECTIVES.
04 INVOLVING ALL ITS EMPLOYEES.
QUALITY OBJECTIVES.
PRECISSION TECHNIQUES HAS ESTABLISHED THE FOLLOWING QUALITY

OBJECTIVRS IN LINE WITH THE QUALITY POLICY.
01. REDUCTION OF CUSTOMER COMPLAINTS.
02 REDUCTION OF RE WORK & REJECTION.
03 IMPROVEMENT OF ON TIME DELIVERY
04 IMPROVEMENT OF CUSTOMER SATISFACTION.
05 IMPROVEMENT OF PRODUCTION PERFORMANCE.
Page 50 of 57
APPENDICES – B
Competency Matrix Format
Page 51 of 57
APPENDICES – C
Order Tracking Register
Page 52 of 57
APPENDICES – D
Periodical Inspection of Instrument – Master List format
Page 53 of 57
APPENDICES – E
Rejection Register for Incoming & In-House
Page 54 of 57
APPENDICES – F
Supplier Selection Process followed at Business Division
Page 55 of 57
APPENDICES – F
Page 56 of 57
REFERENCES
1) Bosch Guidelines & standards, Central Directives Quality (CDQ’s),

CDQ_Management of Quality Management System and Process audits internally and
at suppliers.
2) Quality Management Systems – Requirements (Third Version), Bureau of Indian
Standards.
3) Supplier assessment, internal system audit format.
4) Departmental Procedures and guidelines
5) http://www.globalqualityvillage.com/qmprinciples.php
6) http://www.questanalytical.com/ISO%20Standards/ISO%2016949/ISOts16949.htm
7) http://alumnus.caltech.edu/~rouda/T2_NA.html
Page 57 of 57
Dissertation_Quality Improvement through QMS Implementation
Quality Improvement through QMS

implementation at Business Partner Works
1 Internal | QMM-AT | 20/10/2010 | © Bosch Limited 2010. All rights reserved, also regarding any disposal, exploitation, reproduction, editing,
distribution, as well as in the event of applications for industrial property rights.
Importance of Study
è ATMO (Assembly System & Special Machinery), a Business Unit of Bosch, is a globally
acting Bosch-integrated special machine builder.
è The range of services reaches from manual lines to fully automated systems.
è The manual and automated lines are built through various elements such as mechanical,
electrical, pneumatics, hydraulic and integrating the elements through software. The
qualities of these elements directly or indirectly affect Quality, Cost & Delivery (QCD).
è ATMO customers look for cost effective solution without compromising quality & delivery
of the service.
è To accommodate the customer requirement, ATMO team working towards developing
the supplier who can meet both quality & delivery time at low cost.
è I strongly believe to meet QCD; an industry should possess an effective Quality
Management System (QMS).
è So, the selected topic for the project will be vital for business growth for both Bosch and
Business partner.
è The Business partner considered for implementing QMS has been finalized by consulting
with Purchase department and analyzing the Quality statistics.
è Supplier Selected : M/s. Precision Techniques,
Assembly Machine: Example
Reason for Selecting Precision Techniques

è Manufacturer : Precision components, Jig, Fixtures & sub assemblies
è Positive Point: Technically sound, good attitude, good workmanship.
è Number of Employees: 7 Persons working for the company
è Infrastructure:
l Manufacturing Department : General purpose machines like, Jig Boring,
Milling machine, drilling machine.
l Quality department: Skilled person with essential equipments
l Planning Department: Process planning done for all the components.
è Negative Points: Repeated complaints, Not tracking/registering
customer complaints, Not tracking rejection of in-house and
outsourced rejection
è Rejection percentage: 4.2%
Reason for Selecting Precision Techniques

One of the Quality Policy of BOSCH:
è “Our suppliers contribute substantially to the quality of our products

and services. Therefore our suppliers must live up to the same high
quality standards we have adopted”.
è This study helped/helping our business partner to understand and

implement QMS at work place
Scope of the Study

è Assess existing level of QMS at Business partner works
è Identify Gap
è Fix actions to bridge Gap
è Implementation of actions
è Check for the effectiveness of action
è Final assessment of QMS
Methodology Adopted: Gap Analysis Method

