ABC-Q-ML-0100 QMS Manual.doc

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Any comments and proposed changes on this manual and related procedures can be
directed to Process Owners, Quality Manager and/or Management Representative
(MR) for necessary action.
This Quality Management System (QMS) Manual is the property of the Company
and shall not be reproduced and distributed to third parties without the
authorization of the above.
As with all quality documents, this manual will be reviewed at least once a year to
confirm its suitability and effectiveness in supporting the QMS.
With the advent of computers, Process Owners shall make the latest version of
documents they produce available on a common drive. All users of such documents
are responsible for ensuring that they update themselves of the latest version.
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Table of Contents
1. Scope
1.1. General
1.2. Application
2. Normative Reference
2.1. Company Profile
2.2. Scope of Services
3. Terms, Definitions and Abbreviations
3.1. Title
3.2. System
3.3. Document Type
4. Quality Management System
4.1. General Requirements
4.2. Documentation requirements
4.2.1. General
4.2.2. Quality Manual
4.2.3. Control of Document
4.2.4. Control of Records
5. Management Responsibility
5.1. Management Commitment
5.2. Customer Focus
5.3. Quality Policy
5.4. Planning
5.4.1. Quality Objectives
5.4.2. Quality management system planning
5.5. Responsibility, authority and communication
5.5.1. Responsibility and Authority
5.5.2. Management Representative
5.5.3. Internal Communication
5.6. Management Review
5.6.1. General
5.6.2. Review Input
5.6.3. Review Output
6. Resource Management
6.1. Provision of Resources
6.2. Human Resources
6.2.1. General
6.2.2. Competency, Awareness and Training
6.3. Infrastructure
6.4. Work environment
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7. Product Realization
7.1. Planning of Product Realization
7.2. Customer Related Process
7.2.1. Determination of Requirements Related to the Product
7.2.2. Review of Requirements Related to the Product
7.2.3. Customer Communication
7.3. Design and Development
7.3.1. Planning
7.3.2. Input
7.3.3. Output
7.3.4. Review
7.3.5. Verification
7.3.6. Validation
7.3.7. Control of Changes
7.4. Purchasing
7.4.1. Process
7.4.2. Information
7.4.3. Verification of Purchased Product
7.5. Production and Service Operations
7.5.1. Control of Provisions
7.5.2. Validation of Processes
7.5.3. Identification and Traceability
7.5.4. Customer Property
7.5.5. Preservation of Product
7.6. Control of Monitoring and Measuring Devices
8. Measurement, Analysis and Improvement
8.1. General
8.2. Monitoring and Measurement
8.2.1. Customer Satisfaction
8.2.2. Internal Audit
8.2.3. Monitoring And Measurement Of Process
8.2.4. Monitoring And Measurement Of Product
8.3. Control of Non-conforming Product
8.4. Analysis of Data
8.5. Improvement
8.5.1. Continual Improvement
8.5.2. Corrective Action
8.5.3. Preventative Action
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Annex Title
1. Approach to QMS
2. Organization Chart
3. Master Schedule
4. Company Vision
5. Quality Principles
6. Quality Functions
7. Quality Policy
8. Quality Objectives
9. Interaction of Processes
10. Core Procedures
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1. Scope
1.1. General
This Manual specifies the Quality Management System (QMS) of ABC Pte Ltd, here
forth called ABC, the Organization or the Company.
This QMS serves many purposes and the following are some typical applications;
a. As definition of management policies with regard to Quality management,
requirements of the Organization and Customers, and relevant Authorities.
b. A complement to specified technical requirements for product and services.
c. A link to identify and satisfy the requirements and intent of both ISO 9001
Standard and ABC.
d. A base document against which practices and procedures are audited, both
internally and externally, and continually improved upon.
e. As a training document for new personnel used to ensure consistency of
performance and continuity of system when there are changes of people.
f. A main introductory document for both Customers and Supplier alike for
information purposes only.
Being a dynamic and innovative company, this QMS also serves the following special
roles
a. As a handy toolbox issued to every employee where all important tools
(procedures and practices) are readily identifiable, used and sharpened on.
b. As a strategic tool (the how) for emphasizing and achieving Company Visions
and Goals (the what).
c. A personal guidebook for effective ownership and application of policy,
objectives and procedures and other relevant quality tools.
d. As a handbook for quality for all staff to challenge and add more value to and
gain from, making it as dynamic and effective as with all other procedures and
tools.
e. An overriding point of reference on all quality issues and activities.
ABC, being a new company with phenomenal growth and performance, would expect
every manual, plan, procedure and work instruction their supporting forms and charts,
and even QMS itself, to be improved on as regularly as required to meet the ever
increasing challenges and visions.
1.2.
Application
There are no exclusions to the requirements of ISO 9001: 2000 Quality Management
Systems - Requirements.
For effective and quick reference to ISO 9001 Requirements, the Sections of the Manual
are numerically aligned with the clauses of that Standard.
The approach taken to
a.
develop
b.
implement
c.
maintain
d.
improve
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this QMS has been outlined in a simple table. By adopting such an approach, ABC intent
to create confidence in the capability of its processes and the quality of its products, and
provides a basis of continual improvement. This in turn will lead to increased satisfaction
of customers and other interested parties and to the success of the ABC.
Refer to Annex 1 : Application of QMS
2. Normative Reference
2.1. Company Profile
ABC has established presence in strategic locations in South East Asia, the Middle East
and Central Europe. Comprehensive resources and access to fabrication facilities in these
locations enables a fully responsive service to be provided to clients around the globe.
The organizational structure of the ABC can be divided into:
a.
Corporate
b.
Country
c.
Project
Refer to Annex 2 : Organization Chart, Responsibility and Authority
2.2. Scope of Services
The Quality Management System applies to the all works carried out by ABC which
include
a.
General Design Engineering
b.
Specialized Electrical & Instrumentation
c.
Project Management
d.
Fabrication and commissioning
of process equipment and systems for the oil, gas, petrochemical and associated process
industries.
3. Terms, Definitions and Abbreviations
Quality related definitions used in this Manual are according to the SS ISO 9000:2005
Quality Management Systems – Fundamentals and Vocabulary.
Other definitions are as follows:
a.
The Company / Organization – ABC Pte Ltd
b.
