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TSA Info Services QMS - Section 02 - MR-DC_TSA_Manual
TSA Info Services QMS - Section 02 - MR-DC_TSA_Manual
TSA Info Services QMS - Section 02 - MR-DC_TSA_Manual
Email: india@tsainfo.com
Web site: https://www. tsainfo.com
Initial Release of
01 00 01/01/2020 Diala D Paine Okay
Document
LIST OF ABBREVIATIONS
2 QP Quality Policy
3 QO Quality Objectives
4 PO Process Objectives
6 DC Document controller
INDEX
1 Scope
3 NOT Applicable
5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Establishing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and Services
8.2.1 Customer communication
8.2.2 Determining the requirements for products and services
8.2.3 Review of the requirements for products and services
8.2.4 Changes to requirements for products and services
8.3 Design and development of products and services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of nonconforming outputs
9 Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer Satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
Appendix
List of Procedures
List of Policies
COMPANY PROFILE
TSA Info Services is a fully integrated global payroll, PEO and HR services provider. This means that as
our client you get access to our cutting-edge global payroll software, local in-country payroll, compliance
and HR specialists, tax and HR advisory service entirely without having to deal with the complexities of
setting up local legal entities or in-house payrolls.
If you are tired of dealing with the payroll industry dinosaurs and their outdated and inflexible technology, or
with aggregators who simply pass on your data to their subcontractors and divert your calls to an off-shore
call center and never seem to have the local knowledge, TSA Info services is your ideal partner.
Our in-country payroll and PEO specialists support you locally when and where you need them. We
provide you with practical guidance regarding payroll compliance issues as well as immigration and HR.
Never again you will be left hanging, waiting for an answer from a call center. We take care of your
business when and where you need it.
Our recruitment consultants have extensive experience placing candidates across various industries and
organizational levels. TSA Info services works for leading multinationals, conducting the most sophisticated
executive searches, and spearheaded large-scale recruitment process outsourcing and mobilization
projects involving thousands of candidates. We tailor each recruitment project to match your exact
requirements and budget.
TSA info services has its Headquarter (Middle East and North Africa - MENA) based in Anytown, In India
also they are present in Gurgaon and supports for their scope activity
Total number of employees is 425. Including 200 contract employees (working for 8 Hours per day and 6
days per week). There is only general shift in this organization.
Benefits of Payroll Outsourcing - Time Saving, Reduces Cost, avoids any revenue penalties, Spare the
entrepreneur to stay updated about the rules and regulations, Direct transfer of money and easy access of
pay slips, Enhanced Security.
Warehouse - sufficient free space is needed to operate a warehouse effectively. When planning the size of
a warehouse considered, planning on having about 70-80% utilization of available space, whilst
considering: throughput rate, number of stock keeping units (SKU), handling characteristics of items, etc.
Departments in this organization are Management, HR, Quality, Purchase, Warehouse, Design and
Development, Store, Accounts, Maintenance and Document controller (DC) / Management Representative
(MR).
INTRODUCTION
0.1 General
General Requirements
▪ TSA Info services has established, implemented & maintained to meet the requirements of
ISO 9001:2015 Quality Manual.
▪ TSA Info services plans and manages these processes in accordance with the PDCA
model of improvement.
▪ Process Approach is being deployed and all Business Processes of TSA Info services are
being analyzed by respective Manager considering Process Analysis method
▪ Risk assessment & effect on interested parties is also being assessed and accordingly
PDCA cycle is being defined, established and implemented.
▪ Procedures and Policies have been identified for implement effective implementation of
QMS system.
The adoption of a quality management system is a strategic decision for an TSA Info services
that can help to improve its overall performance and provide a sound basis for sustainable
development initiatives.
The potential benefits to an TSA Info services of implementing a quality management system
based on this Quality Manual are:
a) The ability to consistently provide products and services that meet customer and
applicable
b) Statutory and regulatory requirements;
c) Facilitating opportunities to enhance customer satisfaction;
d) Addressing risks and opportunities associated with its context and objectives;
e) The ability to demonstrate conformity to specified quality management system
requirements.
This Quality Manual can be used by internal and external parties. It is not the intent of this Quality
Manual to imply the need for:
▪ Uniformity in the structure of different quality management systems;
▪ Alignment of documentation to the clause structure of this quality manual;
▪ The use of the specific terminology of this quality manual within the TSA Info services.
The quality management system requirements specified in this Quality Manual are
complementary to requirements for products and services.
This Quality Manual employs the process approach, which incorporates the Plan-Do-Check-Act
(PDCA) cycle and risk-based thinking.
The process approach enables an TSA Info services to plan its processes and their interactions.
The PDCA cycle enables an TSA Info services to ensure that its processes are adequately
resourced and managed, and opportunities for improvement are determined and acted on.
Risk-based thinking enables an TSA Info services to determine the factors that could cause its
processes and its quality management system to deviate from the planned results, to put in place
preventive controls to minimize negative effects and to make maximum use of opportunities as
they arise (see Clause A.4).
Consistently meeting requirements and addressing future needs and expectations poses a
challenge for TSA Info services in an increasingly dynamic and complex environment. To achieve
this objective, TSA Info services might find it necessary to adopt various forms of improvement in
addition to correction and continual improvement, such as breakthrough change, innovation and
re-organization.
This Quality Manual is based on the quality management principles described in ISO 9000. The
descriptions include a statement of each principle, a rationale of why the principle is important for
the TSA Info services, some examples of benefits associated with the principle and examples of
typical actions to improve the TSA Info services’ performance when applying the principle. The
quality management principles are seven principles:
▪ Customer focus;
▪ Leadership;
▪ Engagement of people;
▪ Process approach;
▪ Improvement;
▪ Evidence-based decision making;
▪
0.3.1 General
▪ This Quality Manual promotes the adoption of a process approach when developing,
implementing and improving the effectiveness of a quality management system, to
enhance customer satisfaction by meeting customer requirements. Specific requirements
considered essential to the adoption of a process approach are included in 4.4.
The process approach involves the systematic definition and management of processes, and
their interactions, so as to achieve the intended results in accordance with the quality policy and
strategic direction of the TSA Info services. Management of the processes and the system as a
whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based
thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable
results.
Figure 1 gives a schematic representation of any process and shows the interaction of its
elements. The monitoring and measuring check points, which are necessary for control, are
specific to each process and will vary depending on the related risks.
Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management
system. The concept of risk-based thinking has been implicit in previous editions of this Quality
Manual including, for example, carrying out preventive action to eliminate potential non-
conformities, analyzing any non-conformities that do occur, and taking action to prevent
recurrence that is appropriate for the effects of the nonconformity.
To conform to the requirements of this Quality Manual, an TSA Info services needs to plan and
implement actions to address risks and opportunities. Addressing both risks and opportunities
establishes a basis for increasing the effectiveness of the quality management system, achieving
improved results and preventing negative effects.
Opportunities can arise as a result of a situation favorable to achieving an intended result, for
example, a set of circumstances that allow the TSA Info services to attract customers, develop
new products and services, reduce waste or improve productivity. Actions to address
opportunities can also include consideration of associated risks. Risk is the effect of uncertainty
and any such uncertainty can have positive or negative effects. A positive deviation arising from a
risk can provide an opportunity, but not all positive effects of risk result in opportunities.
This Quality Manual applies the framework developed by ISO to improve alignment among its
Quality Manuals for management systems (see Clause A.1). This Quality Manual enables an
TSA Info services to use the process approach, coupled with the PDCA cycle and risk-based
thinking, to align or integrate its quality management system with the requirements of other
management system Quality Manuals.
This Quality Manual relates to ISO 9000 and ISO 9004 as follows:
▪ ISO 9004 Managing for the sustained success of an TSA Info services — A quality
management approach provides guidance for TSA Info services that choose to progress
beyond the requirements of this Quality Manual.
Annex B provides details of other Quality Manuals on quality management and quality
management systems that have been developed by ISO/TC 176.
This Quality Manual does not include requirements specific to other management systems, such
as those for environmental management, occupational health and safety management, or
financial management. Sector-specific quality management system Quality Manuals based on
the requirements of this International Quality Manual have been developed for a number of
sectors. Some of these Quality Manuals specify additional quality management system
requirements, while others are limited to providing guidance to the application of this Quality
Manual within the particular sector.
TSA INFO SERVICES has adopted International Standard, ISO 9001:2015 specifying the
requirements for a Quality Management System in order to:
▪ Demonstrate its ability to consistently provide services to meet customer’s applicable
statutory and regulatory requirements.
▪ Enhance customer satisfaction through the effective application of the system, including
the processes for continual improvement of the system and the assurance of conformity to
customer and applicable statutory & regulatory requirements.
The established system is applicable to all the activities followed in the organization.
This Quality Management System Manual is prepared to comply with the requirements of the
international quality management system standard ISO 9001:2015
The Purpose of this Quality manual is to clearly identify and describe the following:
▪ The Organization Core and Supporting Business processes.
