Ref No.
: I/RF/MGR/AMND/001
Rev No.: 06
●
● AMENDMENT SHEET
● Eff Date: 02-09-2019
Document Name:
Rev.
Sr. No. Effective Date Document Reference No. Details of change
No.
1 15-01-2021 I/WI/MGR/RM/001 00
Drafted by: AMR Page 1 of 4 Checked by: MR Approved by: MR
Ref No.: I/WI/MGR/RM/001
WORK INSTRUCTION FOR
Rev No.: 00
RISK MANAGEMENT
Eff. Date: 15/01/2021
PURPOSE:
q To identify external and internal issues of the organization; to capture interested parties, their needs
and expectations; to carry out risk and opportunity for identified issues and interested parties
requirements.
SCOPE:
q Applicable to all functions
RESPONSILBILITY:
q Management Representative
PROCEDURE:
Understanding the context - Issues
● Identify external issues arising for from external parties and update the issue list.
● Identify internal issues within the organization which affects the strategic direction (Vision / Mission) and
update the issue list.
● Issues can include positive and negative factors or conditions. Positive factors are Organization’s
goodwill, appreciation from customer, Customer Satisfaction. Negative factors are Customer
dissatisfaction, Customer complaint, Customer return, In-house rejection. Conditions are market
demand fluctuation, economic condition.
● Understanding the external context is facilitated by considering issues arising from legal, technological,
competitive, market, cultural, social and economic environments, whether international, national,
regional or local. (e.g. legal compliance, adoption of upgraded technology, cost competitive, condition of
Market, impact of product on society, impact of product & process on environment.)
● Understanding the internal context is facilitated by considering issues from values, culture, knowledge
and performance of the SEL. (e.g. activities, products and services, organizational structure, roles and
accountabilities, strategic direction, culture and capabilities (i.e. people, knowledge, processes, systems,
time, capital), dignity of the entire employee, competent manpower, employee satisfaction).
● Each department HOD interacts with the MR and determines issues related to external as well as internal
context and compiles all information related to QMS in the Issue Register.
● Once the issues are determined, they are reviewed periodically for applicability and impact.
● Positive Issues are supporting the organization’s activities and are strength. They may lead to some
opportunities untapped, which are updated in the Opportunities list in the document Risk and
Opportunities.
● Negative issues arising from internal context are weakness and is analyzed for the risk in the Risk
Register.
Drafted & Checked by: Approved by:
PAGE 1 of 2
Dsgn: AMR Dsgn: MR
Ref No.: I/WI/MGR/RM/001
WORK INSTRUCTION FOR
Rev No.: 00
RISK ASSESSMENT
Eff. Date: 15/01/2021
Understanding the Context - Needs and expectations of Interested Parties
● SEL identified interested party are customer, suppliers, service providers like calibration agency,
government or local authority that are relevant to the QMS and are listed in the Interested Party
Register. The description of the interested parties is also documented to understand them.
The HODs who interact with these interested parties review with MR determines the needs and expectation
and update in the Interested party Register.
● The needs are mandatory requirements that needs to be fulfilled. Those needs that are fulfilled are
regularly monitored as part of the Objectives monitoring monthly.
● The expectations which can be fulfilled are tabulated under opportunities and monitored.
Risk and opportunity for internal and external context and interested parties need and
expectation.
SEL does risks and opportunities related to external and internal issues, needs and expectations of
interested parties, which can affect SEL ability to achieve the intended outcomes of its QMS in
companywide level as well as department level.
Risk related to organization and QMS are ranked with severity and occurrence rating and index
(S*O) calculated.
Risk Priority 1: either severity= 3 or index S*O ≥ 6, Action plan to be taken immediately.
(Depicted in Yellow/Red color in below matrix)
Risk Priority 2: if index S*O < 6, no action required but monitored.
(Depicted in Green color in below matrix)
After action is taken, Severity (S) and Occurrence (O) to be re-determined and index to be in
Priority 2.
For Opportunities that are listed which are outcome of the positive issues which are untapped or the
expectations of interested parties not yet fulfilled. These are monitored and addressed in the current
year or subsequent year with consultation with MR and Top Management.
Reference : Refer RISK AND OPPORTUNITY REGISTER
Ref No. : I/RF/MGR/RO REG/003
Severity
1
1 2 3
Occurrence
Drafted & Checked by: Approved by:
PAGE 2 of 2
Dsgn: AMR Dsgn: MR