Senior or Top Management – person or group of people who directs and
controls an organization at the highest level
c.
Customer - Our Client/Client’s representative
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d.
Procedure Owners - custodians, authors and normally main users of
processes or procedures and work instructions and relevant supporting forms,
charts etc.
e.
Joint Audit – When two or more auditing organizations cooperate to audit a
single auditee.
f.
Combined Audit – When a QMS and other management system are audited
together. Examples include environment, safety, health and security
management systems.
g.
The term “product”, whenever used in the Manual, can also mean “service”.
Abbreviations
3.1 Title
a.
CEO
Chief Executive Officer
b.
COO
Chief Operating Officer
c.
GM
General Manager
d.
PM
Project Manager
e.
MR
Management Representative
f.
QM
Quality Manager
g.
DM
Department or Discipline Manager
3.2 System
a.
QMS
Quality Management System
b.
ABC
ABC Pte Ltd
c.
ISO
the International Organization for Standardization
d.
PQP
Project Quality Plan
e.
ITP
Inspection and Test Plan
f.
PQR
Procedure Qualification test
g.
WQT
Welder or welding operator qualification test
h.
WPR
Welder or welding operator performance record
3.3 Document Type
a.
ML
Manual
b.
PL
Plan
c.
PR
Procedures
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d.
WI
Work Instruction
e.
CF
Control Feature
f.
FM
Form
g.
OC
Organization Chart
h.
FC
Flow Chart
i.
CL
Checklist
4. Quality Management System
4.1. General Requirements
The Company QMS has been established, documented, implemented, maintained and its
effectiveness continually monitored to
a.
Satisfy ABC commitment to continuous improvement.
b.
Meet the requirements and intent of ISO 9001:2000 QMS-Requirements
c.
Meet the changing needs of the market and that of our Customers.
From QMS perspective, ABC had put in place an ongoing programme to oversee various
aspects of QMS, which includes;
1.
Assessment
2.
Training
3.
Internal Audit
4.
External Audit
5.
Management Review
6.
Document Review
a.
Manual
b.
Plans
c.
Procedures
d.
Forms
e.
Records
7.
Work Review
a.
Vendor Qualification and Surveillance
b.
Site Visits
c.
Walkabouts
d.
Others e.g. Briefing, Teambuilding, Debriefing, etc
Refer to Annex 3 : Master Schedule for QMS
ABC will continually monitor the suitability and effectiveness of this programme and the
QMS itself. Every opportunity for improvement identified, where appropriate, shall be
documented and acted on.
The organizational structure of ABC can be divided into
a.
Corporate
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b.
Country
c.
Project
The country and project organizations mirror the Corporate Organization by using
corporate procedures wherever possible. Country and Project Specific procedures and
work instructions are identified with country and project numbers respectively and are
archived accordingly.
4.2. Documentation Requirements
4.2.1. General
To lead and operate our company successfully, it is necessary to manage it in a
systematic and visible. As such, ABC has established QMS documentation in the form of
a.
Quality Manual – main and supporting policy and objective statements
b.
Plans and Procedures – core processes and activities affecting the final
product and services
c.
Work instructions – detailed instructions for various procedures
d.
Forms and Records - evidence of conformity to requirements and the
effective operation of the QMS.
Apart from the typical items above, this QMS documentation also includes
e.
Company Vision
f.
Quality Principles
g.
Quality Functions
Company Vision helps to clarify the direction of the company in both the short and long
term. At every appropriate opportunity, senior management will continually remind all
employees about our company vision. All managers shall implement this in such a way
that every employee will make it their shared vision with equal opportunity for
application, contribution and performance.
Refer to Annex 4 : Company Vision Statement
Quality Principles serve as a very critical foundation for good management and
enhanced business performance. They are:
a.
Customer Focus
b.
Leadership
c.
Involvement of People
d.
Process Approach
e.
System Approach to Management
f.
Continual Improvement
g.
Factual Approach to Decision Making
h.
Mutually Beneficial Supplier Relationship
These principles are directly adopted from ISO 9000:2005 clause 0.2.
They actually serve as a basis of the entire ISO 9000 family of standards.
The practical applications of these principles include;
a.
Policy & strategy formulation
b.
Goal & target setting
c.
Project & Operational Management
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d.
Human Resource Management
Refer to Annex 5 : Applications of Quality Principles
Quality Functions evolved over time just as standards like the ISO9000 family is being
continually revised. The basic roles of quality professionals and everyone in an
organization change in tandem with the development of quality systems, namely;
a.
Inspection
b.
Quality Control (QC)
c.
Quality Assurance (QA)
d.
Strategic Management
Attached table shows the various stages of quality evolution, beginning with one simply
for inspection to the current format which is a strategic management tool.
Other areas of change include;
a.
Primary Concerns
b.
View of Quality
c.
Emphasis
d.
Methods
e.
Role of Quality Professionals
f.
Responsibility for Quality
g.
Orientation and Approach
Refer to Annex 6 : Quality Functions
Altogether, the ownership and application of vision, principles and quality functions
throughout the company will make the “impossible dreams become (more than)
possible.” This only happens when everyone gives their full support to the Vision and
System.
4.2.2. Quality Manual
The Senior Management, MR and QM are jointly responsible for the preparation and
maintenance of this Manual. The processes needed for the QMS, their application
throughout the Company, their sequence and interaction are identified through the flow
chart and listing in Annex 8 and 9.
The Company’s QMS documentation is structured as follows:
System Manual (ML)
System Procedures (PR)
Work Instructions (WI)
Supporting Documents (CF,
FM, OC, FC & CL)
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a) Level 1: System Manual
Defines the QMS in accordance with the requirements of ISO 9001:2000. The
Quality Manual provides an overview of the QMS and associated
documentation and also documents the statements of the company’s Vision,
Quality Policy and Objectives.
b) Level 2: System Procedures
Quality System Procedures that describe the activities required to implement the
QMS based on ISO 9001:2000. They define the WHO, WHAT, HOW and
WHEN related to the activities of implementing the QMS.
c) Level 3: Work Instructions
Procedures that describe the sequence and interactive nature of the processes
necessary to ensure the conformity of services. The Work Instructions describe
the operating practices and controls of process activities performed by the
respective departments. Each department maintains their own Work Instructions
and documentation.
d) Level 4: Supporting Document
Quality records are the output of the working QMS based on ISO 9001:2000.
