RC 2022 Summary CAFD

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Audit Summary Report QSP-11/F-10

Organization Central Analytical Facility Division


Address(es) Dte of System & Services, PINSTECH, P. O. Nilore, Islamabad
Contact Person Mr Kashif Naeem Position Head CAFD /MR
Phone 051-9248772 Fax -
Audited 1. ISO 9001:2015 2. 3.
Standard(s)
Audit Date(s)/ From: 29-09-2022 To: 30-09-2022 Two Days
Duration
Audit Type Stage 1 Audit Stage 2 Audit Surveillance (No1/2)
Recertification Follow up Special Audit
Transfer
Lead Auditor Zeeshan Ahmad Abbasi Team Member(s) 1. Ejaz u Haq
2.

Technical Mr. Zeeshan Ahmad Interpreter


Expert/Shariah Abbasi /Evaluator -
Expert
Certification Scope:
(scope statement must be verified and appear in the space below)
Provision of Analytical Services to establishemnts of PAEC, Public & Private Sectors for
Chemical Charaterization of Metallurgical, Biological, Geological, Petrochemical and
Enviromental Samples by advanced analytical techniques and classical chemical methods.
Exclusions 8.3 Design & development of products & services
8.5.1 (f) Validation of processes
8.5.3 Property belonging to customer/external provider (w.r.t external
provider property only)
No of Corrective Action Requests (CARs) Major - Minor - Observations 10
Is a follow up visit Date of follow up
Yes - No - -
required visit
Follow up visit remarks
N/A
Audit Summary
Re-Certification Audit of M/s Central Analytical Facility Division - (CAFD, PINSTECH) as per
requirements of ISO 9001:2015 QMS is conducted on 29 th & 30th Sept, 2022 by audit team
comprising of Zeeshan Ahmad Abbasi (Lead Auditor) & Ejaz ul Haq (Auditor).

CAFD is government organization working under Pakistan Atomic Energy Commission with
defined scope specified above. The organization is headed by Mr. Muhammad Rafique Sheikh-
Dir Systems & Services Dte., PINSTECH. The organization comprises of about 07 officers & 14
technical staff.

The organization’s quality management system is in place since June 2010. At present Quality
Manual (CAFD-GE-QML-02-001), Rev 03, dated 4 th Feb 2022 is applicable. There is no change in
scope of Quality Management System since conduct of last certification audit. The

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Audit Summary Report QSP-11/F-10

organization has claimed non applicability of clause 8.3 Design and Development of Products &
Services & clause 8.5.3 Property belonging to customer/external provider (w.r.t external
provider property) & clause 8.5.1 (f) validation of processes. The justification for non
applicability reviewed and found satisfactory. The performance over 3 year certification cycle
reviewed and found satisfactory.

The compliance to following procedures was assessed implemented as per requirement of


ISO 9001:2015 and found satisfactory;
 Quality Manual (CAFD-GE-QML-02-001)
 QSP for Control of Documents & Records (CAFD-GE-QSP-04-001)
 QSP for Internal Auditing (CAFD-GE-QSP-04-002)
 QSP for Management Review (CAFD-GE-QSP-04-005)
 SOP for customer related processes (CAFD-GE-SOP-04-004)
 QSP for Risks and Opportunities (CAFD-GE-QSP-04-009)
 The organization has also established & maintained the Divisionwise ISO folders /
manuals, containing SOPs, W.I’s and plans to cover the technical requriements of QMS.

The internal & external issues are specified in Annexure “B” of Manual. The issues included
space constraints, untrained staff, electric shutdowns, delay in supply of gases etc. The positive
issues included motivated team, strong customer focus and advance analytical techniques. The
interested parties have been specified in the Annex C of Manual like customers, employees,
top management, PNRA, QAD/CeSP & community & their requirements have been specifed.
The internal, external issues & requriements of interested parties is used as input for risk and
opportunity management process. The organization established the mechanism to address risk
& opportunities that are addressed through QSP for QSP for Risks and Opportunities (CAFD-
GE-QSP-04-009) & Risks & Opportunity Record (CAFD-GE-RCD-06). Finding has been raised
related to risk assessent process.

