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Section 8.

5 of ISO/IEC 17025:2017

Risks and Opportunities

SBI/SBC shall consider the risks and opportunities either concerning the
management issue or the technical issue that address to:
a) give assurance that the management system can achieves its intended result;
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement;
e) eliminates or minimizes a risk to impartiality.
Actions taken to address risks and opportunities shall be proportionate to the
potential impact of the validity of laboratory actions and the quality of laboratory
results.
SBI/SBC shall plan:
1) Actions to address these risks and opportunities.
2) How to:
a) Integrate and implement the actions into its management system process.
b) Evaluate the effectiveness of these actions.
Effective action plans shall be developed, implemented and monitored.
The Head of Department is responsible for evaluating preventive actions and
determines if the preventive action is effective. Then further preventive action
shall be applied as necessary while the opportunities for improvement will also
be endeavoured.
Records of preventive actions to address risks and opportunities shall be
maintained as a quality record and shall be reviewed by SBI/SBC Management
during the management reviews of the management system.
INTERNAL AUDIT
To ensure to integrate and Implement the actions into companies IMS Internal
Audit will be carried out
GENERAL
SBI/SBC shall carry out internal audits at a predetermined interval in order to
ensure that its operations continue to comply with the requirements of the
laboratory’s policies and procedures and to guarantee that there is no breach to
any applicable requirements of the ISO/IEC 17025.
The internal audits must cover every aspect of the requirements of the
management system of SBI/SBC including the measurement.
Details of Procedure for Internal Audits are described in IMS Procedures.
AUDIT INTERVAL
The internal audits are carried out on annual (every six months) basis or when a
potential deficiency in the Management System has been encountered through
means other than an audit.
RESPONSIBILITY
The Quality Manager is responsible for the planning, organization and conduction
of internal audits. The Quality Manager may appoint any laboratory staff who is
qualified as an audit officer(s). It is the policy of SBI/SBC that laboratory staff
are not permitted to audit their own activities. Additionally, He / she shall ensure
that all corrective actions required by the audit results have been completed
within agreed time scale.
AUDIT PERFORMANCE
Audit shall be performed in accordance with approved procedures. Auditors shall
have access to previous audit results to aid audit preparation.
All aspects, both management and technical, of the quality system including the
activities.
Objective evidence shall be examined carefully to determine if the system
elements are effectively implemented.
The area of activity audited, the audit findings, corrective actions and follow – up
audit activities that arise from them shall be recorded.
AUDIT RESPONSE
When the audit findings cast doubt on the effectiveness of the operation or on
the correctness or validity of the laboratory’s measurement results, the Head of
Department shall notify customers in writing if investigations show that the
laboratory results may have been affected.
8.5 Actions to Address Risks and Opportunities(Option A)

Probability
Severity

Risk
S.No Laboratory Activity Difficulty Solution

Only well trained and experienced Technician should write


No proper detailing of sampling on sample slip and the full details of sampling slip and collect enough sample
1 Sampling 3 3 9
Not enough quantity of sample for testing for testing. The sample details will be entered in the
Sampling Register Immediately as per our IMS Procedures
Not good quality sampling bags, Transport of Sufficient number of bags are to be used. Enough capacity
2 Sample Transport 2 1 2
cement concrete cylinders and Asphalt Mixture box filled with wet sand is to be transported slowly
Riffling operations are to be performed under the
Preparation of sample for
3 No proper sample preparation 3 2 6 supervision of technician as per the procedure mentioned in
testing
test method
Calibration schedule to be checked regularly as per IMS
4 Test Equipment Calibration 3 1 3
formats
Only experienced Technician will carry out testing and Test
5 Testing Wrong test procedure 3 3 9
Standard should be available for reference always
Test results will be checked electronically and Manually on
6 Reporting Wrong calculation 3 3 9
regular basis by Sr.Technician and Laboratory Manager
Evaluation of the test results always be made by Laboratory
7 Evaluation Limited knowledge of technician 3 3 9
Manger
Submission of Test Results to Before submission of test report ,the reports will be checked
9 Different reports 3 1 3
Clients by laboratory manger
10 Test Equipment Break down 3 1 3 New equipment in use
Key people leaving the job,absent during the work Rest of the team members are trained enough to handle
11 Technicians 3 2 6
in progress works during the absence of key people.
Severity Level Probability
Low-1 1 2 3
Medium-2 Severity 1 1 2 3
High-3 2 2 4 6
Probability 3 3 6 9
Low-1
Medium-2 Low Risk
High-3 Medium Risk
High Risk

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