They demonstrate the effectiveness of the QMS and provide a means to measure
the continual improvement of its operation. They provide evidence that the
requirements for the desired quality have been met. Records can be in the form
of notes, reports, data, and completed forms etc. The originating department or
work area has primary responsibility for collating, filing, maintaining and
archiving and discarding of such records.
Refer to Annex 10 : Core Procedures
4.2.3. Control of Document
The company has established a documented procedure for controlling new and revised
documents required for the QMS. This procedure ensures that:
a.
Documents are approved for adequacy prior to release
b.
Documents are reviewed, revised and approved
c.
The current versions of documents are available at all locations where
activities are carried out
d.
Obsolete documents are removed from all points of issue or use, or are
otherwise controlled to prevent unintended use
e.
Any obsolete documents retained for legal or knowledge preservation
purposes are suitably identified
f.
All documents shall be legible and readily retrievable
g.
Applicable documents of external origin are identified and recorded
The documents can be in any form or any type of media.
Refer to Annex 10 : Core Procedures
SABC-D-PR-0100 Document Control Procedure
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4.2.4. Control of Records
The company shall establish and maintain a documented procedure for the identification,
storage, retrieval, protection and disposal of quality records. These quality records
demonstrate conformance to requirements and effective operation of the QMS.
Individual departments or functions will be responsible for the collation, maintenance and
disposal of relevant records. In general, such records are normally maintained for a
defined retention period of 5 years. However where required for legal or knowledge
retention purposes, this retention period may be longer.
Refer to Annex 10 : Core Procedures
SABC-D-PR-0300 Record Control Procedure
5. Management Responsibility
5.1. Management Commitment
Leadership, commitment and active involvement of the top management are essential for
developing and maintaining the effectiveness and efficiency of QMS to achieve benefits
for all interested parties. As such, the company Senior Management is committed to
develop, implement and continually seek to improve this QMS which in turn supports the
performance of the company to achieve the desired vision and goals.
This commitment is demonstrated through;
a.
Establishing and monitoring the company Vision, Policy and Strategic
Objectives
b.
Communicating to the staff the importance of meeting customer as well as
regulatory and legal requirements
c.
Leading by example and conducting management reviews
d.
Ensuring the availability of necessary resources for implementing and
maintaining the QMS and supporting strategic plans
e.
Regular briefings on company performance and immediate focus etc.
f.
Training on QMS throughout the company to increase awareness, motivation
and involvement. To those selected, this will lead to internal and external
audit qualifications
g.
Creating an environment that encourages the involvement and development of
people
h.
Keeping close ears on customer needs and expectations
5.2. Customer Focus
Senior Management shall ensure that customer needs, expectations and legal
requirements are identified and fulfilled to achieve total customer satisfaction.
Detailed descriptions of the activities associated with the determination of requirements
related to product and achievement of customer satisfaction are provided in Sections 7
and 8 of this manual.
Refer to Annex 5 : QMS Principles
Item 1:Customer Focus
Refer to Annex 10 : Core Procedures
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a.
b.
c.
d.
e.
f.
SABC-C-PR-0100 Tender Preparation and Contract
Review Procedure
SABC-C-PR-0500 Scheduling and Progress Reporting
Procedure
SABC-C-PR-0600 Change Identification Procedure
SABC-C-PR-0700 Technical Query Procedure
SABC-Q-PR-0300 Feedback Procedure
SABC-C-PR-0900 Satisfaction Survey Procedure
5.3. Quality Policy
The company Quality Policy defined by the CEO describes our main objectives. This
policy is used as a means of leading the company towards improvement in its
performance. The policy and QMS in turn have been carefully established to ensure that
our company can accomplish these goals.
The Senior Management shall ensure that the quality policy
a.
Is appropriate to the company
b.
Includes a commitment to comply with all requirements and continually
improve the effectiveness of the policy and QMS itself
c.
Provides a framework for establishing and reviewing quality objectives
d.
Is communicated and understood within the organization
e.
Is reviewed annually to maintain its relevance and suitability
Refer to Annex 7 : Quality Policy
5.4. Planning
Top Management shall take responsibility for quality planning of the organization. This
planning shall focus on the processes and resources needed to meet effectively and
efficiently the company’s quality objectives and requirements, consistent with the
business strategy.
5.4.1. Quality Objectives
The company Senior Management has established Quality Objectives at relevant
functions and levels within the company. The management is committed to provide the
means to achieve such goals and communicate them regularly. This is to gain from as
well as provide support to all levels.
Quality Objectives include those needed to meet the requirements of our services and
processes as well as customer requirements.
The quality objectives are consistent with the quality policy and the commitment to
continued improvement.
Typically strategic objectives are cascaded down and supported by lower level objectives
namely;
a.
Corporate
b.
Country
c.
Project
d.
Department
e.
Discipline
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These objectives shall be communicated in such a way that people in the company can
contribute to their achievement. Thus concerned parties at the various levels shall set
their own measurable objectives and monitor them accordingly. Any deviation shall be
reported and followed up accordingly. At various levels, this is discussed through
immediate superiors. At an official level, this is discussed through management review
where root causes and action required are discussed and agreed upon. These Quality
Objectives shall be reviewed annually to ensure suitability and relevance.
In general, the overriding objectives for quality are to satisfy customers by;
a.
Developing and providing services that meet their requirements by achieving
zero customer complaints
b.
Ensuring that consistency in Quality is achieved throughout the provision of
service by seeking to achieve zero non-conformity
c.
Undertaking continuous improvement of service and ensuring they are always
up-to-date and relevant
Refer to Annex 8 : Quality Objectives
5.4.2. QMS Planning
While this manual provides consistent information, both internally and externally, about
the company’s QMS, document that describe how the QMS is applied to specific product,
project or contract are referred to as Quality Plan. In any case, the Senior Management
of the Organization shall identify and define the activities and resources needed to
achieve quality objectives and to meet corporate, project and/or Customer requirements
through prompt quality planning. If necessary, the Project Quality plan and even QMS
shall be improved to achieve the quality level specified by the Customers. In both cases,
Senior Management shall ensure the integrity of the QMS is maintained when changes
are planned and implemented.
