Form No: SMSPL/QF/04

Rev- 00; Date: 19/07/2021;

AUDIT SUMMARY REPORT

Department / Section Audited Audit Ref. No: 2023/01

SMSPL Laboratory,Paredip Date of Audit: 02/11/2023 & 03/11/2023

Scope of Audit Reference Standard / Procedure:

1.Lab Technical team ISO/IEC 17025:2017
2.Management team
3.Administrative team No. of NCR Major Minor Observation
02 - 02 -

Assessment summary:
SMSPL compliance to ISO 17025:2017 was reviewed & the lab functionality (Admin/Lab./Management).
The assessment team has verified the laboratory management system & its operations.
Documental evidence for the functioning of the lab was audited for implementation of the quality
management system.

4.1 Declaration of impartiality & appointment letters found as evidence

4.2 Confidentiality as code of ethics & vendor confidentiality agreement available.
5.0 Laboratory has adequate infrastructure & valid legal identity.
6.2 Training of personnel done as per plan. Competency matrix & Competency record available at
laboratory.
6.3 Laboratory maintain records for environmental condition.
6.4 Master list of equipment available, Measuring equipments are calibrated.Intermidiate check of Hot
air Oven(SMSPL/PDP/MIN/HAO/02) for the month of October 2023 not available.(NC-01)
6.5 Master list of CRM with traceability available in the laboratory.
6.6 Procedure QP-04 described. Vendor registration ,evaluation ,supplies inspection records are
available..
7.1 All tests done as per TRF. Sample handed over to lab with sample forwarding memo.
7.2 National/International standard method for test are followed. Verification of test method recorded.
7.4 Procedure (QP-06) for handling of test item available.
7.5 Technical records are maintained by laboratory.
7.6 Measurement of uncertainty calculation done for all scope.
7.7 Laboratory has conducted ILC program, IQC checks etc. Lab has participated in PT program also.
7.8 Test report prepared & authorized by Lab manager.
7.9 No Complains received till date.
7.10 Procedure (QP-10) described for handling non-confirming work.
7.11 Authorized persons are access the data. Computers are protected by password. No LIMS software
used in laboratory.
8.1 Laboratory has selected Option-A.
8.2 Laboratory prepared Quality Manual, Quality procedure & implemented in all lab operations.
8.3 The documents in the laboratory are issued , authorized & revised as per system requirement.
Laboratory has the standard books of currents version of testing method.
8.4 Procedure(QP-11) available. Laboratory maintain the documents or records are indexed, stored &
protected in all aspects.
8.5 Laboratory operate its work on risk management process in QM-8.5. Risk register updated.
8.6 Lab conducted or participated in ILC, IQC & PT program. Laboratory has performed the work of
the customer ‘M/S Mitra SK pvt Ltd’ . But has not any records regarding its services or
Communications. (NC-02)
8.7 Procedure (QP-10) is available. NABL surveillance audit was held on 14/05/2023.. CAR available in
SMSPL-LAB-QM-7 file.
8.8 Internal audit conducted once in a year. Las audit : 12-13/12/2022.
8.9 Last MR meeting held on 16/01/2023.

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 Form No: SMSPL/QF/04
Rev- 00; Date: 19/07/2021;

AUDIT SUMMARY REPORT

Assessment team comment on compliance of laboratory to:

All the team members are co-operative & very familiar to the laboratory activities. The team
members are aware of ISO/IEC 17025:2017 standards & its requirement. Lab has implemented
the quality management systems by well maintaining Quality policy,Manual & Procedures.

Recommendations:

Need to fulfil the requirement as per ISO/IEC 17025:2017 & work with continual improvement of
laboratory management system.NC (02 nos.), Minor raised during this audit need to close by
lab in 15 days.

Auditor Name: Mr Saswat Ranjan Barik Mr Tapan Behera

Signature :

Date : 03/11/2023 03/11/2023

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