• What isAn Audit?
“An Audit is a systematic, independent and documented process for
obtaining audit evidence and evaluating it objectively to determine the
extent to which audit criteria are fulfilled.”
or
“ It is a systematic and independent examination to determine whether
quality activities and related results comply with the planned arrangements,
and whether these arrangements are implemented effectively and are
suitable to achieve objective”.
This definitions is given in:-
ISO 9000:2005 Quality management system
Basics
5.
• Objective:- Whyto perform an Audit?
To check:-
Desired qualities and specifications of Assy./Sub.Assy./End product.
Whether equipment's are working properly or not.
Whether specified quality procedures are being followed or not.
The quality system element are adequate with regard to specified
requirements.
Opportunities for improvement.
For preventive action.
For outstanding emphasis on customer satisfaction.
Basics
Process Audit
It isan audit of the process(manufacturing) to ensure accuracy in the
manufacturing of product at first attempt.
It examine the resources e.g. equipment, material, people, storage
condition etc.
It provides improvements in the manufacturing process by observing
the nature of defects occurred and trying to minimize it.
It gives the scope for preventive action.
17.
Documents reviewed duringprocess audit
System related documents:-
i. Procedures for implementation and maintenance of QMS
ii. Work Instructions/SOP
iii. Forms and Formats
Product and service related documents:-
i. Drawing/Specification/Flow Chart/Instruction charts
ii. Process Schedule/technology sheets
iii. Quality Assurance Plan(QAP)/QAI/ATP etc.
iv. Inspection schedule, Gauge schedule, Proof schedule
v. The documents, record for NABL Accredited lab as per IEC 17025
18.
Process Audit executionsetup
In Ordnance factories
1) Internal Process audit:-
To ensure that specified processes are followed at every stage of
production in Ordnance factories, an internal Quality Audit group(QAG)
of each factory has been entrusted to carry out process audit as well as
audit of Quality system in factories as per the guidelines issued time to
time by OFB.
2) External process audit:-
It is done and programmed by DGQA agency e.g. CQA(OFV), time to
time as per their sop (No.01847/OFB/secy(Dp)/DGQA/Tech
cord(16TC) ,14 Aus 2014).
It is basically based on customer feed back, High frequency defect
report reviewed by them time to time.
19.
OFB common guidelinesto
QAG for process audit
A) For Planning of process audit:-
QAGO/QCO to prepare Quarterly audit progrqmm by selecting at least
one assy./sub-assy./product in consultation with Sr.GM/GM for audit
every month.
Priority to be accorded to assy./sub-assy./product having higher
failure/RFR.
Plan will be such that all the major/critical assemblies should get
audited in a year.
20.
OFB common guidelinesto
QAG for process audit
B) For conducting the process audit :-
Input material inspection as per specification/drawing.
Availability of TOT/ AHSP documents(latest version).
Availability of updated Process Schedule, QAP & Gauge Schedule & their
conformance to TOT/ AHSP documents
Manufacturing process (including process parameter) w.r.t process
schedule.
Stage and final inspection as per QAP/Process Schedule.
Inspection documents and records.
Identification mark on components sentenced RFR.
count……….
21.
OFB common guidelinesto
QAG for process audit
B) For conducting the process audit :-
Non removable identification mark on rejected component at all stages
of inspection.
Integrity of entries in NQDBMS.
Storage, Pocking & Dispatch w.r.t. Specification/Process Schedule.
Calibration of Gauges & Testing Equipments.
Any other non-conformity observed.
22.
OFB common guidelinesto
QAG for process audit
C) For Making Reports and Remedial measures:-
All the non-conformities to be recorded in tabular form with a column
for Remark/PDC of DO/GO/CO of audit area. (In general practices 15days
PDC is given from the date of audit report distributed. for special occasion
like procurement, major failure etc. PDC can be extended as intimated by
concerned Do/GO.)
Complete report to be sent to QAGO and Sr.GM/GM. QAGO will also
verify/monitor/cross check removal of non-conformity.
Non conformities to be again verified every month by QAGs and pending
points to be brought to the notice of Sr. GM/GM & QAGO.