5.5. Responsibility, Authority and Communication
5.5.1. Responsibility and Authority
ABC has defined functions and their interrelations within the organization in the
Organization Charts namely for Corporate, Country and Project. This charts show the
interrelationship of functional groups that have the responsibility and authority for
performing and verifying work affecting quality.
These responsibilities and authorities are defined and communicated in order to facilitate
effective quality management.
The Organizational Structure of the Company defines the relations between the members
of the Company and shows how the authority to is executed. The overall organization
structure and provision of appropriately qualified and experienced resources to perform
the work rests at corporate and various countries lies with the CEO/COO and General
Managers respectively.
5.5.1.1.CEO/COO
The CEO and COO are the highest point of contact for the organization. They coordinate
activities to direct and control the organization at the highest level. They are responsible
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for the overall management and development of the company and the planning and
attainment of its strategic objectives.
They also establish the highest level policies, implementation strategies and goals for all
functions and business activities of all the companies under the group.
Through leadership and actions, top management can create an environment where
people are fully involved and in which a QMS can operate effectively. The quality
management principles can be used by top management as the basis of its role, which is
as follows:
a.
to establish and maintain the quality policy and objectives of the organization
b.
to promote the quality policy and objectives throughout the organization to
increase awareness, motivation, involvement and commitment
c.
to ensure focus on customer requirement throughout the organization
d.
to ensure that appropriate processes are implemented to enable requirements
of customers and other interested parties to be fulfilled and quality objectives
to be achieved
e.
to ensure that an effective and efficient QMS is established, implemented and
maintained to achieve these quality objectives
f.
to ensure the availability of necessary resources
g.
to review QMS periodically
h.
to decide on actions regarding the quality policy and objectives
i.
to decide on actions for improvement of the QMS
5.5.1.2. General Manager (GM) and Project Managers (PM)
The GM and PM are the first points of contact for the organization for specific country
or Project respectively. They are responsible for the overall management, planning and
development and attainment of their respective objectives.
They establish policies, implementation strategies and goals for all functions and business
activities for the country or project respectively.
They also assess performance and, where warranted, initiates actions with the view to
promoting ongoing improvement in service, productivity, quality and profitability.
Being senior management at specific country or project, they are responsible for
a.
Setting of country and project specific Policy & Objectives
b.
Establishing and monitoring the efficiency of the QMS and project quality
plan
c.
Develop and maintain close and trustful customer relations
d.
Assuring employment of qualified staff as per job requirements
e.
continuous improvement in performance and knowledge through on or off the
job training
5.5.1.3. Quality Manager (QM)
QM for Corporate, Country and Project will assist
a.
CEO/COO,
b.
General Managers
c.
Project Managers respectively in all quality related matters.
Collectively, they are to organize and manage the QMS in accordance with the Quality
Policy and procedures as laid down at respective levels.
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All QM have full organizational freedom to review, audit, analyze, and identify Quality
problems and to initiate corrective actions which result in solutions to and mitigation of
non-compliance problems at their respective levels.
While having direct reporting responsibility to immediate superiors, all QM have also the
direct reporting access to senior management.
Other roles include;
a.
Develop, implement, maintain and improve respective QMS
b.
Conduct QMS training for every employee within their organization
c.
Work towards ISO 9001:2000 certification and ensure ongoing compliance
d.
Review and audit to ensure that all processes, resources and products involved
conform to requirements
e.
Facilitate expeditious resolution of all findings
f.
Handle and coordinate of customers complaints
g.
Gather of all lessons learnt and quality issues at their respective levels.
h.
Partake in Vendor Evaluation and Surveillance
i.
May in serious instances, suspend a project if its continuation will have an
adverse effect on the quality objectives of company
j.
Continuous develop their own and those under them through on or off the job
training
5.5.1.4. Process Owners
Process owners are custodians, authors and main users of processes or procedures and
work instructions and relevant supporting forms, charts etc. They have full organizational
freedom to review, audit, analyze, and identify their process problems and to initiate
improvement by way investigation and revision of related processes or procedures.
This however is normally conducted in consultation with MR, QM, DM, functional
leads and those who are directly affected.
Other roles include but not limited to;
a.
Organize meetings where changes can be discussed and jointly agreed upon
b.
Revise relevant document accordingly and obtain relevant signatures
c.
Launch and provide training for relevant personnel on the objective, use and
rational of said document whenever major changes are made
d.
For minor changes, simply notify all concerned through email
e.
Periodically review all document under their charge, singularly or
collectively, to ensure their objectivity, suitability and effectiveness are
maintained.
5.5.1.5. All
Employees
Each and every employee in ABC has the organizational freedom and authority to
identify and record quality issue and opportunity in their own or related areas of work.
They shall report these directly to the process owners, DM, QM and MR.
All employees are encouraged to proactively initiate, recommend or provide solutions
and follow up actions especially in their own areas of work or expertise.
Other roles include;
a.
To proactively assist one another in achieving company vision and objectives
b.
To cooperate in all improvement efforts and quality activities
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c.
To exercise due diligence by raising of concerns and sharing of ideas ,
proposals and efforts
Refer to Annex 10 : Core Procedures
SABC-Q-PR-0200 Audit Procedure
SABC-Q-PR-0300 Feedback Procedure
5.5.2. Management Representative (MR)
ABC Senior management has appointed a Management Representative, MR at each
office. He/she, irrespective of other responsibilities, has the responsibility and authority
to
a.
Ensure the QMS is implemented and maintained in accordance with the
requirements of ISO 9000
b.
Report to the Senior management on the performance of the QMS, including
the needs for improvement
c.
Ensure awareness of Customer requirements throughout the organization
d.
Where appropriate, liaise with external parties on matters relating to the
QMS
All MR shall be given additional training in QMS so as to carry out this role effectively.
5.5.3. Internal Communication
ABC management team has established and maintained internal communication at
various levels and functions regarding the processes of the QMS and their effectiveness.
Providing such information can aid in organization’s performance improvement and
directly involves its people in the achievement of quality objectives and ultimately the
company vision.
Internal communication is currently ensured through various meetings at respective
departments. In addition, information is transmitted directly, on common drive, notice
boards, in-house journal, website, email, etc. These include, where appropriate,
a.