▪ Commitment to Customers, Quality and Continual Improvement.
▪ The Sequence and Interaction between processes.
▪ The methods for planning and controlling process activities and related documentation.
▪ Responsibilities and Authorities.
▪ Structure of Quality System Documentation.
▪ Relevant ISO 9001 requirements.
The manual is also designed to provide an introduction and reference for Customer,
Management and Staffs.
Figure 1 Representation of the structure of this International Standard in the PDCA cycle
Key
Value - adding activities
Information flow
3. Not Applicable
TSA INFO SERVICES has established, documented, implemented & maintains a QMS to
continually improve the effectiveness in accordance with the requirements of ISO 9001:2015
international standard.
Document References:
▪ Interested Parties issues -
TSA INFO SERVICES has committed to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements
Customer Services:
▪ Maintain and improve response times committed to the customers with a view to improve
customer service.
▪ Improve process and service capabilities of the department staff through continuous
training and education programmes every year to keep them abreast of latest
technologies.
▪ Achieve and maintain the training and certification levels for all staff as per the
requirements of the principals and the business.
The organization shall monitor and review information about these interested parties and their
relevant requirements.
Document References:
▪ Interested Parties needs and expectation
This section describes the structure of the quality management system which is established,
documented, implemented and maintained by the organization and which is continually reviewed
to improve its effectiveness in accordance with the requirements of ISO 9001:2015 standard. The
scope of TSA INFO SERVICES quality management system applies to the process of “General
Trading – Payroll Outsourcing, Employee Outsourcing” provided by the organization. The
quality system documented in this manual applies to all departments and activities of the
organization.
Document References:
▪ TSA info Services Scope -
4.4.1.1 TSA INFO SERVICES’s Quality Management System is based on the seven quality management
principles emphasized by the ISO 9001:2015 standard to enable a continual improvement in our
overall efficiency in responding to and meeting the customer requirements and expectations as
follows:
TSA INFO SERVICES depends on customers and therefore realizes the importance of
understanding the customer requirements. TSA INFO SERVICES is committed to understanding,
anticipating and responding to customers’ requirements with reputed products and service
excellence.
b) Leadership
TSA INFO SERVICES strongly believes in leadership by establishing unity of purpose & direction
and by creating the environment in which all staff can become fully involved in achieving TSA
INFO SERVICES objectives.
Team spirit is considered to be the essence of all activities and processes within TSA INFO
SERVICES. TSA INFO SERVICES maintains an environment in which every employee is a team
member and encourages participation of all staff through regular meetings and feedback
sessions to achieve the organization’s goals.
d) Process approach
All activities in TSA INFO SERVICES are conducted through processes which are well managed,
are well documented in the Quality Management System - Operating Procedures and are
controlled, monitored, and periodically reviewed. All processes are mapped with special
consideration to inputs, outputs, interfaces, resources, costs and time factors to achieve efficient
and effective operations at all levels.
e) Improvement
Decision making at TSA INFO SERVICES is based on the logical analysis of data and
information to ensure effective decisions.
g) Relationship Management
TSA INFO SERVICES has established mutually beneficial relationships with all its interested
parties such as suppliers to enhance its ability to create value for the customers. Suppliers are
treated as TSA INFO SERVICES strategic partners in business.
4.4.1.2 The quality management system documented in this manual at relevant sections and the
interaction matrix: (a) Determines the processes needed for the quality management system and
their application throughout the organization, (b) determines the sequence and interaction of
these processes, (c) determines criteria and methods needed to ensure that both the operation
and control of these processes are effective, (d) ensures the availability of resources and
information necessary to support the operation and monitoring of these processes, (e)
establishes methods for monitoring, where applicable measurement and analysis of these
processes, and (f) enables implementation of actions necessary to achieve planned results and
improvement of these processes. All the processes are controlled and managed by documented
procedures / instructions in accordance with the requirements of ISO 9001:2015 standard.
4.4.1.3 Certain NOT APPLICABLE are made under this quality management system from the
requirements of ISO 9001:2015 standard which are detailed under Sections of this manual with
justifications for such NOT APPLICABLE. Such NOT APPLICABLE are limited to the
requirements of Clauses of the ISO 9001:2015 standard as they do not apply due to the nature of
TSA INFO SERVICES ‘s business. These exclusions do not affect TSA INFO SERVICES ability
or responsibility in any way to provide products that meet customers’ and regulatory
requirements.
4.4.1.4 Any processes outsourced to sub-contractors like site preparatory works, networking passive
equipment shall be subject to the controls through purchasing process and relevant and
monitoring as applicable to TSA INFO SERVICES ‘s own processes carried out within the
organization.
5. Leadership
The Management is committed to the ongoing maintenance and improvement of the quality
management system. To ensure this, management focuses on deploying practical steps that
concretely support the Quality Policies and Quality Objectives
▪ Empowerment
All employees are empowered to submit requests for corrective action to affect change and
improve the company and its processes and their own experience at the company. All employees
are empowered to stop production when nonconformities are encountered.
▪ Intelligent management
We aim to ensure that management makes decisions based on facts, data and evidence. To do
this, management has established quality objectives for all processes. The internal audit process
relies on the recording of verifiable data as a means of driving corrective actions as well as
improvement efforts.
By conducting periodic management reviews of the quality system, management ensures the
overall effectiveness of the quality system.
▪ Workplace excellence
We ensure the work environment and facilities and atmosphere are best in class through
management understanding and review of resource requirements and through ongoing
communication with employees regarding the workplace.
5.1.2.1 With the overall aim of achieving and enhancing customer satisfaction, TSA INFO SERVICES top
management shall ensure that:
a) Customer requirements and expectations are properly determined and are converted into
appropriate product requirements and specifications,
b) Customer requirements are adequately understood and are met as agreed upon or
committed,
c) Organization’s capabilities with respect to contractual requirements and commitments are
suitably ascertained, and
d) Customer satisfaction is enhanced through all possible and commercially reasonable
means.
5.1.2.2 This is made possible by establishing and observing adequate procedures, policies and
objectives. Competent human resources are made available in the organization to add quality to
all activities, which contribute to achieve customer satisfaction. Responsibilities and authorities
are clearly defined and delegated to various levels of staff and team spirit is emphasized in every
activity, function and department.
A Quality Policy is defined for the organization by the CEO as described in this manual. Top
management is responsible to ensure that the established quality policy:
a) Is appropriate for the purpose of the organization and its customers,
b) Includes a commitment to comply with requirements and to continually improve the
effectiveness of the quality management system,
c) Provides a framework for establishing and reviewing quality objectives,
d) Is communicated, understood and implemented throughout the organization by all levels of
employees to ensure their commitment, and
e) Is regularly reviewed for continuing suitability.
Document References:
▪ Quality Policy
Top management has defined the following key responsibilities and authorities for effective
implementation of the quality management system. Detailed job responsibilities and authorities
are defined in the Job Descriptions which are communicated to the employees concerned, and
also in the work instruction.
Document References:
▪ Job Description
6. Planning
Quality system planning is carried out by the management to establish processes, procedures
and responsibilities to deliver the services and products required by customers. Jobs and skills
planning is based upon the business awarded by the customers and is taken care of by
responsible staff.
c. Identification and acquisition of any resources and skills that may be required to achieve
the desired quality,
d. Identification of suitable verification activities at appropriates stages and the criteria and
methods needed to ensure their effectiveness in the realization of quality,
e. Identification and preparation of suitable quality records needed,
f. Obtaining feedback from customers and identifying & applying other suitable methods for
monitoring, measurement and analysis of processes, and
g. Implementing necessary actions to achieve planned results and continual improvement.
Document References:
▪ Business Risk and Opportunities
In order to achieve the objectives of the quality policy, quality objectives are established by top
management, including those needed to meet product / service requirements at relevant
functions and levels within the organization. The overall quality objective of the organization is to
achieve growth through continued customer satisfaction by fulfilling customer requirements and
eliminating non-conformances at all stages. The management considers the importance of
setting quality objectives for various functions, which are measurable, are consistent with the
stated quality policy and are aimed at continual improvement. The achievement of these
objectives is reviewed periodically as part of the management review process and necessary
corrective actions are initiated, as required. Quality objectives may be changed; revised and / or
new quality objectives may be set, as necessary.
Document References:
▪ Quality Objectives
▪ The quality management system was planned in advance and its documented policies and
procedures were reviewed prior to implementation. Management ensures that QMS is maintained
when changes to the QMS are planned and implemented. Subsequent major changes that may
affect the performance, quality or reliability of the product will be identified, reviewed and
approved and the QMS documentation will be updated.
▪ The QMS documentation acts as the overall quality plan for the company. As required,
specific quality processes may be developed for individuals; these plans include the information
given above. In such cases, the CEO has overall responsibility for the development of quality
plans. Collecting management review information.