è First Step: Carry out GAP analysis
l Check actual performance of the organization against existing
standard
l The difference between the existing and desired will identify our
need for improvement.
è Second Step: Identify Priority and Importance

l The first step should have produced a large list of needs.
l Now we must examine these in view of their importance
l The importance and urgency in view of our organizational needs
and requirements.
Methodology Adopted: Gap Analysis Method

è Third Step: Identify the cases of Performance Problem
l Now that we have prioritized and focused on critical organizational
needs
l We must know what our performance requirements are;
l Are our people doing their jobs effectively?
l Do they know how to do their jobs?
è Fourth Step: Identify Possible Solution / Growth opportunity

l If people are not doing the job effectively, training may be the
solution
l In some cases, organization development may provide solution
Qualitative Interview Method

è Gap Analysis can be done through multiple methods.
è Multiple Methods are;
l Direct observation
l Questionnaires
l Interviews
l Focus groups
l Test
l Records and report studies
l Work Samples
Qualitative Interview Technique

è Qualitative interview method had been used to analyze current
situation at Business partner works.
è A good interviewer must prepare structured questions in advance,
and later analyze and report results
Advantage:
è Information: Provides depth and detail information
è Create openness: Can open up new topic which was not considered
during preparation of questions

è Attitude: Pave a path to understand the behavior of the individual or
group
Guidelines for Structured Interview

è Never deviate from the study introduction, sequence of questions, or
question wording
è Never let another person interrupts the interview; do not let another
person answer for the respondent or offer his or her opinions on the
question.
è Never suggest an answer or disagree with an answer. Do not give
the respondent any idea of your personal views on the topic of the
question or survey.
è Never interpret the meaning of a question; just repeat the question.
è Never improvise, such as by adding answer categories, or make
wording changes
Structured Questionnaire
è The structured Questionnaire prepared to analyze current situation of business

partner.
è The Questionnaire covers, Department, Description, Notes, Responsible person
from organization, etc.,
First Phase: Action for Findings

Quality policy and quality Not available Define quality policy and Venugopal Done
1 objectives available? objective of the
organization
Employee competency Not available Competency matrix format John Joseph Done
2 matrix available? to be formulated
3 Receiving customer Not following Customer feedback form to John Joseph Progres
feedback? be prepared
4 How project enquiry, Order register and A excel format to be John Joseph Done
quotation, change request change request register prepared for monitoring
and response time are not available response time and change
monitored? request
5 How follow-up done for Time schedule not To start time schedule has John Joseph Done /
project planned and recorded to be planned and recorded Progress
for critical project. Format
to be planned

6 How project schedule are Not communicating / To plan for big white Venugopal Done
communicated with all one man show board to communicate
level in organization? project scheduled for each
month
7 Periodical maintenance No Plan periodical Venugopal CW45
carried out for all maintenance for all
machines? machines
8 Have Breakdown register Not available To format a register to John Joseph CW43
for machines? monitor
9 Work instruction available Not available 1. Work instruction format John Joseph Done
for all the machines? to be given. Venugopal Progress
2. To display the work
instruction
10 Identification and No identification card Card to be planned for Venugopal CW45

traceability of component available for rejection rejection and rework.
available? and rework Rejection – Red
Rework - Yellow

11 Rejection register Not available To make rejection Venugopal Done
available for in-house and register for inhouse and
outsource? outsource component
12 Customer complaints Not available To make customer Venugopal Done
register available? complaint register
13 Master list of measuring Not available To make a master list of Venugopal Done
instruments and periodical instrument and PI planned
maintenance available?
14 Master list of approved Not available To make master list of Venugopal Done
supplier available approved suppliers
Second Phase of action

è Quality Manual
è Training program for Quality Inspection person at BOSCH
è Employees welfare scheme like, ESI, EPF
è Management Review Meetings
è Capacity Planning
è History card for machines
è Personnel Protective Equipments
è Monitoring Supplier Quality Level
Benefits through Study: Business Partner