Memorandum on Quality policy, requirements, objectives and
accomplishments
b.
Manual, procedures, work instructions and forms and related discussion of
the same
c.
QMS training, promotions and awards
d.
Key Performance Indicators and Charts
e.
Internal and external feedbacks forum
f.
Audit notice, meeting, interview and report
g.
Relevant minutes of meetings
h.
Management briefing where senior management will brief all staff on ABC
performance, accomplishments and focus and concerns, etc.
i.
Project debriefing and lessons learnt
j.
Team building exercise, etc
5.6. Management Review
5.6.1. General
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The Management of ABC reviews the QMS at least twice a year to assess its continuing
suitability, adequacy and effectiveness. If necessary, additional reviews may be held.
The review shall evaluate the need for changes to the organization’s QMS, Quality Policy
and Quality Objectives.
5.6.2. Review Input
Agendas to Management Review shall include performance and improvement
opportunities related to the following:
a.
Results of internal and external audits
b.
Customer feedback
c.
Internal and external process performance and products conformance
d.
Status of preventive and corrective actions
e.
Follow up actions from earlier management reviews
f.
Changes that could effect the QMS
g.
Recommendations for improvement
5.6.3. Review Output
The output from the Management Review shall include actions related to:
a.
Improvement of the QMS and its process
b.
Improvement of services related to Customer requirements
c.
Resource needs.
Results of Management Reviews shall be recorded and used by senior management as
inputs for strategic planning and opportunity for performance improvement through
formulation of more challenging and rewarding objectives.
Refer to Annex 10 : Core Procedures
SABC-Q-PR-0400 Management Review Procedure
6. Resource Management
6.1. Provision of Resources
The Management of ABC is committed to provide the resources needed to:
a.
Implement and maintain the QMS and continually improve its effectiveness,
and
b.
Enhance customer satisfaction by meeting customer requirements.
Each manager is responsible for identifying the necessary resource requirements which
can include people, and processes, hardware and software, infrastructure and utility,
finance and time.
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6.2. Human Resources
6.2.1. General
People are the most valuable asset. As such the Management is committed to have a well
trained and effective work force. The organization selects competent personnel on the
basis of education, training, skill and experience and assigns tasks to the personnel with
relevant competency. As an aid to achieving its performance, ABC encourages
participation, involvement, development and commitment of its people at every level.
6.2.2. Competency, Awareness and Training
The organization provides all personnel with ongoing relevant training to maintain and
enhance their competency level, both in QMS and their own work disciplines. This is to
ensure an effective and efficient operation of the organization. As is, ABC has
established procedures to:
a.
Identify competency needs for personnel performing activities affecting
quality
b.
Provide training or take other actions to satisfy these needs
c.
Evaluate the effectiveness of the actions taken
d.
Ensure that its employees are aware of the relevance and importance of their
activities and how they contribute to the achievement of the quality
objectives
e.
Maintain appropriate records of education, experience, training and
qualifications.
f.
Support achievement of individual, team and ABC objectives
g.
Facilitate the involvement of people
As for QMS training, all employees are required to attend QMS Induction training
program in the first year and yearly refresher programme thereafter.
Refer to Annex 10 : Core Procedures
SABC-A-PR-0100 Competency, Awareness and Training
Procedure
6.3. Infrastructure
ABC is always identifying the need and requirements for new sites and work spaces in
conjunction with award of new projects, workforce changes and other such events.
ABC shall define, provide and maintain the facilities it needs to achieve the conformity
of the services, including:
a.
Work space and associate facilities
b.
Equipment, hardware and software
c.
Supporting services, such as transport or communication
For example, ABC is leasing a large workshop with even larger open spaces
and office building in Batam Indonesia as a strategic fabrication yard for
Singapore offices. Similar approach is taken in all other national offices.
6.4. Work Environment
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ABC shall identify and manage the work environment needed to
a.
achieve conformity of product requirements
b.
have a positive influence on motivation, satisfaction and performance of
people
c.
enhance the performance of the Organization
These factors include:
a.
Health and safety conditions
b.
Work methods and ergonomics
c.
Social and work ethics
d.
Conducive working conditions
As is, due to the business growth rate experienced by ABC in this region, both
Singapore and Malaysia Offices are taking newer and bigger offices. This
certainly augurs well for well being and development of the every staff and
company as a whole.
7. Product Realization
7.1. Planning of Product Realization
The product realization of the organization comprise processes of production of
drawings, fabrication, construction and installation operations on the site starting with
the design plan and the project schedule, and progressing through all stages of the project.
The sequence and interaction of these processes are defined within the respective Project
Quality Plan, which is simply another way how QMS is applied in to specific product,
project or contract.
In such planning, the organization shall determine the following, as appropriate:
a.
Quality objectives for the project or contract
b.
The need to establish processes and documentation, and provide resources and
facilities specific to the product
c.
Verification and validation activities, and the acceptance criteria
d.
The records that are necessary to provide evidences that the realization
processes and resulting product fulfilled requirements.
Dependent on the size of the project, the company translates the above points and
develops
a.
Project Management Plan
b.
Project Quality Plan
c.
Inspection and Test Plan
d.
Scheduling and Progress Reporting Procedure
Refer to Annex 10 : Core Procedures
SABC-C-PL-0200 Project Management Plan
SABC-C-PL-0300 Project Quality Plan
SABC-Q-PL-0800 Inspection and Test Plan
SABC-C-PR-0500 Scheduling and Progress Report Procedure
7.2. Customer Related Process
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7.2.1. Determination of requirements related to the product
ABC identifies customer requirements and strives to meet them. These efforts shall
consider:
a.
Requirements specified by the customer, including the requirements for
availability, delivery and support
b.
Requirements not specified by the customer but necessary for intended or
specified use
c.
Obligations related to services, including regulatory and legal requirements
d.
Additional requirements, if any, determined by the organization.
7.2.2. Review of Requirements Related to the Product
ABC reviews the identified customer requirements together with additional requirements
determined by the organization prior to the commitment to supply the product and
services to the customer. It shall ensure that:
a.
Product requirements are defined
b.
Where the customer provides no documented statement of requirement, the
customer requirements are confirmed before acceptance
c.