Document References:
▪ Change plan
7. Support
7.1 Resources
7.1.1 General
7.1.2 People
During Management review, the company’s management determines and provides the resources
needed to implement and maintain the quality management system and continually improve its
effectiveness. The processes of Management and Proposal Development and Contract Review
have been developed to enhance customer satisfaction by meeting customer requirements and
exceeding customer expectations. All employees may also submit requests for corrective action
regarding other resources needs or issues.
All the employees are selected trained and evaluated to ensure that those personnel performing
work affecting conformity to product requirements both directly & indirectly are competent on the
basis of appropriate education, training, skills and experience. As required, personnel undergo
training to develop or improve these abilities.
Detailed Job descriptions are defined by the management detailing designations, job
responsibilities, general education and experience required for all job positions based on
competence required for each job category. Job Descriptions are available with the respective
Department Heads and copies thereof are also maintained in the employee personnel files. Job
Descriptions form the basis of recruitment, transfers, promotions and training of personnel.
7.1.3 Infrastructure
TSA INFO SERVICES determines, provides and maintains the infrastructure needed by all
departments and staff to achieve conformity to product and service requirements, which include:
a) Building/workspace and associated facilities and utilities such as furniture, air conditioning,
electricity, water and adequate facilities / space for storage of products.
b) Process equipment such as hardware, software, tools, and office equipment and computer
networks.
c) Supporting services such as vehicles for transport, where required and communication
facilities (telephone, fax, internet, email, mobile phones etc.).
The organization determines and manages those human and physical factors of the work
environment needed to achieve conformity to product and service requirements, which include
health and safety conditions, work procedures/methods/instructions, work ethics and ambient
working conditions, amongst others.
Employees are the most valuable assets for TSA INFO SERVICES. The organization firmly
believes that employees can contribute to quality only when they are comfortable with their job
and the environment, in which they are employed. Employees are groomed to maintain a clean
atmosphere in their area and are provided with tools, equipment and training required for their
jobs. Safety instructions are established, where applicable to avoid any hazards. Suggestion
scheme is adopted in the organization through which any employee can propose valuable
suggestions. In addition to that, Employee Feedback Survey is also conducted by the
management periodically to determine the needs for any improvement actions.
MANAGEMENT
• Determine necessary
competence.
• Provide training or take other
Human resources appropriate actions.
• Evaluate effectiveness of action
taken.
• Define job descriptions.
▪ TSA INFO SERVICES currently does not have any inspection, measuring and monitoring
equipment, instruments or devices in use which may have an impact on the quality of
products or on the conformity of products to determined requirements and which require
calibration control for performing the services or activities.
▪ Necessary procedures detailing the calibration control process will be put in place as and
when TSA INFO SERVICES happens to require such monitoring and measuring devices /
instruments for use needing calibration control program.
Document References:
▪ The organization determines the knowledge necessary for the operation of its processes
and achieve conformity of products and services this knowledge shall be maintained and
be made available to the extent necessary.
▪ When addressing changing needs and trends, the organization would consider its current
knowledge and determine how to acquire or access any necessary additional knowledge
and required updates.
Document References:
7.2 Competence
Detailed Job descriptions are defined by the management detailing designations, job
responsibilities, general education and experience required for all job positions based on
competence required for each job category. Job Descriptions are available with the respective
Department Heads and copies thereof are also maintained in the employee personnel files. Job
Descriptions form the basis of recruitment, transfers, promotions and training of personnel.
All company personnel are hired on the basis of the necessary competence of doing work under
its control that not affects the performance and effectiveness of the quality management system
and ensure that these persons are competent on the basis of appropriate education, training, or
experience.
Management conducts periodic reviews of employee performance. Appropriate records of
education, training, skills and experience will be maintained.
Necessary competence is determined for personnel who are assigned to perform work affecting
product or service quality, by referring to their education, training, skills and experience profile.
The Department Heads periodically evaluate the performance of their staff and identify individual
training needs. The CEO evaluate the performance of the Department Heads and identify their
training needs
The Internal auditing process evaluates the effectiveness of training and its effect on product and
service quality; in addition, the review of training effectiveness is a permanent feature of
Management Review.
Document References:
▪ Competency Matrix
7.3 Awareness
Document References:
7.4 Communication
The QMS is communicated and made accessible to all levels of employees in the organization.
Each Department Head assumes the responsibility for proper communication to his / her
subordinates. All technical / commercial information for processes are communicated through
appropriate documents to relevant functions. Telecom and intercom services, email, internet and
mobile phones are provided to various personnel for fast and easy passage of information. In
addition to that special information when required are communicated through memos, circulars,
emails or meetings organized within the offices. Effectiveness of Quality Management System is
communicated through Quarterly Trend Charts & Quality Performance Reports, which are
discussed at management review meetings.
Additional communication mechanisms for example; E-Mail, Fax, Information sharing database
programs, and Memos will be employed as appropriate.
7.5.1 General
TSA INFO SERVICES quality management system is defined in four levels of documentation as
described below to implement its quality policy and to achieve organization’s quality objectives:
1) Quality Manual that includes the scope of the quality management system, details and
justifications for exclusions, documented statements of a quality policy and quality
objectives, references to the documented quality system operating procedures established
for the quality management system and a description of the interaction between various
processes of the quality management system.
2) Documented quality management system operating procedures required by the ISO
9001:2015 standard and by the organization,
3) Work instructions & Job Descriptions needed by the organization to ensure the effective
planning, operation and control of its processes, and
4) Quality records (forms, reports etc.) required by the ISO 9001:2015 standards.
The documentation shall be in any form or type of medium i.e. hard or soft (electronic) versions
as determined by DC.
All quality system documents such as the Quality Management System Manual, Quality
Management System Operating Procedures, Work Instructions and Job Descriptions are
distinguished by a unique identification number, document title, date of issue / re-issue, revision
status and positions and / or signatures of persons who have prepared, reviewed and approved
the documents. All forms carry the title, document number, revision status and date of issue / re-
issue. Controlled copies of the quality system documents placed on computer system network
are electronically controlled by DC and hence do not require any signatures.
Preparation, review and approval of quality system documents are carried out as per the
authority defined in Operating Procedure QP–001: Control of Document. A master log of quality
system documents is maintained which is the primary reference record for document control.
Quality system documents are issued to the locations / points of use and / or to the staff of this
manual. Only “CONTROLLED” copies of quality management system documentation are issued
within the organization. A “CONTROLLED” version of all quality management system
documentation is also made available to all staff electronically through computer system network
which can be accessed by the staff through controlled passwords. Changes to or the re-
production or distribution of the quality system documentation including the electronic version can
only be made by the Management Representative/ Document controller.
“Uncontrolled” copies of Quality Manual and other quality management system documentation
may be issued to customers, external auditing agencies, assessment bodies or any other third
parties at the discretion of DC. “Uncontrolled” copies of documents are current only at the time
of issue and the organization has no obligation to issue revisions to update those documents.
There are no products/ Services related National and / or International Standards applicable to
the organization at present. Products/ Services related documents are given to the customers in
original with the products supplied, as received from the Principals / Vendors. Customer
specifications / purchase orders / contracts are handled as defined in relevant procedures.
The quality management system documents are subject to revision, as and when required, to
reflect the current practices and also to effect continual improvements to the quality management
system. Changes to quality management system documents can be requested by any user by
completing Form No. QF-DC-005, obtaining the approval of his/her Department Head and any
other Department Head(s) involved and forwarding the form to the DC through his / her Dept.
Head.
The DC reviews all such change requirements, ensures its adequacy and verifies that the
proposed changes meet the requirements of ISO 9001:2015 standard. Document change,
review, approval and distribution follow the same control procedures which apply to the issue of
original documents. All revised documents are distributed to those persons, locations / points of
use or departments who had received or had access to the “CONTROLLED” copies / versions of
the original documents. Copies of obsolete or non-applicable documents and / or sections are
withdrawn and destroyed and also electronically deleted by DC to prevent their inadvertent use.
Obsolete Master is cancelled with “OBSOLETE” stamp and is retained by DC for records.
Computer held data is acceptable as a means of storage, communication and approval. Such
data and its communication is controlled and secured through controlled passwords and hence
such data and communications do not require signatures.
Records are stored and maintained in an easily retrievable manner. Identification, collection, filing
and maintenance of records are carried out as per documented procedures. Records are
maintained in the concerned departments for a prescribed period of time after which they are
destroyed. The retention periods of records are defined in the respective procedures based upon
their importance. Quality records such as test reports are issued to customers, when required.
The detailed list of quality records generated the department or staff responsible for maintaining
them and their retention periods are summarized at the end of each Operating Procedure.
Reference Procedures
Following are the detailed procedures which control the activities described in this section
QMS Manual
Level 1
Planning
Quality policy, Quality objectives
Allocation of resources
Quality management system
Product/Services Realization
Key
Normal Process
8. Operation
8.1.1 This section describes the management of various processes determined, planned and
developed by TSA INFO SERVICES for product realization. The planning of product realization is
consistent with the requirements of the other processes of the quality management system and is
designed to ensure that the products and services meet agreed customer requirements.
