100% found this document useful (1 vote)
332 views

Procedures

This document provides an index and overview of quality management system (QMS) procedures for BHL, including: 1. Procedure P-01 covers the management representative's responsibilities for controlling documents and records, conducting internal audits, and leading management reviews. 2. Key activities include maintaining master lists of documents and records, identifying controlled copies, conducting internal audits every 6 months, and reviewing audit results and customer feedback during semi-annual management reviews. 3. Procedure P-01 provides the document reference, responsible person, and effective date for 7 total QMS procedures that cover areas like production, purchasing, HR, and process validation.

Uploaded by

RajVardhan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
100% found this document useful (1 vote)
332 views

Procedures

This document provides an index and overview of quality management system (QMS) procedures for BHL, including: 1. Procedure P-01 covers the management representative's responsibilities for controlling documents and records, conducting internal audits, and leading management reviews. 2. Key activities include maintaining master lists of documents and records, identifying controlled copies, conducting internal audits every 6 months, and reviewing audit results and customer feedback during semi-annual management reviews. 3. Procedure P-01 provides the document reference, responsible person, and effective date for 7 total QMS procedures that cover areas like production, purchasing, HR, and process validation.

Uploaded by

RajVardhan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
You are on page 1/ 22

BHL INDEX FOR QMS PROCEDURE

EFFECTIVE
Sr PROCEDURE TITLE PROCEDURE NO. REV NO.
DATE

1 MR OFFICE P - 01 00 01.10.2012

2 CROSS FUNCTIONAL TEAM P - 02 00 01.10.2012

3 PRODCUTION & DESPATCH P - 03 00 01.10.2012

4 QUALITY ASSURANCE P - 04 00 01.10.2012

5 PURCHASE & STORES P - 05 00 01.10.2012

6 HUNAN RESOURCE MANAGEMENT P - 06 00 01.10.2012

7 PROCESS VALIDATION P - 07 00 01.10.2012

PREPARED BY APPROVED BY
QMS PROCEDURE DOC.NO.:P-01
BHL REV.NO.: 00
Title : MR Office PAGE NO.: 1/3
EFF.DATE: 01.10.12

Scope : a) Control of documents b) Control of records c) Quality objectives planning & monitoring
d) Internal audit e) Management review

Responsibility : Management Representative for all activities except control of drawings and specifications for
which Manager QA is responsible.
Topic S.No. Activity Document / Record
Ref/

Control of 1. All QMS documents are identified, prepared and approved by concerned WI/MR/01
documents authorities. Refer work instruction for document identification, preparation
approval and revision. All documents are issued by M.R.
2. Master copies of all documents are retained by M.R. by identifying them
as 'MASTER COPY' by means of rubber stamp on reverse of documents.
Controlled copies are identified as 'CONTROLLED COPY' on the face
of all document pages.
3. Master list of documents maintained including all QMS documents ML/03
except quality manual. The master list will indicate the current revision
status of each document, revision date and distribution (copy holders).
4. Master list of customer drawings also maintained identifying all parts ML/01
along with their child parts, customer drawing no., their revision status
and distribution (issue) details.
5. Master list of external origin documents also established to include all ML/02
customer given specifications, standards, industry and national standards
ISO standards etc. along with their revision status and distribution.
6. Whenever changes occur to any internal or external document, the
relevant master list is updated with current revision status. All old copies
are withdrawn from users and controlled copies of the current revision
re issued to them.
7. If required, master copy of the old revision is retained after identifying it
with 'OBSOLETE COPY' stamp on the face of the document. All such
obsolete copies are kept in a separate file.
8. Revisions to documents are carried out as per work instruction. Nature of
revisions made to all internal documents are identified and recorded as
follows : a) for in-house drawings - Revision table in drawing itself
b) For other documents e.g.Procedures, control plans, work instructions
etc. - In amendment history sheet which is maintained document
category wise by concerned incharges.