Contact or order requirements differing from those previously expressed in
the tender or quotation are resolved
d.
The organization has the ability to meet defined requirements.
The results of review and subsequent follow up action are recorded.
Refer to Annex 10 : Core Procedures
SABC-C-PR-0100 Tender Preparation and Contract Review
Procedure
7.2.3. Customer Communication
The organization shall identify and implement arrangements for communication with
customers relating to:
a.
Project and Product information
b.
Enquiries, contracts handling, including amendments
c.
Customer feedback, including customer complaints
Refer to Annex 10 : Core Procedures
SABC-C-PR-0500 Scheduling and Progress Reporting
Procedure
SABC-Q-PR-0300 Feedback Procedure
7.3. Design and Development
7.3.1. Planning
ABC plans and controls design and development of the product. The project plans are
drafted out before the design development and shall determine the following:
a.
Stages of design and development processes.
b.
Review, verification and validation activities to each design and
development stage
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c.
d.
e.
Responsibilities and authorities for design and development activities
Interfaces between different groups involved in design and development
Method to ensure effective communication and clarity of responsibilities at
each design and development stage.
The plans shall be updated, as appropriate, as the design and development progresses.
7.3.2. Input
The design inputs come from customer requirements and regulatory requirements. The
inputs shall be defined and documented in the in the project and development plan. These
include:
a.
Functional and performance requirements
b.
Applicable information regulatory and legal requirements
c.
Applicable information derived similar designs
d.
Any other requirements essential for design and development.
These inputs shall be reviewed for adequacy. Incomplete, ambiguous or conflicting
requirements shall be resolved.
7.3.3. Output
The outputs of the design and development processes shall be documented in a format
that enables verification against the design and development inputs. Design and
development output shall:
a.
Meet the design and development input requirements
b.
Provide appropriate information for production and services operations
c.
Contain or reference product acceptance criteria
d.
Defined the characteristics of the product that are essential to its safe and
proper use.
Design and development and development output documents shall be approved prior to
release.
7.3.4. Review
Throughout the products development process, design reviews shall be conducted to
verify the design and development. The objectives of the design reviews are:
a.
Evaluate the ability to fulfilled requirements
b.
Identify problems and propose follow up actions.
Participants in the design reviews shall include representatives of functions concerned
with the design and development stages being reviewed. The results of the design reviews
and subsequent follow up actions shall be recorded.
7.3.5. Verification
Design and development verification shall be performed to ensure the design and
development output meets the design and development inputs. The results of the
verification and subsequent follow up actions are recorded.
7.3.6. Validation
Design and development validation is performed to confirm that resulting product is
capable of meeting the requirements for the intended use.
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Where applicable validation shall be completed prior to the delivery or implementation of
the product.
Where it is impractical to perform full validation prior to delivery or implementation,
partial validation shall be performed to the extent applicable.
The results of the validation and subsequent follow up actions shall be recorded.
Refer to Annex 10 : Core Procedures
SABC-G-PR-0100 Design and Development Procedure
7.3.7. Control of Changes
Design and development changes or modifications shall be approved by authorized
personnel and recorded before implementation.
Design planning, design output, design verification, and design validation activities
follow the same process that was applied to the original design. The results of the review
of changes and subsequent follow up actions shall be recorded.
Refer to Annex 10 : Core Procedures
SABC-C-PR-0600 Change Identification Procedure
SABC-C-PR-0700 Control of Technical Queries
7.4. Purchasing
7.4.1. Process
ABC control its purchasing processes to ensure purchased products/ services conform to
requirements. The type and extent of control is dependent upon the effect of the
purchased products on the final product.
The organization evaluates and selects suppliers based on their ability to supply product/
services in accordance with the organization’s requirements. The criteria for selection and
periodic evaluation are established. The results of evaluations and follow-up actions shall
be recorded. The criteria for supplier selection include certification to ISO9001:2000,
technical competency and commercial risk.
Refer to Annex 10 : Core Procedures
SABC-Q-PR-0500 Supplier Assessment Procedure
7.4.2. Information
ABC purchasing documents shall contain information describing the products/ services to
be purchased, including where appropriate:
a.
Identification of the materials, goods, or services being ordered
b.
Requirements for approval or qualification of products/ services,
procedures, processes, equipment and personnel.
c.
Reference specifications or applicable standards
d.
Quality management system requirements
The organization shall ensure the adequacy of specified requirements contained in the
purchasing documents prior to their release.
Refer to Annex 10 : Core Procedures
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SABC-C-PR-0400 Purchasing Procedure
7.4.3. Verification of Purchased Product
ABC verifies the purchased products and services to ensure that they confirm to be
specified requirements.
Where the organization or its customer proposes to perform verification activities at the
supplier’s premises, the organization shall specify the intended verification arrangements
methods of products release in the purchasing documents.
Refer to Annex 10 : Core Procedures
SABC-O-PR-0100 Production and Service Procedure
7.5. Production and Service Provision
7.5.1. Control of Provisions
ABC controls of production and service operations through:
a.
The availability of information that specifies the characteristics of the
product.
b.
Where necessary, the availability of work instructions.
c.
The use and maintenance of suitable equipment.
d.
The availability and use of monitoring devices.
e.
The implementation of defined processes for release, delivery and
applicable post delivery activities.
The company ensures that fabrication, construction and installation requirements are
defined. This is either documented in contract, directives or technical specifications.
Project managers are responsible for ensuring that technical data including drawings,
datasheets and standards specifications available to users are complete, unambiguous
complete with schedule for completion.
Production on the other hand must ensure that all tools and measuring equipments used
are maintained and suitable for intended use.
The overall production and service activities performed are controlled by mean of
Inspection and Test Plan (ITP) where key stages of intervention of production and
services are agreed upon among company and customer representatives. This plan
include reference standards and codes, work instruction and acceptance criteria for
processes, tests, inspections and customer’s points of involvement which include hold,
witness, monitor, review or information only.
7.5.2. Validation of Processes
ABC shall validate the production processes where the resulting output cannot be verified
by subsequent measurement or monitoring. This includes any processes where
deficiencies may become apparent only after the product is in use or has been delivered.
The validation of processes is to evaluate the ability of the processes to achieve planned
results.