8.1.2 All processes involved in the business of the organization are determined by the management
considering the quality objectives and requirements for the product and the responsibilities for
their execution are assigned to various departments in the organization.
8.1.3 Processes are defined and documented in the form of procedures, instructions and / or flow
charts showing their sequence and interaction with each other and are communicated to all
concerned. The management ensures the availability of adequate resources and information
specific to the product for the operations of all departments in the organization.
8.1.4 Necessary verification, validation, monitoring and where applicable measurement, inspection and
test activities specific to the product are carried out by the designated staff to meet the criteria for
product acceptance. Corrective actions are initiated, as required. All information is reviewed and /
or verified by concerned staff for conformance with the requirements. Records providing evidence
that the realization processes and resultant products meet requirements are generated and
maintained in respective departments.
Document References:
8.2.1.1 Clear communication is maintained with the customer in relation to product information. All
inquiries, contracts or orders including their amendments in any form are appropriately reviewed
by all concerned. If any points are unclear or any clarification is required, it is taken up with the
customer. Material purchases and service activities are planned only after ensuring that the
conditions of sale are mutually understood and agreed upon with the customer.
8.2.1.2 Customer complaints are logged into the system and immediate corrective actions are initiated,
as required. Actions are communicated to customers and if the complaint is due to unawareness
/ negligence of any staff, necessary training is provided as a Corrective action to avoid similar
repetition in future.
8.2.1.3 A system is established to collect the customer feedback as stated in Section 8.2.1 of this manual
with an objective to measure customer satisfaction to introduce improvement actions to service
customers better.
8.2.2.1 Upon receiving inquiries from the customers, the scope of work is reviewed by the relevant staff
to check whether the organization is capable to deliver the product / service requirements
specified by the customer including the requirements for delivery and post-delivery activities.
8.2.2.2 In this regard, all relevant requirements are adequately considered by the management including
availability of resources and facilities and the requirements not stated by the customer but
necessary for specified or intended use, where known.
8.2.2.3 Applicable statutory and regulatory requirements affecting the products and services are also
taken into consideration while reviewing the customer inquiries, along with any additional
requirements which are determined by the organization.
8.2.3.1 Customer requirements related to the product are reviewed prior to making a commitment from
the organization to supply a product to the customer before submission of tenders or proposals,
acceptance of contracts or orders and acceptance of changes to contracts or orders.
8.2.3.2 Product requirements and specifications are properly defined. Contract or order requirements
differing from those previously expressed or agreed upon are resolved and the organization’s
capability to meet the defined requirements is assessed.
8.2.3.3 Records showing results of the review and follow up actions arising from the review are
maintained by the concerned staff.
8.2.3.4 Where the customer has not provided a documented statement of requirement, the customer
requirements are confirmed by the organization before acceptance. Any changes to the product
requirements are reflected in all the relevant documents and the concerned personnel are made
aware of the changed requirements. In situations involving internet / web based sales, where a
formal review may not be practical for each order, reference is made to relevant product
information, catalogues, brochures, advertising material etc. to satisfy the review requirement.
8.2.3.5 Proposals and quotations are prepared on the basis of this review. Upon reviewing the inquiry, if
it is felt that the customer’s requirements cannot be met, it is apologised.
TSA INFO SERVICES ensure that relevant documented information is amended, and that
relevant persons are made aware of the changed requirements, when the requirements for
products and services are changed.
Document References:
8.3.1 General
TSA INFO SERVICES established, implemented and maintained a design and development
process that is appropriate to ensure the subsequent provision of products and services.
▪ Design planning is carried out according to design plan, which is illustrated in relevant
procedures. Effective flow of information and documents at interfaces between various
involved parties is achieved through design drawings and instructions.
▪ The Design functions concerned review customer requirements for adequacy, and the
customer is requested to clear out any TSA INFO SERVICES equities or inquiries.
▪ Design drawings and instructions are reviewed and verified against input requirements,
applicable standards Statutory & Regulatory requirements, safety and functional
requirements. Subsequent review and validation are performed.
▪ All design drawings and documents are identified, approved, updated and controlled.
▪ The procedure requires that design validation to be carried out internally through customer
feedback, where practicable. Records of review and checks are maintained.
▪ Records of design changes are maintained to ensure that design changes can be traced
and that the current design documents reflect all design changes and verification /
validation.
▪ The design process will be planned and detailed in the attached “Design Plan”. Where
applicable, other design particulars such as additional resources and special design
requirements and interfaces shall be recorded by the Design Engineer. Such records shall
be attached to the Design Plan.
Document References:
TSA INFO SERVICES determined the requirements essential for the specific types of products
and services to be designed and developed. The TSA INFO SERVICES has considered:
▪ Functional description documents/ drawings and the following as applicable are supplied
by the customer along with the enquiry defining any design requirements, which will
constitute inputs for design:
▪ Customer Specifications
▪ Diagrams/Drawings/Sketches
▪ Site visit reports
▪ Previous Proven Design
▪ Additionally, the following shall also constitute as input for design:
▪ Local authority
▪ BS, EN, IEC and other International Standards
▪ Product Standards (from suppliers including catalogues)
▪ Aspects and Hazards
▪ QHSE Objectives and Programme
▪ Initial documents/ drawings are verified and reviewed for adequacy by Dept. Manager as a
part of Contract Review and subsequently by the Designer of the specific discipline. Any
ambiguities and conflicting requirements are recorded and agreed with the customer.
Conflicting design and development inputs has been resolved. TSA INFO SERVICES has
retained documented information on design and development inputs.
Document References:
TSA INFO SERVICES controls the design and development process to ensure that:
▪ The results to be achieved are defined.
▪ Reviews are conducted to evaluate the ability of the results of design and development to
meet requirements.
▪ Verification activities are conducted to ensure that the design and development outputs
meet the input requirements.
▪ Validation activities are conducted to ensure that the resulting products and services meet
the requirements for the specified application or intended use
▪ Any necessary actions are taken on problems determined during the reviews, or
verification and validation activities;
▪ Documented information of these activities is retained.
Document References:
Document References:
TSA INFO SERVICES ensures that design and development changes shall identify, review and
control changes made during, or subsequent to, the design and development of products and
services, to the extent necessary to ensure that there is no adverse impact on conformity to
requirements.
Document References:
8.4.1 General
8.4.1.1 The organization has established documented procedures for purchasing, selection, approval
and monitoring of vendors’ performance. Products and services are generally purchased only
from vendors who clearly demonstrate their capability to meet the requirements and
specifications of the products and TSA INFO SERVICES purchase orders to ensure that
purchased products conform to specified purchase requirements.
8.4.1.2 All purchases are made from approved vendors only. Evaluation and selection of vendors is
based on their ability to supply products in accordance with TSA INFO SERVICES requirements.
Lists of Approved Principals and Vendors for various products and services have been
established, which are available with all staff concerned. If for any reason, an order has to be
placed with a Vendor who is not on the approved vendors’ list, such a requirement is properly
assessed and approved by the concerned managers prior to issuance of a Purchase Order.
8.4.1.3 Products and Services are generally purchased against confirmed customer orders. A Purchase
Requisition is used when the purchases are required to be made for any purposes other than
against confirmed customer orders and spare parts requirements. Spare parts are purchased as
per the requirements of the Customer Services Department.
8.4.1.4 Vendors’ evaluation and re-evaluation is carried out as per documented procedures, which define
criteria for selection, evaluation and re-evaluation, according to which vendors failing to maintain
the quality of their products and / or services are disqualified and removed from the company’s
list of approved vendors. Records of the results of evaluations and any necessary actions arising
from such evaluations are maintained to demonstrate the performance of all vendors.
Document References:
▪ Purchasing Supplier Control Supplier Approval - QP 07
▪ List of Suppliers
▪ Supplier Evaluation / Reevaluation
8.4.2.1 TSA INFO SERVICES has implemented documented procedures necessary for verification of
purchased products, according to which all purchased products are verified at the point of receipt
to ensure that they conform to the specified purchase requirements. If any purchased product is
found to be non-conforming, it is isolated and prevented from use and records of such non-
conformances / deviations are used for monitoring suppliers’ performance.
8.4.2.2 Verification of purchased products before shipment / delivery either at TSA INFO SERVICES ‘s
premises by the customers or at vendors’ premises by TSA INFO SERVICES is generally not
applicable to our scope of operations.
8.4.3.1 All purchasing documents (purchase orders / contracts) clearly describe the specifications of the
products to be purchased, packing conditions, where applicable, required delivery time, and other
requirements for approval / acceptance of product, in addition to payment conditions and other
quality requirements (such as provision of test reports etc.), where necessary. Purchasing
documents (Purchase Requisitions, purchase orders / contracts) are subject to review and
approval by authorized personnel as per the company’s documented Purchasing Procedures.