Control of 1. All QMS records are identified by means of their format nos. or title. A ML/04
Records master list of records maintained identifying all QMS records, responsib-
lity for update and maintenance and their retention time.
2. The records are either pen written or printed out and will be legible.
3. All records are maintained in files or in books identified with their title.
4. Records which are maintained in computer are duly identified with their
title or format no. Back up copies are taken in floppies once in a month
for such records. Anti virus software installed in all computers for record
protection.
5. Records which have crossed their retention period are disposed off.
Checking for retention period lapse is done once during January and
July every year.
PREPARED BY : APPROVED BY:

QMS PROCEDURE DOC.NO.: P-01


BHL REV.NO.: 00
Title : MR Office PAGE NO.: 2/3
EFF.DATE: 01.10.12

Topic S.No. Activity Document / Record


Ref/

Internal 1. Internal audit plan documented on a yearly basis identifying the depts., D/MR/02
Audit auditees, auditor and applicable requirements. Audit criteria and scope
shall be as per documented quality manual and procedures.
2. Audits are carried out by personnel (both internal / external) independent
of the activity being audited.
3. Audit frequency shall be atleast once in six months for each department
The frequency will be increased suitably if more than 3 non conformities
are observed in a department in a particular audit cycle. In such cases,
the audit plan is reviewed and revised by M.R. accordingly.
4. Audit observation sheet is used for recording details of samples audited F/MR/03
5. In case of minor observations or improvement points, auditee remarks
obtained in the observation sheet for rectifying the discrepancy.
6. If non conformities are observed (e.g. non compliance to procedures, F/MR/03
quality plans, product non conformity etc.), then internal audit NC report
is raised indicating the non conformity . Auditee agrees to take corrective
action within mutually agreed target date.
7. Audit summary report prepared at the end of the audit cycle. F/MR/04
8. Follow up made with concerned auditee by M.R. for taking timely
corrective action. The actions taken are verified for their implementation
and effectiveness and the NC closed out.
9. Internal audit summary report and results of customer and third party Audit results
audits conducted are submitted during MRM's and discussed(refer below).

Manage- 1. Management reviews are conducted once in six months. ED or COO


-Ment will be the chairperson of the meeting. The meeting will be organized by
Review M.R.
2. All department in charges are members of management review committee
and will be required to attend the meeting.
3. Agenda of management review shall be review of inputs such as results Also refer Quality
of audits (internal/external), customer feedback (satisfaction survey manual
results, complaints etc.), status of company objectives, status of
corrective&preventive actions, operational changes that could affect
QMS, and recommendations for improvement.
4. All concerned are informed well in advance of the MRM and are required
to compile necessary data and information related to their concerned
agenda points. Circulars are issued in this regard by M.R.
5. The various agenda points are discussed with the help of available trends
etc. and action points decided during MRM's. The action points or other
decisions made will be related to a) QMS & its effectiveness improvement
b) product improvement as per customer requirements c) resource
requirements.
6. Minutes of MRM along with action plans / decisions taken are recorded F/MR/01
in MRM minutes/action plan format.
7. Targets and responsibilities are assigned to the various actions points F/MR/01
decided during MRM. Such actions are followed up by M.R. for their
timely implementation and tracked in MRM minutes.
PREPARED BY : APPROVED BY:

QMS PROCEDURE DOC.NO.: P-01


BHL REV.NO.: 00
Title : MR Office PAGE NO.: 3/3
EFF.DATE: 01.10.12

Reference Documents :
1 Internal Audit plan - D/MR/02
2 Master list of components (customer drawings) - ML/01
3 Master list of external origin documents - ML/ 02
4 Master list of documents - ML/03
5 Master list of records - ML/04
6 Work instruction for document identification, preparation,approval & revision WI/MR/01

Retention period
Records : in months
1 Minutes of Management review meeting/Action plan - F/MR/01 24
2 Amendment history sheet - F/MR/02 12
3 Internal Audit report - F/MR/03 12
4 Audit NC Report - F/MR/03A 12
5 Audit Summary report - F/MR/04 12
6 Customer Satisfaction Survey form - F/MR/05 12
7 Documents Issue report - F/MR/06 12
8 Revision Record Sheet - F/MR/07 12

PREPARED BY : APPROVED BY:


QMS PROCEDURE DOC.NO.:P - 02
BHL REV.NO.:00
Department : Cross Functional Team PAGE NO.: 1/3
EFF.DATE: 01.10.12

Scope : a) Contract review b) New Part development c) Packaging Evaluation d) Quality costs
d) Supplier quality improvement, e) Supplier audits & rating f) Long term quality planning

Topic S.No. Activity Document / Record


Ref/

Contract 1) Inquiries received from customers along with drawings and/or master
Review sample is reviewed for completeness of specifications, manufacturing
Responsibility feasibility and other conditions through inquiry review checklist. F/DEV/01
Manager 2) If review indicates suitability, it is approved by the Plant Head.
Development 4) Customer timing requirements regarding part development, sample
submission etc. are obtained. Part development actities started.
(Refer section below ).
5) Customer purchase orders are reviewed for correct part no., drg, rev.no.
and rate against inquiry or previous purchase order. If clarifications are
needed, they are obtained from customer and the details are recorded in
order copies or in attachments.
6) Customer schedules are reviewed against by plant head against past
despatches. In case of significantly large schedule quantities, approval
obtained from CEO for making alternate arrangements such as extended
working hours in order to meet customer schedule.
7) After satisfactory review, the customer schedules are forwarded to
production & purchase incharges for planning production & purchases.
9) Order amendments other than engineering changes are reviewed for
suitability and actions taken and the records maintained.

New 1) Part development planning timing chart is made immediately upon F/DEV/02
Part satisfactory inquiry review and after obtaining customer timing
development requirements for sample submission etc.
Responsibility 2) Activities related to part development are identified including the following F/DEV/02
Manager as appropriate : a) Subcontractor selection b) Tool development c)Fixture
Development development c) Gauge development d) Documentation of control plans, Control Plans,
& review by process standards & instructions e) Updating other affected Work instructions
all CFT documentation f) Sample piece production and submission h)Preparation PCS & Process
members of reports as per customer requirements I) Pilot lot production j) Any sheets
other activity required to ensure part development that meets customer
requirements.
3) Responsibilities are assigned for each activity along with start and end
dates. The concerned personnel are informed. Completion of all such
activities are tracked and samples submitted to customer.
4) Suitable corrective actions are initiated when part development does not CAPA's
meet customer specifications or other requirements.
5) The part development activity is concluded on receipt of customer
purchase order and monthly schedule.
6) Packaging evaluation is also carried out before 1st production lot as WSP/09
per Procedure for the same and the records maintained. F/DEV/03

PREPARED BY : APPROVED BY:


QMS PROCEDURE DOC.NO.:P - 02
BHL REV.NO.:00
Department : Cross Functional Team PAGE NO.: 2/3
EFF.DATE: 01.10.12

Topic S.No. Activity Document / Record


Ref/

Quality 1 Quality cost analysis is carried out on a monthly basis. Cost of poor WSP/05
Cost quality and total quality cost are calculated as per methodology D/CFT/01
Analysis described in proceudre. Supporting reference data related to F/CFT/01
Responsibility scrap & rework costing, wages etc. are compiled and documented
Manager which serve as a reference for calculating various elements of quality
Development cost
2 Trends of total quality cost and other elements are maintained and
compared with monthly sales. Targets set for quality cost based on
available trends. Suitable actions initiated to meet targets. Status of
quality cost achievement discussed in MRM's.

Supplier 1 Critical parameters of purchased materials are determined and their Supplier reports
Quality result reports determined by obtaining supplier data.
Improvement 2 PPM levels of suppliers are also obtained (both internal & external)
and 3 Based on current levels, targets fixed for Cpk for each critical
Supplier parameter as well as for supplier inhouse & outgoing ppm/
Audit 4 Supplier quality improvement program documented identifying the D/CFT/02
Responsibility targets for Cpk and ppm. Suppliers communicated of the targets set
Manager and asked to take actions to achieve them.
Development 5 Monthly monitoring of supplier Cpk and ppm levels is undertaken.
Supplier CA requests are raised for unsatisfactory perfornances found
if any vis-à-vis targets set.
6 Supplier audit program documented in such a way that each supplier D/CFT/03
is audited atleast once in a year.
7 Supplier audit checklist established identifying various elements of F/CFT/02
quality system covering most of ISO 9000 requirements. Scoring
criteria established. Audits carried out as per schedule and scores
allotted. Suitable corrective actions are initiated using supplier CA
request format for major audit non conformances.
8 Supplier audit scores and quality improvement status are tracked and
reported in MRM's for discussion .