The arrangements for validation shall be defined and include the following:
a.
Qualification of processes
b.
Qualification of equipment and personnel
c.
Use of defined methodologies and procedures
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d.
Requirements for records
e.
Re-validation
These include welding process where the level of qualification of personnel and process
are validated by initial inspection and tests.
E.g. welding procedure qualification tests (PQT) are carried out to identify
welding procedure specifications (WPS). Similarly, welder and welding operator
go through welder or welding operator qualification test (WQT). Their
performances are further monitored through welder performance record (WPR)
to ensure consistent results.
All these are normally carried out with the attendance of third party and proper
report and records as according to codes and standards such that they are
recognized by other interested parties.
7.5.3. Identification and Traceability
ABC identifies, where appropriate, the product by a unique identification system
throughout the production realization, from material receipt to all stages of fabrication,
construction and installation. This includes work carried out by the company and
suppliers where the extent of which is spelt out in relevant codes, standards and customer
or company specifications or requirements.
The organization shall identify the status of the product with respect to measurement and
monitoring requirements, in accordance to relevant Inspection and Test Plan (ITP).
The organization shall control and record the unique identification of the product, where
traceability is a requirement. In general this relates to the criticality of the process with
regards to applications and locations.
Typically structural integrity is categorized as by special, primary and secondary
areas, where the level of inspection, test and traceability reduces accordingly.
In any case the records should be consistent such that progress can be summarized
and reported effectively. E.g. welding and material traceability summary where
relevant information on welding and material are updated as work progresses and
finally issued are part of construction deliverables.
7.5.4. Customer Property
ABC exercises care with customer property while it is under the organization’s control or
being used by the organization. The organization shall identify, verify, protect and
maintain Customer property provided for use of incorporation into the product.
In the event where the Customer property is lost, damaged or otherwise found to be
unsuitable for use, the situation shall be recorded and reported to the customer.
All free issue materials required for the fabrication, construction and installation will be
verified, identified, stored and controlled through a master list similar to those that
company purchased.
7.5.5. Preservation of Product
ABC shall preserve conformity of products with Customer requirements during storage,
internal processing and delivery to the intended destination by proper identification,
handling, packaging, storage and protection. Where required, the methods of preservation
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shall be documented. At appropriate intervals, the condition of product or constituent
parts in stock shall be assessed.
7.6. Control of Monitoring and Measuring Devices
ABC shall determine the monitoring and measurement to be made and the measuring and
monitoring devices required to assure conformity of product to specified requirements.
Measuring and monitoring devices shall be used and controlled to ensure that
measurement capability is consistent with the measurement requirements.
Where applicable, measuring and monitoring devices shall:
a.
Be calibrated and adjusted periodically or prior to use, against devices
traceable to international or national standards; where no such standards exist,
the basis used for calibration shall be recorded;
b.
Be safeguarded from adjustments that would invalidate the calibration;
c.
be protected from damages and deterioration during handling, maintenance
and storage;
d.
Have the results of their calibration recorded;
e.
Have the validation of previous results re-assessed if they are subsequently
found to be out of calibration, and corrective action taken.
Software used for measuring and monitoring of specified requirements shall be validated
prior to use.
Refer to Annex 10 : Core Procedures
SABC-O-PR-0100 Production and Service Procedure
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8. Measurement, Analysis and Improvement
8.1. General
ABC plans and implements the monitoring, measurement, analysis and improvement
processes needed to:
a.
Demonstrate conformity of the product
b.
Ensure conformity of the QMS
c.
Continually improve the effectiveness of the QMS
As measurement data is important to fact based decision making, senior management
shall ensure effective and efficient measurement, collection and validation of data to
monitor and ensure
a.
organization’s actual performance
b.
satisfaction of interested parties
Departmental Managers are responsible for identifying the need for using appropriate
statistical technique within their own areas. Examples of statistics would include
performance on quality objectives. Such analysis will be used as input in management
review.
Refer to Annex 8 : Quality Objectives
Refer to Annex 10 : Core Procedures
SABC-Q-PR-0400 Management Review Procedure
8.2. Monitoring and Measurement
8.2.1. Customer Satisfaction
ABC monitors information on customer satisfaction as a vital measurement of
performance of the QMS. Customer satisfaction information is obtained from customer
survey which includes their perception on
a.
Audit results
b.
Inspection Reporting
c.
Responsiveness to Client requests
d.
Expeditious resolution of problems
e.
Close out of NCR, CA and PA
f.
Repair rates
g.
Technical knowledge
h.
On time / on budget / Compliance with requirements
Project managers shall obtain such information on a quarterly basis by either
a.
Solicited Customer Satisfaction Questionnaire
b.
Follow up telephone call
c.
Personnel interview
QM will collate such information for analysis and use as input for management review.
Refer to Annex 10 : Core Procedures
SABC-C-PR-0900 Satisfaction Survey Procedure
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8.2.2. Internal Audit
ABC Senior Management ensures the effective and efficient internal audit processes to
assess the strengths and weaknesses of QMS and ABC. Internal audit acts as a
management tool for independent assessment by obtaining objective evidences and
conclusions. As such Senior Management shall grant the authority to manage the audit
programme. Those assigned the responsibility shall
a.
Establish, implement, monitor, review, improve the audit programme
b.
Identify necessary resources and ensure they are provided
ABC conducts internal audits at planned intervals to determine whether the QMS
a.
Conforms to the planned arrangements, to the requirements of ISO
9001:2000 Standards and ABC
b.
Is effectively implemented and maintained.
The organization plans the audit programme taking into consideration the status and
importance of the activities and areas to be audited as well as the results of previous
audits.
As a general guide, ABC will audit every project at a quarterly basis key processes and
procedures relevant at that point of time.
Refer to Annex 3 : Master Schedule
Item 3 Internal Audit
The audit criteria, scope and methods are defined in audit notice while the frequency is
spelt out in the QMS master schedule. The responsibilities and requirements for
conducting audits, ensuring their independence, recording results and reporting to
management are documented in audit report.
Audits are performed by personnel other than those who performed the work being
audited. QM, where necessary, will appoint internal auditors and technical experts, while
he serves as lead or sole auditor.
The management responsible for the area being audited shall ensure that actions are
being taken without undue delay to eliminate detected non conformities and their causes.