8.4.3.2 Purchasing information also includes requirements for qualification of personnel, where
appropriate and other quality management system requirements.
8.4.3.3 Adequacy of specified purchase requirements is reviewed and ensured before the purchasing
documents are communicated to the vendors.
Document References:
8.5.1.1 TSA INFO SERVICES has implemented documented procedures to manage the process of
products and service provision according to which all activities are planned and carried out under
controlled conditions by:
▪ Making the information available describing the characteristics of the product;
▪ Providing work instructions, wherever necessary;
▪ Specifying the use of suitable equipment, where applicable;
▪ Implementing suitable monitoring and measurement activities; and
▪ Implementing suitable methods for release, delivery and installation of products and / or
post-delivery support services.
8.5.1.2 Installation and after Sales support of products and services sold are carried out according to
these procedures. All confirmed orders for supply are reviewed by appropriate personnel for
availability of materials in the store. Products and Services are supplied as per customers’
specified requirements and the records of such deliveries are maintained. All products received
for maintenance undergo an inspection and operations are planned and verified to ensure that
they are properly controlled and are being carried out in the specified manner and sequence.
8.5.1.3 All personnel performing services activities are suitably skilled, qualified and trained. New
employees are suitably oriented and / or trained to ensure their service capability. Effectiveness
of established processes and procedures is examined through internal audits and analysis of
trends in the performance and effectiveness of the system for further improvements.
8.5.1.4 All repairs or maintenance services are subject to suitable inspection and verification process by
the respective personnel, after which only they are delivered to customers. Stores have the
responsibility to ensure that the products are properly stored and transported / delivered to
customers.
8.5.2.1 TSA INFO SERVICES has implemented documented procedure to maintain the identification and
traceability of products and services being provided which allow products to be identified by
suitable means throughout all stages of product realization.
8.5.2.2 All installation / service related reports and documents are stored in such a manner that the
identification and traceability requirements are met. All jobs and their status can be identified
through records which carry clear traceability to various processing stages, conditions, inspection
status and personnel who performed the job to allow appropriate monitoring and measurement.
8.5.2.3 Traceability to all products is maintained by storing them in designated storage locations and by
using specific item codes, serial numbers or suitable identifications tags, as appropriate.
8.5.2.4 The required traceability is available for all products supplied through delivery documents, item
codes, serial numbers and / or suitable identification tags, as appropriate.
8.5.2.5 Traceability to products brought in for repairs / testing is maintained through the use of suitable
identification tags, item codes or serial numbers.
8.5.2.6 Proper identification is maintained to separate customers’ property from company’s own property
by storing them in designated storage areas and through the use of item codes, serial numbers
or suitable identification tags, as appropriate.
8.5.3.1 TSA INFO SERVICES has implemented documented Procedures to carry out receiving
inspection and handling of customers’ property. All customers’ products are appropriately
identified by storing them in designated storage areas and through the use of item codes, serial
numbers or suitable identification tags, as appropriate, to avoid mix-up.
8.5.3.2 According to TSA INFO SERVICES ‘s policy and procedures, all staff dealing with customers’
property are responsible to exercise due care at all stages to prevent damage or loss to
customers’ property while it is under the organization’s control or is being used by the
organization (including properties at customer’s premises). All customer property provided to TSA
INFO SERVICES for use or incorporation into TSA INFO SERVICES provided products is being
suitably identified, verified, protected and safeguarded.
8.5.3.3 If any customer property is lost, damaged, found to be defective or unsuitable for use and not
specified by the customer as such but observed by TSA INFO SERVICES personnel during or
after receipt is reported to the customer and records to this effect are maintained. Damage or
loss observed during the testing or repair process is also brought to the notice of the customer.
8.5.3.4 Only after getting customer’s comments or TSA INFO SERVICES management’s acceptance,
further processes are undertaken.
8.5.4 Preservation
8.5.4.1 There are some specific preservation processes currently applicable to TSA INFO SERVICES
business operations since the company deals in computer hardware and software and clients
information, which do require specific preservation in database or cloud security.
8.5.4.2 However, all products/ services are subjected to suitable identification, handling, packaging,
storage and protection throughout the internal processing and delivery to the intended destination
to ensure delivery in good condition to the customers and to preserve the conformity of product to
stated requirements. Same preservation also applies to the constituent parts or components of
the products.
Installation and after Sales support of products and services sold are carried out according to
these procedures. All confirmed orders for supply are reviewed by appropriate personnel for
availability of materials in the store. Products/ Services are supplied as per customers’ specified
requirements and the records of such deliveries are maintained. All products received for
maintenance undergo an inspection and operations are planned and verified to ensure that they
are properly controlled and are being carried out in the specified manner and sequence.
The management shall give the sufficient data through verification and validation activities. If
Design and development changes are identified then the necessary changes are reviewed,
verified and validated and approved before implementation. The review of design and
development changes shall include evaluation of the effect of the changes on constituent parts
and product already delivered. Records of the results of the review of changes and any
necessary actions shall be maintained.
Inspections and verifications are carried out at appropriate stages of the product realization
process in accordance with the planned arrangements and documented procedures to verify that
product requirements have been met. Results of inspection are reviewed to decide the
acceptance of such products. All non-conformances are reported and rectified and re-inspection
is performed before further processing.
Appropriate records are maintained to provide evidence of conformity with the specified
acceptance criteria. Records clearly indicate the persons who have verified, accepted and
authorized the products for release.
Product release and service delivery is carried out only after all specified activities and planned
arrangements have been satisfactorily completed and related documentation is available and
authorized, unless otherwise approved by a relevant authority within TSA INFO SERVICES
management and where applicable, by the customer.
8.7.1 A documented procedure is established by TSA INFO SERVICES to define the controls and
related responsibilities and authorities for dealing with non-conforming product at any stage of
product realization.
8.7.2 All processes are closely monitored in each department and appropriate records are maintained,
reviewed and verified. Any product which does not conform to specify product requirements, is
identified and controlled to prevent its unintended use or delivery. If any non-conformances are
observed, immediate corrective actions are taken to prevent a non-conforming product / service
reaching the next stage of the process or to the customer. Data of such non-conformances are
reviewed to prevent similar problems in future.
8.7.3 In case of a non-conformance observed in purchased products, the non-conforming items are
identified and separated and communicated to the supplier for necessary corrective action. Only
accepted materials are processed further for delivery.
8.7.4 All non-conforming products shall be suitably dealt with in one or more of the following ways: (a)
by taking corrective action to eliminate the detected non-conformity, (b) by authorizing its use,
release or acceptance under appropriate concession from a relevant TSA INFO SERVICES
management authority and where applicable, from the customer, (c) by re-assigning it for
alternative valid use or application which does not affect quality, or (d) by rejecting it as
unsuitable to prevent its original intended use or application. If for any unlikely reasons, a non-
conforming product is detected after delivery or use has started, appropriate action shall be taken
to deal with or correct the effects, or potential effects of the non-conformity as part of the post-
sales / warranty support services. Records of the nature of non-conformities and any subsequent
actions taken, including concessions obtained, are maintained.
8.7.5 When a non-conforming product is corrected, it is re-verified to ensure conformity to the specified
requirements.
Document References:
9. Performance Evaluation
9.1.1 General
This section describes the system adopted by TSA INFO SERVICES. to plan and implement the
monitoring, measurement, analysis and improvement processes needed to demonstrate
conformity of the products and services, to ensure conformity of the quality management system
and to continually improve the effectiveness of the quality management system including
determination of applicable methods, statistical techniques and the extent of their use.
The types, methods, frequency and responsibility of measurements and the requirements for
records to be maintained are defined in documented procedures. The effectiveness of measures
implemented is periodically reviewed. The results of such reviews form an input to the
management review process.
Document References:
9.1.2.1 As one of the measurements of the performance of the quality management system, TSA INFO
SERVICES has adopted a documented procedure to get the feedback from customers once
every year through a customer satisfaction survey to gather and monitor information relating to
customers’ perception as to whether the organization has met customer requirements
satisfactorily. This information is used to measure customer satisfaction and to initiate required
improvement actions.
9.1.2.2 Records relating to customer calls and complaints are reviewed periodically to identify if there are
any repeated problems of same nature and to ensure effective corrective actions to address
them.
9.1.2.3 Commitment of the employees is ensured in all jobs to achieve the objectives of the organization.
A survey is carried out once every year as per a documented procedure to get employees’
feedback, which is aimed at encouraging employees to provide their suggestions for continual
improvement. Information gathered from such surveys and suggestions is used by the
management to provide a healthy and comfortable work environment to employees.
Document References:
In order to demonstrate the continuing suitability and effectiveness of the quality management
system and to evaluate potential opportunities for continual improvement, all appropriate data
and information relating to customer satisfaction/feedback, customer calls/complaints, corrective
actions, results of internal quality audits, suppliers’ performance, conformity or non-conformity to
product requirements, and characteristics and trends of processes and products including
opportunities for Corrective actions and improvements are collected, statistically analyzed and
reported as per a documented procedure. Techniques such as Trend Analysis, Pareto Analysis,
and Cause and Effect Analysis are applied, where applicable and appropriate, for Statistical
Analysis. Results of the statistical analysis are reviewed during management review meetings
and are used for directing efforts towards continual improvements, formulating corrective actions,
and preventing the re-occurrence of quality related problems.