The organization conducts internal audits & management reviews on annual basis. Last
internal audit was conducted on 6th October 2021 resulting in to 02 x observations. Last
Management Review was conducted in Dec 2021 and agenda items like adequacy of
resources, quality objectives, previous management reivew actions, audit results, customer
feedbacks, process performance etc has been discussed and tasks assigned to the concerned.
Findings has been raised related to internal audit & management review process.

Top management (Head CAFD, Mr Kashif Naeem) and CAFD team found committed for
implementation, maintenance & improvement of quality management system. Mr. Kashif
Naeem is also working as MR of organization, supported by DMR (Mr. Munib Ahmed).

The audit was conducted in a friendly & cooperative manner where access to required
information and documents was provided quickly. The Re-certification audit, conducted

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Audit Summary Report QSP-11/F-10

through a sampling mechanism revealed nil minor non conformance & 10 x observations.
Unresolved Issue (If any)
Nil
Observations
1. Last MRM conducted on Dec 2021 however non conformances and corrective action
related to services not discussed. Performance of external provider (calibrtion service
provider) like NPSL not disussed.
2. Last year audit finding (Obs # 5) has been partially addressed by revising QSP for Risk &
Opportunity (CAFD-GE-SOP-04-009) however following observed
 Risk threshold value of 9 to reviewed for applicability
 Risk assessment sheet (CAFD-GE-RCD-06-026) as per revised SOP is not
implemented in one of the section ( however action initiated during
assessment)
3. One of the objective in Chromatography group for year 2021 (CAFD-CH-QOB-02)/2021
related to E.Coli technique development was partially achieved but achievement plan
remarks column showed full completion. The action like raising of non conformances
may be initiated or mechanism may be defined in case of non achievement of
objectives.
4. Calibration reports exist at user department, however in case of micropipette
calibration (CAFD-CH-EQ-04), reference to standard/method used was not found
clearly speciified.
5. Data analysis of tests conducted is being carried out however data analysis w.r.t KPI
was not availble e.g with referernce to no. of samples & related benchmarks of KPI (No.
of days of reporting & type of sample (Ore, water etc)). This may also be discussed in
MRM.
6. Internal Auditor Selection criteria is not specified clearly in the Internal Audit Procedure
e.g w.r.t minimum experience, minimum no of days of internal audit training.
Observation addressal mechanism be clearly specified in the internal audit procedure.
7. Customer Feedback Form (CAFD-GE-RCD-06-021)/ Customer related processes
threshold value for taking of corrective action be specified clearly.
8. Last audit observation # 11 related to expiry of reagents etc is partially addressed. The
responsibilities of concerned to be specified clearly e.g identification of such chemicals,
their labelling/identification further usage etc. The Verification Record Sheet of
Chemicals (CAFD-GE-RCD-06-030) not endorsed by concerned through verifiable
signature. However action initiated during assessment.
9. Competency Assessment Sheet (CAFD-GE-RCD-06-020) is referred in the QSP for
Training ( CAFD-GE-QSP-04-003) in heading “Record” however its description in
methodology (main body of procedure) not specified.
10. Following observed with reference to Issue Log & Needs and Expectation of Interested
Parties in Annex-B & C of Quality Manual
Annex-B Issue related to use of obsolete technology for training
Annex-C needs and expectation of supplier w.r.t “product & price awarenss”

Opportunity for Improvement (If any)


Nil

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Audit Summary Report QSP-11/F-10

*Use extra sheets if required

Conclusion / Recommendation:
The organization is recommended for re-certification based on ISO 9001:2015 (Quality
Management System) for the scope and location given in this report.
This audit report is confidential and distribution is limited to audit team, client representative
and CeSP Office.
Lead Auditor: Client’s Representative:

Name: Zeeshan Ahmed Abbasi Name: Mr. Kashif Nadeem (Head CAFD / MR)

Signature: Signature:

Date: 30th Sep, 2022 Date: 30th Sep, 2022

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