As a guideline, the response time for acknowledgement and follow up on proposal and
conclusion are two weeks consecutively.
Conclusion shall include the verification of the implementation of action and the
reporting of verification results.
Whenever required, additional internal audits are performed to investigate specific
problem areas and/or to follow up on major findings. These may be initiated on short
notices by either auditee or auditor.
Refer to Annex 10 : Core Procedures
SABC-Q-PR-0200 Audit Procedure
SABC-Q-PR-0300 Feedback Procedure
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8.2.3. Monitoring And Measurement Of Processes
The organization measures and monitors process necessary to meet customer
requirements. Many of the processes are measured through quality objectives, audit and
assessment. The intent is to demonstrate the ability of the processes to achieve planned
results. During periodical survey, a more independent source of such information would
be actual ratings and opinions given by
a.
Employees
b.
Customers
c.
Suppliers
When planned results are not achieved, correction and corrective action shall be taken, as
appropriate, to ensure conformity of the product.
8.2.4. Monitoring And Measurement Of Product
The organization monitors and measures the characteristics of products to verify that the
product requirements are fulfilled. This is carried out at appropriate stages of product
realization process in accordance with the planned arrangements.
This requirement is addressed mainly in projects where inspection and test plans (ITP)
are generated. Evidence of conformity with the acceptance criteria shall be maintained.
Records shall indicate the person authorizing the release of product. Degree and type of
involvement of Customers and Certifying body are agreed upon upfront during the
project planning stage of product realization.
Agreed intervention points at various stages of product realization process would include
a.
Hold
b.
Witness
c.
Monitor
d.
Review
e.
Information only
Products do not proceed or are not dispatched until specified activities have been
satisfactorily completed and the related documentation is available and authorized. The
only exception is when services are released with full traceability through end use, thus
allowing for positive recall.
Personnel other than the persons who perform or directly supervised the production of the
products shall perform final acceptance and product release.
Refer to Annex 10 : Core Procedures
SABC-Q-PL-0600 Inspection and Test Plan
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8.3. Control of Nonconforming Product
The organization ensures that product which does not conform to requirements is
identified and controlled to prevent unintended use or delivery.
The organization shall deal with nonconformity product by taking action to eliminate the
detected nonconformity.
Records of the nature of nonconformities and any subsequent actions taken shall be
maintained.
When nonconforming product is corrected, it shall be subject to re-verification to
demonstrate conformity to the requirements.
When nonconforming product is detected after delivery, the organization shall recall the
product for corrective action or rectify the problem on site.
Any information on rework, especially for field work, shall be documented likewise and
used as case study during debriefing and/or MR input. This is especially because the
impact on cost, schedule and reputation of such incidences are exceptionally high.
For example, welding defects are not considered as NCR as it is considered as
work-in-progress, unless the corrective work is not carried out or the trend on the
amount of defect is exceptionally high. Nonetheless, ABC consider such
information as useful for monitoring and improving performance and bottom line.
At ABC, every employee is empowered with the authority and responsibility to report
nonconformities at any stage of a process in order to ensure timely detection and
disposition of nonconformities. In fact, ABC also welcome Customers, Suppliers and
third parties to raise issues through this mechanism. Responsible managers shall
acknowledge and follow up accordingly without undue delay. Quality manager will
facilitate the tracking and prompting of such matters.
Refer to Annex 10 : Core Procedures
SABC-Q-PR-0300 Non Conformance Report Procedure
8.4. Analysis of Data
ABC collects and analyse appropriate data from all parts of the company to determine the
suitability and effectiveness of the QMS and to identify improvement opportunities.
The organization analyzes applicable data to provide information on:
a.
Customer satisfaction
b.
Conformance to Customer requirements
c.
Characteristics of process, services and their trends
d.
Suppliers
This is normally done within the framework of Management Reviews. MR, QM and DM
are jointly responsible for compiling and analyzing different input data.
Ultimately decisions making requires reliable analysis of data, balanced with experience
and intuition.
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8.5. Improvement
8.5.1. Continual Improvement
The organization plans and manages the process necessary for the continual
improvements of the QMS through:
a.
Quality policy and objectives
b.
Audits results
c.
Analysis of data
d.
Corrective and preventive actions
e.
Management review
Every employee, customer and even supplier are encouraged to proactively suggest
new ideas for improvement of processes, products and services, especially within their
own areas of work or expertise. Nonetheless proposal from other disciplines and sources
are also welcome. These improvements may result in changes of product and processes
and even the QMS itself.
QM will facilitate the tracking and prompting of such matters.
8.5.2. Corrective Action
ABC takes appropriate corrective action to eliminate the cause of nonconformities in
order to prevent recurrence.
The organization has established a documented procedure for corrective actions which
includes:
a. Identifying nonconformities (including Customer complaints)
b. Determining the cause of nonconformity
c. Evaluating the need for actions to ensure that non-conformities do not recur
d. Determining and implementing the corrective action needed.
e. Recording results of action taken
f. Reviewing results of action taken
8.5.3. Preventative Action
ABC has established a procedure to eliminate the causes of potential nonconformities and
to prevent occurrence.
This documented procedure defines the requirements for:
a. Identifying potential nonconformities and their causes
b. Determining and ensuring the implementation of preventive action needed
c. Recording results of action taken
d. Reviewing of preventive action taken.
Refer to Annex 10 : Core Procedures
SABC-Q-PR-0200 Feedback Procedure
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This Feedback procedure addresses partly or wholly the following clauses
No
Clauses
Title
a.
5.5.1
Internal Communication
b.
7.2.3
Customer Communication
c.
8.3
Control of Nonconforming Product
d.
8.5.1
Continual Improvement
e.
8.5.2
Corrective Action
f.
8.5.3
Preventive Action
How much time, effort, scope and depth we collectively and singularly put into the
development and performance of QMS and ABC is how much we can expect to gain
from.
Likewise, how much a company can afford to tend to the needs and expectations of its
suppliers, customers and employees depends on how much they as individuals tends and
contribute to company performance, bottom line and growth, and vice versa.
What’s worse than training your people and losing them? Not training them and
keeping them. As such let’s work together to develop one another through QMS
for the benefit and satisfaction of the company and all involved.
End of Manual
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