Document References:
9.2.1 Internal quality audits are carried out by trained internal auditors twice a year to determine
whether the quality management system conforms to the planned arrangements, to the
requirements of ISO 9001:2015 standard and to the quality management system requirements
established by the organization and whether it is being effectively implemented and maintained.
Additional extraordinary audits can also be performed, if found necessary.
9.2.2 An audit programme is planned, taking into consideration the status and importance of each
process and area to be audited as well as the results of previous audits. The audit criteria, scope,
coverage, frequency and methods are defined in a documented procedure. Selection of auditors
and conduct of audits is done in such a way that objectivity and impartiality of the audit process is
ensured. Auditors are not assigned to audit their own work.
9.2.3 The responsibilities and requirements for planning and performing internal audits, for reporting
results and for maintaining records are defined in a documented procedure.
9.2.4 Necessary corrective actions are initiated by the management responsible for the area being
audited, without undue delay to eliminate detected non-conformities and their causes. Follow up
activities are undertaken to implement the identified corrective actions, to verify their
implementation and to report the results of such verification.
Document References:
9.3.1 General
A review meeting is held by the top management once in every six months to review the quality
management system to ensure its continuing suitability, adequacy and effectiveness. The review
also includes assessing opportunities for improvement and the need for changes to the quality
management system, including the quality policy and quality objectives to provide customer
satisfaction.
The output from the management review includes any decisions and actions related to:
▪ Improvement of the effectiveness of the quality management system and its processes to
strengthen the system in all areas.
▪ Improvement of product / services related to customer requirements to enhance customer
satisfaction.
▪ Setting new quality objectives or revising objectives for various functions.
▪ Resource needs and any improvements in skills / resources including human resources,
training and education plans, equipment etc.
9.3.4 The CEO chairs the meeting and DC and other Department Heads attend this meeting along with
other senior staff, as required. Concerned Department Heads are informed about any existing
non-conformances in their respective departments / operations and the consequent corrective
actions that need to be taken. The DC and the concerned Department Heads monitor the
implementation of corrective actions. CEO resolves any difference of opinions between the
participants.
9.3.5 Records of management review meetings are prepared and maintained by DC.
Document References:
10. Improvement
10.1 General
TSA INFO SERVICES aims at continually improving the effectiveness of the quality management
system documented in this quality manual through the use of the quality policy, quality objectives,
audit results, analysis of data, corrective actions and management reviews.
10.2.1 The corrective actions are taken to eliminate the causes of non-conformities observed in
products, services or processes and systems at various stages in order to prevent their
recurrence. Corrective actions shall be appropriate to the effects of the non-conformities
encountered.
10.2.2 TSA INFO SERVICES has established documented procedures to define requirements to identify
and review non-conformities including customer complaints, to determine the causes of non-
conformities, to evaluate the need for actions to ensure that non-conformities do not recur, to
determine and implement corrective actions needed, to record the results of corrective actions
taken and to verify implementation of the corrective actions to review that corrective actions taken
are effective.
10.2.3 Information concerning the non-conforming products and services received from principals/
vendors is promptly communicated to the concerned principal / vendor for necessary corrective
action.
10.2.4 All customer complaints received are given due attention and are handled and resolved as per a
documented procedure. Both immediate and long-term corrective actions are taken to resolve the
customers’ complaints.
10.2.5 Whenever any non-conformity from specified requirements is observed, immediate corrective
action is initiated for rectification. Re-verification is carried out to ensure the implementation and
effectiveness of the corrective actions.
10.2.6 All employees are encouraged to take and recommend appropriate corrective actions to prevent
all types of non-conformities. Records of corrective actions are maintained.
Document References:
▪ Corrective actions - QP-009
It is the goal of all employees to continually improve the effectiveness of the quality management
system through the use of the quality policy, quality objectives, audit results, analysis of data,
corrective actions, management reviews and other improvement opportunities. TSA INFO
SERVICES monitors the implementation of improvement activities and evaluates their
effectiveness.
Document References:
▪ Corrective actions - QP-009
▪ Audit Results
▪ Objectives status
▪ MRM Outputs
▪ Customer Feedback
▪ Customer complaint
▪ Supplier Evaluation / Reevaluation
11. APPENDIXES
Proposal Development 8.2.2 Determining the requirements related to products and services
and Contract Review 8.2.3 Review of requirements related to products and services
Purchasing 7.1.4 Environment for the operation of processes
8.4 Control of externally provided processes, products and services
Stores 8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.6 Release of products and services
8.7 Control of nonconforming outputs
Customer Support 4.3 Determining the scope of the quality management system
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.5.4 Customer Property
8.7 Control of nonconforming outputs
8.5.3 Property belonging to customers or external providers
9.1.2 Customer satisfaction
10.2 Nonconformity and Corrective Action
Information Services 8.2.1 Customer communication
8.5 Production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.6 Release of products and services
8.7 Control of nonconforming outputs
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
10.2 Nonconformity and Corrective Action
Internal Auditing To ensure ongoing continual improvement through the reporting and
timely resolution of existing and potential nonconformities
Proposal Development and To provide competitive and profitable quotations to win bids and to
Contract Review accurately process order information for internal use
Enquiry
Yes
Rejected
Customer : Proposal
Accepted or Rejected
Accepted
Support Manager
will start the
process
Testing
Department will
check for any Bug
Final application/Product
delivered to the client
CEO
Operation
Manager
HR Manager
Payroll
Controller
QUALITY POLICY
As part of its ongoing commitment to excellence TSA INFO SERVICES is committed to supply the highest
quality across all the company’s business areas.
By consistently providing services that meet or exceed customer expectations and international standards,
we will develop customer loyalty and so achieve strong business performance in the field of
All employees are expected to achieve high quality standards. It is company policy to:
❖ Maintain and keep records of a quality management system in accordance with international
standards, regulations and directives
❖ Ensure all staff are fully trained and understand their role providing quality and good customer service
❖ Provide services which fully meet customer requirements
❖ Develop or acquire services which are Cost effective, safe and reliable
❖ Make sure the services and materials from suppliers are of consistent and sufficient in quantity and
quality
❖ Strive for continual improvement in performance, underpinned by the necessary financial resources,
and highlight objectives and progress through internal and external communications.
(Signature)
[CEO]
List of Documents
Sl. Document / Description Revision Status Responsibility Retention Disposal Disposal
No Format No Rev No. Rev Date Period Authority Method
1 TSA/DC/PRO 04 Control of Documents 0 03.01.19 MR /DC 3 years DC Archive
2 TSA/DC/PRO 04 Control of Records 0 03.01.19 MR /DC 3 years DC Archive
3 TSA/DC/PRO 09 Internal Audit 0 03.01.19 MR /DC 3 years DC Archive
4 TSA/DC/PRO 04 Control of Non-Conforming Products 0 03.01.19 MR /DC 3 years DC Archive
5 TSA/DC/PRO 05 Corrective Action Report 0 03.01.19 MR /DC 3 years DC Archive
6 TSA/HR/PRO / 06 Training 0 03.01.19 MR /DC 3 years DC Archive
7 TSA/PUR/PRO 07 Purchasing Supplier Control 0 03.01.19 MR /DC 3 years DC Archive
8 TSA/MRM/PRO 08 Management System Review 0 03.01.19 MR /DC 3 years DC Archive
9 TSA/DC/PRO 09 Audit Plan 0 03.01.19 MR /DC 3 years DC Archive
10 TSA/SAL/PRO -10 Customer Satisfaction 0 03.01.19 MR /DC 3 years DC Archive
List of Formats
Sl. Clause No Document / Description Revision Status Responsibility Retention Disposal Disposal
No Format No Rev Period Authority Method
Rev Date
No.
1 4.1 TSA/QF/01 Context of organization 0 03/01/19 MR 3 years DC Archive
2 4.2 TSA/QF/02 Needs and Expectations of 0 03/01/19 MR 3 years DC Archive
Interested Parties
3 4.4 TSA/QF/03 QMS Process Map 03/01/19 MR 3 years DC Archive
4 5.3 TSA/QF/04 Roles and Responsibilities 0 03/01/19 MR 3 years DC Archive
5 6.1.1 / 6.1.2 TSA/QF/05 BIZ Risk 0 03/01/19 MR 3 years DC Archive
6 6.1.3 TSA/QF/06 Legal register 0 03/01/19 MR 3 years DC Archive
7 6.2 TSA/QF/07 Objective & Targets (O&T) 0 03/01/19 MR 3 years DC Archive
8 7.2 TSA/QF/08 Competence Matrix 0 03/01/19 MR 3 years DC Archive
9 7.2 TSA/QF/09 Annual Training Plan 0 03/01/19 MR 3 years DC Archive
10 7.2 TSA/QF/10 Training Attendance 0 03/01/19 MR 3 years DC Archive
11 7.2 TSA/QF/11 Training effectiveness 0 03/01/19 MR 3 years DC Archive
12 7.4 TSA/QF/12 Communication Register 0 03/01/19 MR 3 years DC Archive
List of Formats
Sl. Clause No Document / Description Revision Status Responsibility Retention Disposal Disposal
No Format No Rev Period Authority Method
Rev Date
No.