Long range 1 Long range quality plan for next 3 to 5 years documented by taking D/CFT/04
quality into account company's business plan, customer requirements,
Planning technological upgradation etc. Investments for quality improvement
Responsibility and expected results & targets form part of long range quality plan
Manager 2 The long range quality plan is implemented on an ongoing basis. Status
Development of implementatin is reported & discussed in MRM's.
PREPARED BY : APPROVED BY:

QMS PROCEDURE DOC.NO.:P - 02


BHL REV.NO.:00
Department : Cross Functional Team PAGE NO.: 3/3
EFF.DATE: 01.10.12

Reference Documents :
1 Supporting reference data for quality cost calculation D/CFT/01
2 Supplier quality improvement program D/CFT/02
3 Supplier audit program D/CFT/03
4 Long Range Quality Plan D/CFT/04
5 Work Instruction of Packaging evaluation WSP/09
6 Procedure for Quality Cost Analysis WSP/05

Retention period
Records : in months
1 Inquiry Review checklist - F/DEV/01 Till part is active
2 Part Development planning timing chart - F/DEV/02 -- do --
3 Packaging Evaluation report - F/DEV/03 24
4 Quality Cost Analysis Report - F/CFT/01 12
5 Supplier Audit checklist - F/CFT/02 24

PREPARED BY : APPROVED BY:


QMS PROCEDURE DOC.NO.:P - 03
BHL REV.NO.:00
Department : Production & Despatch PAGE NO.: 1/3
EFF.DATE: 01.10.12

Scope : a) Production planning,control, b) Packing & despatch


c) Product Identification & Traceability d) Machine Maintenance

Topic S.No. Activity Document / Record


Ref/

Production 1 Planning for despatch and production is done on a daily basis as per
planning customer requirements for the current date and next day respectively.
& 2 Previous day's Closing stock of products before and after painting
Control stages are taken into account while planning current day production.
3 The plan is discussed in daily meetings and recorded in production log. F/PROD/01
4 Follow the FIFO for production material at all stages.
5 Production of condensor tubes and AMT are carried out as per their PFD/product code
respective process flow diagrams.
6 Work instructions are documented for all process operations and are WI/PROD/01 TO
displayed near the operation areas. The work instructions describe the WI/PROD/15
methods for operation setup, sequence, caution points, inspection
instructions and acceptance criteria.
7 For special processes such as spot welding, painting, D/PROD/01A,B,C,etc
spec sheets/control standards are documented and adhered. The
spec sheets /control standards specify the process parameters,
specifications, monitoring method and frequency of check.
8 First part approval carried out for all process operations by the production
supervisor. The records of first part approvals maintained in respective
production register or in FPA report (for spot welding), In case of Operator F/PROD/06
change or setting change or any major breakdown.
9 Details of production, non conformances, their reasons & dispositions F/PROD/02 TO 09
carried out are maintained in respective stage wise production register.
10 Daily non conformance summary report is prepared indicating stage wise
non conformances, rework and scrap quantity etc. and the same
forwarded to QA. (also refer procedure for QA).
11 In addition to the above, documents such as length chart, approved
chemicals list (at decoiling stage), work instructions for auxiliary bending
and painting rework (at final stage) are also documented and are referred
to ensure processing as per customer requirements.
Responsibility : Production Supervisor
Packing 1 Packing is carried out as per work instruction for the same. Packing
& standard is also documented as per customer requirements indicating
Despatch details of packing materials, pack quantity etc. The packing standard is
updated
2 Details of production at each stage, packing & despatch are summarised F/PROD/01
and maintained in production log book.Packing details are maintained in F/PROD/07
packing register.
3 Adequate care is taken while handling & loading materials for despatch.
All despatches are made only after clearance from QA after predespatch
inspection.
PREPARED BY : APPROVED BY:

QMS PROCEDURE DOC.NO.:P - 03


BHL REV.NO.:00
Department : Production & Despatch PAGE NO.: 2/3
EFF.DATE: 01.10.12

Topic S.No. Activity Document / Record


Ref/

Product 1 Raw materials (tubes) are identified with identification tags with spool no. ID Tags
Identification indicated on them. After decoiling, bundles are made of 50 each and
and the bundles are identified with tags. The spool no. is transferred to the
Traceability bundle tag.
2 The spool no. is carried through all operation stages upto leak testing
and identification is done by means of tags. Materials put on hold or
termed for rework are kept separately and identified with yellow tags and
materials which are termed as scrap are identified with red tags.
3 At preheating and painting stages, lot traceability is maintained by means
of lot control registers. Refer work instruction for traceability.
4 After final inspection and packing, the products are identified with WI/PROD/15
packing stickers indicating product code, description, quantity, date Packing slips
and spool no. (traceability no)

Machine 1 List of machines & equipment documented and maintained. D/PROD/04


Maintenance 2 Preventive machine maintenance checklists documented for each type of
machine. Daily, weekly & monthly checkpoints for each machine type F/PROD/9A,B,C
are identified and checklists documented. Quarterly,Halfyearly and F/PROD/10 A,B,C,
annual checkpoints are also identified and another set of checklists
documented for each machine type.
3 PM checklist shall be included the m/c manufacturer recommendations.
4 Preventive machine maintenance carried out as per respective checklists
at appropriate frequencies.
5 Machine history cards established for each machine. Breakdowns F/PROD/11
and other problems occurring in machines are immediately attended to
and the records of down time and other details such as spare
replacements etc. are maintained in respective machine history card.

Reference Documents :
1 Process Flow diagram - Condensors PFD/WOT CON
2 Process Flow diagram - AMT PFD/AMT CON
3 Specification Lists D/PROD/01A,B,C
4 List of Approved Chemicals D/PROD/02
5 Packing Standard D/PROD/03
6 List of Machines and Equipment D/PROD/04
7 Work instruction for Decoiling, Straightening & Cutting WI/PROD/01
8 Work instruction for Airblow WI/PROD/02
9 Work instruction for Flaring WI/PROD/03
10 Work instruction for Serpentine bending WI/PROD/04
11 Work instruction for Wire cleaning WI/PROD/05
12 Work instruction for Wire Filling WI/PROD/06
13 Work instruction for Spot Welding WI/PROD/07
14 Work instruction for Leak Testing WI/PROD/08
15 Work instruction for PT and Painting WI/PROD/09
Contd…
PREPARED BY : APPROVED BY:

QMS PROCEDURE DOC.NO.:P - 03


BHL REV.NO.:00
Department : Production & Despatch PAGE NO.: 3/3
EFF.DATE: 01.10.12

Reference Documents (Contd..) :


16 Work instruction for Packing WI/PROD/10
17 Work instruction for Traceability WI/PROD/11
18 Work instrcution for Auxiliary bending WI/PROD/12
19 Work instruction for Painting rework WI/PROD/13
20 Work Instruction for Condenser Hanging WI/PROD/14
21 Work Instruction for Set Up/ Set Down WI/PROD/15
22 Traceability Sequence of process D/PROD/05