è Common understanding and focus by all, regarding company objectives. Through PDCA approach
(Appendices-A “Final Report”)
è Enhancement of knowledge/skill of personal through competency matrix (Appendices – B ”Final Report”)
è Customer focus through customer satisfaction feed back
è Faster response time for enquiry. Approximately from 4 days to 2 days. (Appendices – C “Final Report”)
è Faster delivery time for orders. Approximately 30% of improvement
è Consistent quality of part produced. Through proper Preventive maintenance of machine and PI of instruments
(Appendices – D” Final Report)
è Minimize accident through clear work instruction for machines
è Reduction in incoming rejection. Reduce approximately 25% (Appendices – E “Final Report”)
è Faster response to customer complaints and prevent recurrence of complaints
Benefits through Study: Organization (BOSCH)

è Reduction in rejection percentage. From 4.2% to 2%
è Consistent Quality of Parts
è Elimination of repeated complaints
è Commitment of Business partner
è Partner shall become more competitive.

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Quality Improvement through QMS

implementation at Business Partners Works

BITS ZG629T: Dissertation

Dissertation work carried out at

Bosch Limited, Adugodi, Bangalore – 560 030

BIRLA INSTITUTE OF TECHNOLOGY & SCIENCE

2.2 Design and Implementation QMS at Power Plant

The study consists of four sections:

Section 4: Analysis and Conclusions

2.3 The PMBOK Guide

PMBOK knowledge areas

As we discussed, quality as a system has inputs, processes and outputs, or outcomes,

The concept of the above figure is a combination of a thorough and comprehensive

QMS System Data

Quality Planning Quality assurance Quality control

Inputs 1- Enterprise 1- Quality 1- Quality

Processes 1- Cost-beneﬁt 1- Quality planning 1- Cause and

2.4 Setting QMS Objectives and Requirements

2.4.1 Traceability Activity Loops:

1- Inspection work loop and its documentation system

Inspection loop and its documentation system

The following text explains this loop:

Final QMS Frame Work for Garri4 Project

1- Matrix of principles: used to measure the effectiveness of achieving specified

Matrix Model Example

Quality Characteris cs 1- Mee ng Cont ractual 2- linking ac vi es others

The following shall be done:

(1) Quality objectives:

1- Assure that the project as a whole meets contractual quality requirements.

1- Safety guidance implementation

2.6 Summary Before & After QMS -Briefly

ISO 13485: Medical Devices - Quality Management Systems - Requirements for

ISO/TS 16949:2002 Quality management systems -- Particular requirements for the

• AG9000:2000 International Quality Standard with Focus on Implementation

• ISO 10012:2003 Measurement management systems -- Requirements for

• ISO 10013:2001 Guidelines for quality management system

• ISO 10015 Quality management -- Guidelines for training

• ISO 10993 Biological Evaluation of Medical Devices

• ISO 11607: Packaging for terminally sterilized medical devices

• ISO 14001:2004 Environmental management systems -- Requirements with

• ISO 14004:2004 Environmental management systems -- General guidelines on

• ISO/TR 14969 Quality Management Systems - Medical Devices - Guidance on

• ANSI/AAMI/ISO 14971:2000 and 14971/A1:2003 Medical Devices -Application

• ISO 15189:2003 Medical laboratories - Particular requirements for quality and

• ISO 19011 Guidelines for quality and/or environmental management systems

• ISO/TS 22004:2005 Food Safety Management Systems - Guidance on the

• ISO/TS 27001:2005 Information Technology - Security Techniques-Information

• ISO/PAS 28000:2005 Specification for security management systems for the

• TL 9000 Requirements Handbook (Release 3.0) Quality Management System

• OHSAS 18000 is an international occupational health and safety management

Four Steps to Conduct Gap Analysis / Need Assessment

• Desired or necessary situation: We must identify the desired or necessary

Step: 2 Identify Priorities and Importance

• Executive pressure: Does top management expect a solution?

• Population: Are many people or key people involved?

• Customers: What influence is generated by customer specifications and

Step: 3 Identify Cases of Performance Problems and / or Opportunity

• Are our people doing their jobs effectively?

• Do they know how to do their jobs?

Step: 4 Identify Possible Solution and Growth Opportunity

But if our people ARE NOT doing their jobs effectively:

• Training may be the solution, if there is a knowledge problem.

• Organization development activities may provide solutions when the problem is