13 7.5 TSA/QF/13 Document Change Note 0 03/01/19 MR 3 years DC Archive
14 7.5 TSA/QF/14 List of Documents of 0 03/01/19 MR 3 years DC Archive
external origin
15 8.2 TSA/QF/15 Customer communication 0 03/01/19 MR 3 years DC Archive
17 9.1 TSA/QF/17 Performance monitoring 0 03/01/19 MR 3 years DC Archive
Report
18 9.1 TSA/QF/18 Calibration Plan 0 03/01/19 MR 3 years DC Archive
19 9.2 TSA/QF/19 List of Internal Auditors 0 03/01/19 MR 3 years DC Archive
20 9.2 TSA/QF/20 Internal Audit Plan 0 03/01/19 MR 3 years DC Archive
21 9.2 TSA/QF/21 Internal Audit Schedule 0 03/01/19 MR 3 years DC Archive
22 9.2 TSA/QF/22 Internal Audit check list 0 03/01/19 MR 3 years DC Archive
23 9.2 TSA/QF/23 Non-Conformance report 0 03/01/19 MR 3 years DC Archive
24 9.3 TSA/QF/24 Minutes of management 0 03/01/19 MR 3 years DC Archive
review meeting
List of Formats
Sl. Clause No Document / Description Revision Status Responsibility Retention Disposal Disposal
No Format No Rev Period Authority Method
Rev Date
No.
25 10.2 TSA/QF/25 NC Report 0 03/01/19 MR 3 years DC Archive
26 10.3 TSA/QF/26 Kaizen Report 0 03/01/19 MR 3 years DC Archive
27 8.1 TSA/QF/29 Preventive Maintenance 0 03/01/19 MR 3 years DC Archive
28 8.1 TSA/QF/30 Preventive Maintenance 0 03/01/19 MR 3 years DC Archive
Record
Control of Documents
Amendment History
1. PURPOSE:
The purpose of this procedure is to ensure that all documents within the Quality Management System as per ISO 9001:2015 Standards, are formally
identified and issued, and that the correct issues are used.
2. SCOPE OF APPLICATION:
This procedure applies to all levels of documents pertaining to ISO 9001:2015
3. RESPONSIBILITY:
The Management Representative/ Document Controller shall be responsible for maintenance of documents and issue control.
4. PROCESS:
DC List of Documents
5. Reference Documents:
Control of Records
Amendment History
Rev. No. Date Description of Change Prepared by Approved by
1. PURPOSE:
To define the methodology followed for coding, review, approval, issue, control and changing records, data
2. SCOPE OF APPLICATION:
This procedure applies to all levels of documents pertaining to ISO 9001:2015
3. RESPONSIBILITY:
Management Representative / Document Controller (DC)
4. PROCESS:
5. Reference Documents:
Amendment History
1. PURPOSE:
To document the methodology followed for planning, scheduling, conducting and monitoring of Internal QMS Audits
2. SCOPE OF APPLICATION:
The scope of this procedure covers for all processes / functions identified and documented along with the requirements of ISO 9001:2015
3. RESPONSIBILITY:
Management Representative/ Document controller – QMS
4. PROCESS:
5. Reference Documents:
2 9.2.2 Are Previous Audits NCs & observations closed with CAR?
10.2
3 4.1 Is Org. context identified and documented?
Standard Department Non- Conformity Minor Corrective Action Responsibility Target Effectiveness Status
& Clause Detail / Major Date (Open/
Closed)
ISO 9001 MR/DC RA Register not Minor Root Cause: HOD Production 10 days Accepted: Closed
6.1.2 available for payroll Not updated. RA done
activity Corrective Action: Action plan
to complete within one week
ISO 9001 Maintenance Emergency light is Minor Root Cause: HOD 45 days Accepted: Closed
8.5 not working in Checking not carried out Maintenance Replaced the
Office area Corrective Action: light
Regular inspection will be
done.
ISO 9001 Quality For a specific IT Minor Root Cause: HOD Quality 45 days Accepted: Closed
8.1 hardware, there is New requirement from existing Process flow
no plan and control client. has to be
for storage Corrective Action: followed
Any requirement shall be
planned and executed
appropriately
ISO 9001 HR & Admin Risk related to Minor Root cause: HR & Admin 45 days Accepted: Closed
6.1.2 office area not Risk Analysis not updated in
identified Risk Register
Corrective Action:
As above
Root Cause determined by the client as: Missed due to new processes
Objective Evidence:
Correction:
Auditors Comments
Follow up remark
Month 2018
Actual Target
Description Responsibility
2018 2018 Jan Feb Mar Apr May Jun Jul Aug Sep. Oct Nov Dec Status
Process quality
0.098% 0.1% Quality Head 0 0.04 0 0.03 0 0 0 0.02 0 0 0.008 0 0
failure
System downtime
Cases more than 3 0 0 IT 0 0 0 0 0 0 0 0 0 0 0 0 0
hrs. limit
Warehouse Training Warehouse
36 48 8 0 0 8 0 4 0 0 8 0 0 8 36
Man-hours Manager
Internal Audit NC
DC / Quality
implementation 100% 100% 0 0 0 0 0 0 0 closed 0 0 0 closed 100%
Head
closures on time
Customer complaints 2 % 95% Quality Head 0 0 0 0 1 0 1 0 0 0 0 0 2
Prepared by: DC
1. Summary
1.1. The company has established, implemented and maintained this procedure for managing risks and opportunities throughout TSA Info Services.
1.2. Responsibility and authority for this procedure are spread across various functions as defined within this procedure.
1.3. Note: this procedure has adopted definitions for key terms developed specifically by TSA Info Services and determined appropriate for its use
within the unique requirements of its management system. It does not adopt current ISO definitions; which TSA Info Services has determined are
not sufficient for its use.
1.4. Note: the QMS documentation occasionally uses the term “opportunity for improvement” when discussing internal audit findings or management
review actions; that term does not have the same context as the term “opportunity” used herein.
3. Definitions
3.1. Risk: A negative effect of uncertainty.
3.2. Opportunity: A positive effective of uncertainty.
3.3. Uncertainty: A deficiency of information related to understanding or knowledge of an event, its consequence, or likelihood. (Not to be confused
with measurement uncertainty.)
3.4. Risk Assessment: a systematic investigation and analysis of potential risks, combined with the assignment of severities of probabilities and
consequences. These are used to rate risks in order to prioritize the mitigation of high risks.
3.5. Risk Mitigation: a plan developed with the intent of addressing all known or possible risks and preventing their occurrence.
3.6. FMEA (Failure Mode Effects Analysis): a specific risk treatment method which ranks risks by probability and consequence.
4. Procedure: General
4.1. TSA Info considers and manages risks and opportunities differently.
4.2. Risks are managed with a focus on decreasing their likelihood, and minimizing their impact if they should occur.
4.3. Opportunities are managed to increase their likelihood, and to maximize their benefits if they should occur.
4.4. Where risks and opportunities overlap, the best appropriate method for managing them shall be ascertained, given the situation at hand. Elements
of such “blended” uncertainties may require methods which both address the negative risk and positive opportunity.
5.8.4. Assigning a consequence rating if the risk were to be encountered; this consequence is comprised of five elements: eventual loss of
contract; negative impact on existing customers; inability to meet contract terms; any violation of statutory regulations or law; impact on
TSA Info’s reputation; and estimated cost of correction. Again, each element is given a score from 1 (lowest risk) to 5 (highest risk). The
final consequence rating is the average of the elements.
5.8.5. Calculating a final Risk Factor based on the equation:
PROBABILITY RATING x CONSEQUENCE RATING = RISK FACTOR
5.8.6. For risks with a final Risk Factor rating equal to or greater than the threshold set in the Risk Register, management will decide whether to
reject the subject due to the risk, or accept the risks after the development of a risk mitigation plan. The mitigation plan must be
documented, either in the Risk Register or in another document which must be referenced on the form.
5.8.7. Risks with a factor less than the risk threshold may be accepted without a mitigation plan, unless otherwise directed by management.
5.8.8. The Risk Register also allows for setting a “warning” threshold range, where risks that have a Risk Factor within that range are flagged as
suggesting the need for a mitigation plan, but such a plan is not mandatory.
5.8.9. The final column allows for entry of an estimated risk factor after mitigation, which is an estimate on what the risk should be reduced to if
the risk treatment is successful.