Retention period
Records : in months
1 Production Log Book - F/PROD/01 3
2 Decoiling register - F/PROD/02 3
3 Bending register - F/PROD/03 3
4 FPA for spot welding - F/PROD/04 3
5 Leak Testing Production register - F/PROD/05 3
6 Pretreatment and Painting Lot control register - F/PROD/06 3
7 Packing register - F/PROD/07 3
8 Identification tags 3
9 Packing stickers 3
10 Welding Process Validation - F/PROD/08 12
11 Preventive machine maintenance checklists ( Daily, Weekly, Monthly ) -
F/PROD/9A,B,C etc. 3
12 Preventive machine maintenance checklists ( Quarterly, Halfyearly & Yearly ) -
F/PROD/10A,B,C etc. Till lot is in use
13 Machine History card - F/PROD/11 With material
14 Break Down Memo Slip - F/PROD/12 3
PREPARED BY : APPROVED BY:
QMS PROCEDURE DOC.NO.:P - 04
BHL REV.NO.:00
Department : Quality Assurance PAGE NO.: 1/4
EFF.DATE: 01.10.12
Scope : Receipt inspection & Supplier quality rating, Inprocess inspection, SPC, Final inspection, Product,
Dock audit, Calibration and Gage R&R, Control of non conforming product & Data analysis,
Corrective and Preventive action & Problem solving techniques, Engg. & Process changes
Topic S.No. Activity Document / Record
Ref/
Receipt 1 All incoming raw materials such as Tubes,Wires, Paints & Caps are Part/family control
Inspection inspected and tested for various parameters as identified in respective plan (CP/sl.no.)
& part/family control plan. The control plan also specifies inspection method
Supplier and sampling plan. Suitable work instructions are documented and (WI/QA/01&02)
rating followed for lab testing (e.g. IR & moisture testning)
2 The results are recorded in incoming inspection report & lab test report F/QA/01 & 02
Responsibility 3 If non conformances are identified, the details are recorded in report and
Manager QA all non conforming material sent back to supplier. In case urgent
requirements, seggregation is done and OK materials accepted.
4 Line rejections due to vendor fault are identified and the details recorded F/QA/03
in line rejection note. The materials alongwith line rejection note are
forwarded stores on a weekly basis for sending them back to supplier.
5 Supplier quality rating is calculated every month on the basis of F/QA/04
quantity supplied and quantities rejected at receipt stage and inprocess
stage (GIN rejection + line rejection). The rating forwarded to purchase.
6 If any Supplier's Quality Rating achieving 100% for continuous 1 year, then
that supplier for that particular product is to be reviewed for Free Pass &
after Free Pass if it fails then again reinspection will be carried out for 1 year
7 Supplier corrective actions are initiated whenever rating falls below 90%
(refer topic : corrective and preventive action)
Inprocess 1 Inprocess inspection inspection is carried out at each stage with a F/QA/05
inspection sample size of 5 pcs per shift. Stagewise inprocess inspection checklist
& SPC established which identifies inspection parameters & specifications
which are derived from the control plan.
Responsibility 2 If problems / non conformances are identified, immediate containment F/QA/05
Engineer QA actions taken. If required, corrective actions are also initiated. (refer
below). Details of non conformances/problems, actions taken etc. are
recorded in inprocess inspection report.
3 Process capability study plan is established identifying the parts,special D/QA/01
characteristics under SPC study, frequency and sample size. Data F/QA/22
collection is carried out as per the process capability study plan
4 Control charts are used for determining process stability. If process is Control chart(Xbar&R)
found to stable (no out of control points or non randem pattern), then Cpk study report
process capability (Cpk) is calculated using minitab software.
5 Corrective actions are initiated whenever Cpk is less than acceptance WI/QA/03
criteria or less than initial Cpk during PPAP (FPA) submission. Refer
work instruction for process capability study
Final 1 Final (predespatch) inspection is carried out before packing. Control Control plan
Inspection plan is referred to for carrying out final inspection. BHL sampling plan WI/QA/04
and Product, is followed for selecting sample sizes and the acceptance no. C=0 in
Dock audit all cases (irrespective of sample size).
2 Results of final inspection are recorded in PDI report, a copy of which is F/QA/06
Responsibility sent to customer along with despatch lot.
Engineer QA 3 Final packaged product audit is carried out at predefined frequencies D/QA/02
(atleast once per month for each part) as per dock audit schedule. All
the product & packaging parameters are inspected using dock audit F/QA/07
checklist.
4 Product Audit is carried out atleast once in 2 months for one model as F/QA/20
per checklist. Review on same audit is to be done in meeting/MRM
5 If any NC observed at Dock Audit, that complete Lot will be kept as HOLD
& complete lot should be reverify as per requirement.
6 Immediate corrective actions taken for non conformances found either
in final inspection or in dock audit.