5.9. If a risk includes a potential positive aspect, management may elect to conduct an opportunity pursuit assessment on the positive aspect, as
defined below.
6.5.4. Assigning a benefit rating to assess potential benefits if the opportunity is won. This is comprised of six elements: potential for new
business; potential expansion of current business; potential improvements in the organization’s ability to satisfy regulatory or statutory
requirements; potential improvements to the quality management system; potential enhancements of TSA Info’s reputation; and estimated
cost of implementation. Again, each element is given a score from 1 (lowest benefit) to 5 (highest benefit). The final benefit rating is the
average of the elements.
6.5.5. Calculating a final Opportunity Factor based on the equation:
PROBABILITY RATING x BENEFIT RATING = OPPORTUNITY FACTOR
6.5.6. For opportunities with a final Opportunity Factor rating equal to or greater than the threshold set in the Opportunity Register, management
will decide whether to pursue the opportunity through an “opportunity pursuit plan” or to abandon the opportunity altogether. The
opportunity pursuit plan must be documented, either in the Opportunity Register or in another document which must be referenced on the
form.
6.5.7. Opportunities with a factor less than the opportunity target rating may be abandoned outright, unless otherwise directed by management.
6.5.8. The final column allows for entry of success result, once the opportunity has been closed; this includes entries for abandoning the
opportunity, failing to win the opportunity, and three grades of success.
6.6. Analysis of any opportunity will generally result in one of the following possible determinations:
▪ Pursue the opportunity
▪ Explore the opportunity in greater detail before proceeding
▪ Accept the opportunity, but under limited and controlled conditions
▪ Decline the opportunity, typically based on a high expected cost or low anticipated benefit
If an opportunity includes a negative aspect, management may elect to conduct a risk assessment on the negative aspect, as defined above.
Risk Score:
Very High 5 10 15 20 25 Unacceptable risk. Stop project
High 4 8 12 16 20 High risk. Immediate action required
Severity Medium 3 6 9 12 15 Medium risk. Identify actions to minimize
Low 2 4 6 8 10 Minimal risk. Monitor
Very Low 1 2 3 4 5
Very Low Low Medium High Very High
Likelihood
Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
strategy vs
of planned
Open
Open
available market data take corrective action
Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood
(State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
2 5 Medium Risk 1. Prepare cash flow chart Risk Stop the activities. Analyze
2. Find finance for each activity. the situation with experts
3. Check the history of and do corrective action.
receivables and find finance for
Unplanned growth
Top Management
Management
payables.
4. Analyze the expenses
Open
Open
overheads, profit every month
and predict the future situation.
5. If the predicted result shows
negative growth, record non-
conformance and take corrective
action.
Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood
(State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
Open
Open
3. Estimator should get proper
quotations from competent
subcontractors on the new
project.
4. Estimator should put a safety
margin in the quotation.
5. Conditions of the quotation
should be clear to client and
contractor.
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Revision No. 00
Business Risk Analysis
Revision date 03.01.2020
Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood (State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
3 5 High Risk 1. Communicate the risk with Risk Reduce the profit
management for market competition margin, try to stay in
and try to make optimum pricing as per the market until good
market situation. opportunity
2. Propose to client for alternate method
with less pricing.
Estimation manager
Market competition
Open
Open
priority.
4. Negotiate with subcontractors and
vendors for discounts.
5. Push the project team to complete
the project faster to reduce cost on
rented equipment/ Manpower/interest.
6. Appoint cost controller to monitor the
cost and reduce it by implementing new
cost reduction procedure.
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Business Risk Analysis
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Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood (State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
Open
Open
HR
Open
Open
HR
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Business Risk Analysis
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Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood (State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
4 5 Very High Risk 1. Prepare micro level program on with Risk Increase man power
previous experience in any one of the and project
Project delivery time exceeded the
team.
Payroll
Open
Open
3. All inspection request, Request for
information, requests for design change
etc should attend immediately.
4. Try to pass the bills of subcontractors
immediately.
5. Set up milestones and monitor the
progress regularly.
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Business Risk Analysis
Revision date 03.01.2020
Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood (State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
4 4 High Risk 1. Prepare Man power histogram at the Risk Introduce new
Customer requirement
Project Manager
Open
Open
this time, however we understand that
a review of our current procedure will
be required
Open
Open
compliance of subcontractor/vendor
schedule and keep on follow up.
3. Concerned persons should visit
subcontractor / vendor facility regarding
inspection progress.
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Business Risk Analysis
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Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood (State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
Risk effectively
2. Update all legal requirements.
Legal Manager
requirements
Open
Open
Legal
departments. receivables
Open
Open
2. Implement an effective system to get
notified.
3. Implement ERP or similar software
to interconnect all departments.
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Business Risk Analysis
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Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood (State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
4 5 Very High 1. Inform the project team regarding Risk Team support
Design and Development
Open
Open
2. Contract department should send
non-conformance to client contracts.
3. Delay in delivery of the process
Open
Open
time
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Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood (State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
3 4 High Risk 1. Conduct a meeting with vendors to Non availability Produce Letter of
available with vendors
Purchase Manager
local market
Open
Open
2 4 Medium Risk 1. Produce an alternative solution to No other ry to contact the
High price due to market
2. Negotiate with vendor for good price. alternative for reduced price.
available
monopoly
Purchase
Open
Open
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Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood (State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
2 5 High Risk 1. Company should appoint a third party to Risk Conduct regular
Ineffective quality
Quality Manager
Open
Open
six months on all departments with educate everybody
competent auditor. on importance of
3. Monitor quality system with customer quality.
feedback.
3 5 High Risk 1. Design / contract department should give Risk Reject the
Materials received are not complying
material specification.
Quality
Open
Open
3. If mill certificate / data sheet is not
available contractor should not receive the
delivery.
4. Mill certificate and Delivery orders has to
give origin tracking option.
5. Alternative materials should produce
compliance statement.
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Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood (State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
3 5 High Risk 1. List of equipment and tools should be Lack of Stop the inspection
quality inspection
Quality Manager
made with its calibration date and expiry. regular and calibrate the
Non calibrated
equipments
Open
Open
report nonconformance immediately. and immediately
inspection
dispatch.
Open
Open
3. Proper packing material like Hard disk in
anti-static box
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Business Risk Analysis
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Risk Identification Risk Analysis Risk Monitoring and Control Current Status /
Progress
Mitigation Plan Response Contingency Plan
Impact (1-5)
Risk Owner
Description
completion
Risk Score
Likelihood (State corrective action taken) Category
Category
M=11-15
H=16-25
L=1-10
Closed
Open /
Target
(L x I)
(1-5)
date
Risk
(Risk /
Opportunity)
supervisor should
products
Open
Open
be informed about
the incident.
Open
Open
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TSA Info Services
Revision No.
Design and Development Process Analysis
Revision date
Infrastructure and Hardware Risk involved in the Process Competency Requirement for
Material Resource ▪ No proper planning of project Process Owner
▪ Hardware Resource ▪ No proper review of progress of project ▪ Competency Requirement
▪ Infrastructure and Work Environment ▪ No prompt actions on issues ▪ Educational Qualification
▪ Utility Services ▪ No proper communication to customer ▪ Professional Experience
▪ Contingency Plan ▪ Delay in completion of activities ▪ Generic Skills, Soft Skills, and Job Specific Technical
▪ Software Resource ▪ Mistakes due to competency problem Skills
▪ Computer, Printer / Scanner ▪ Frequent modification and changes in design ▪ Responsibilities & Authorities
▪ Internet Facility ▪ No proper validation of design ▪ Reporting Structure
▪ Customer dissatisfaction ▪ Employee Training and Employee Motivation
Inputs for the Process Process Activity Output of the Process
▪ Product design ▪ Project Design Project Planning
▪ APQP and PPAP requirements ▪ Process Flow Chart, Process FMEA, Control Plan
▪ Productivity, Quality, and Cost Targets ▪ Raw Material Test Report
▪ Project Time Frame Design and Development ▪ Product Inspection Report
▪ TGW / TGR Data ▪ PPAP document and customer approval
▪ Customer Specific Requirements ▪ SPC study report and Part layout inspection report
▪ QMS requirements ▪ Gauge calibration and MSA report
▪ Legal requirements ▪ Process Change Note
▪ Previous MRM review ▪ Management Reviews
▪ Internal Audit results ▪ Customer satisfaction & Continual improvement
Process Document & Record Requirements Supporting & Interfacing Processes Process Efficiency & Effectiveness Objectives
▪ Part Drawing & Specifications ▪ Top Management ▪ Process Design Lead Time
▪ DFMEA ▪ Marketing ▪ Incidents of Process Design Modification
▪ Management Review Minutes ▪ Engineering & Production ▪ PPAP Approval
▪ Internal Audit Results ▪ QA ▪ Process Capability
▪ Purchase & Logistics ▪ Internal Audit Result
▪ Maintenance
▪ HR
▪ MR
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