PREPARED BY : APPROVED BY:

QMS PROCEDURE DOC.NO.:P - 04


BHL REV.NO.:00
Department : Quality Assurance PAGE NO.:2/4
EFF.DATE: 01.10.12

Topic S.No. Activity Document / Record


Ref/

Calibration 1 Master list of instruments & gauges established identifying each IMTE D/QA/03
& with unique code. Calibration frequency decided depending upon usage
GRR and acceptance criteria established as 10 times that of min. tolerance
of all the specifications the instrument/gauge is intended for usage.
Responsibility 2 All instruments / gauges are externally calibrated through NABL
Manager QA accredited and approved labs (refer purchase). A calibration schedule D/QA/04
is maintained for this purpose.
3 Calibration traceability with respect to national masters is verified upon Calibration
receipt of calibration certificate. certificates
4 If error is more than acceptance criteria, the instrument/gauge is either --do--
discarded or sent for repair. Otherwise, error stickers are employed.
5 GRR study plan is documented identifying all instrument families, D/QA/05
schedule of study, characteristic to be used for study, responsibility etc
GRR study for each instrument familiy is carried out once in six months.
6 GRR for Variable and Attribute gages are carried out using respective F/QA/08
formats. Work instruction is referred to for appraiser selection, study WI/QA/05
methodology, acceptance criteria and action guidelines.
7 Suitable corrective actions are taken whenever GRR not ok for any
instrument family as per work instruction.

Control of 1 Details of non conformances at receipt stage are recorded in incoming F/QA/01 &02
Non inspection report and supplier rejections in line are recorded in line
Conforming rejection note. All NC materials are returned back to supplier.
Product & 2 Materials urgently required for production but without receipt inspection
Data are released Under Deviation by taking approval from HOD QA, Samples
Analysis from same material lot are retained for inspection in such cases and the
inspection carried out before despatch of finished product which
Responsibility incorporates the Deviation incoming material.
Manager QA 3 Non conformances identified in all process areas during production, Stage wise prod/rej.
& all QA first piece inspection etc. by production personnel are recorded in register (refer Prod.
prod staff respective stage production register. Daily non conformance report procedure)
prepared by production incharge and forwarded to QA indicating stage F/QA/10
wise NC's and the disposition carried out (either rework or scrap).
4 NC's identified during final inspection/dock audit are recorded in
respective reports and immediate disposition & corrective actions taken.
5 On every Supected components put a yellow (HOLD) tag & do the
Inspection by thorough process & then certify the components.
6 Details of customer complaints/returns recorded in customer complaint F/QA/11
register. Disposition decided and corrective actions initiated.
7 Reaction plan of control plan is referred to for determining disposition Control plans
of NC's occurring due to various characteristics at various stages.
8 Summary of internal and external rejections prepared every month and F/QA/12
ppm' calculated for internal (stage wise & overall) as well as for external.
Non conformance Trends and data are forwarded to quality planning for Trend charts
the purpose of quality cost analysis and target setting.

PREPARED BY : APPROVED BY:

QMS PROCEDURE DOC.NO.:P - 04


BHL REV.NO.:00
Department : Quality Assurance PAGE NO.:3/4
EFF.DATE: 01.10.12

Topic S.No. Activity Document / Record


Ref/

Corrective 1 Corrective actions are initiated on suppliers under the following situations
and a) any lot rejection b) if more than 2 lots are subjected to segregation
Preventive in a month for any supplier c) if quality rating of any supplier is < 90%..
Actions and 2 In such cases, supplier CA request form is filled detailing the nature of
Problem the problem and the form sent to supplier. Supplier asked to investigate
Solving the root cause of the problem and take actions to eliminate the same.
Methods 3 The form is received back and effectiveness of actions taken by supplier
are verified by means of monitoring subsequent supply performances.
Responsibility 4 Corrective actions are initiated for in-process problems using CAPA format F/QA/14
Manager QA in the following cases: a) If a nonconformance is found severe in nature
at the discretion of Manager QA b) If daily % NC at any stage is higher
than 1.5 times than that of targets set (refer quality planning procedure)
c) If Cpk of any parameter found < acceptance criteria or PPAP Cpk
5 Corrective actions are initiated for all customer complaints & returns F/QA/14
using CAPA format.
6 Whenever corrective actions are taken, root cause analysis is done WI/QA/06
using problem solving methods such as pareto analysis, cause & effect
diagram, brain storming etc. Refer work instruction for use of problem
solving methods.
7 Actions determined to eliminate root cause and prevent reoccurence of
the problem Responsibilities & target dates assigned and the implemen-
-tation tracked. Effectiveness of actions taken verified by checking
the output of subsequent lots and ensuring whether problem is eliminated.
8 If during root cause analysis of an existing problem, potential problems
and their root causes are also identified, then preventive actions are
initiated on such potential problems in order to prevent their occurrence.
9 Preventive actions are also taken based on data analysis, trends, control
charts etc if they identify a potential problem
10 Status of corrective and preventive actions taken are discussed in MRM's.

Engineering 1 Details of Engineering changes received from customer are recorded in F/QA/19
& ECRR format. Feasibility review carried out. Actions to be taken in (ECRR format)
Process product,tooling, process alongwith documentation activities are identified,
Changes responsiblities and targets assigned and implemented.
Responsibility 2 Date of change implementation in production and reference of 1st supply
Manager QA after change are recorded in ECRR format & tracebility of same is to be
maintained & informed to the cusomer for reference (also for Deviation Lot)
3 Process changes may be identified and initiated under following situations
a) When improvement opportunities are identified b) While reacting to
customer complaints/feedback c) as a part of engineering change
d) technological upgrdation
4 Changes to process flow, equipment, tooling, methodology shall be F/QA/19
treated as process change. In such cases, ECRR format is raised (ECRR format)
detailing nature of process changes, activities to be implemented etc.
The implementation & its results are tracked to ensure that the objectives
of the process change are achieved.

PREPARED BY : APPROVED BY:

DOC.NO.:P - 04
BHL QMS PROCEDURE REV.NO.:00
PAGE NO.:4/4
Department : Quality Assurance EFF.DATE: 5.1.13

Reference Documents :
1 Control plan CP/sl.no.
2 Work Instruction of Internal Residue test WI/QA/01
3 Work Instruction of moisture test WI/QA/02
4 Work instruction for Process Capability Study WI/QA/03
5 Sampling plan WI/QA/04
6 Work instruction for Paint Viscosity Check WI/QA/05
7 Work instruction for Humidity Test WI/QA/06
8 Work instruction for Salt Spray Test WI/QA/07
9 Work instruction for Impact Resistance Testing WI/QA/08
10 Work instruction for Paint ThicknessTesting WI/QA/09
11 Work instruction for Bath Titration of Wire cleaning & Pretreatment WI/QA/10
12 Process Capability Study Plan D/QA/01
13 Dock Audit Schedule D/QA/02
14 Master list of Inspection, Measuring and Test Equipment (IMTE) D/QA/03
15 Calibration Schedule D/QA/04
16 GRR Study Plan D/QA/05

Retention period
in months
Records : 1 Goods Inspection Report - F/QA/01 6
2 Lab test report - F/QA/02 12
3 Line rejection note - F/QA/03 6
4 Supplier Quality rating report - F/QA/04 12
5 Inprocess inspection report - F/QA/05 6
6 Process capability study report - F/QA/22 1
7 Final (PDI) Inspection report - F/QA/06 12
8 Dock audit checklist - F/QA/07 12
9 GRR study report - F/QA/08 12
10 Check Sheet - Cutting Section - F/QA/09 12
11 Inprocess Rejection Report - F/QA/10 12
12 Customer complaint record - F/QA/11 12
13 Monthly Rejection summary (External) - F/QA/12 6
14 Check Sheet - Serpentine Bending - F/QA/13 12
15 Corrective and Preventive action report (CAPA format) - F/QA/14 12
16 Check Sheet - Welding Section - F/QA/15 12
17 Check Sheet - Due Point Temp - F/QA/16 12
18 Check Sheet - Leak Testing - F/QA/17 12
19 Check Sheet - Push Pull Meter - F/QA/18 12
20 Engineering Change Review Report (ECRR) - F/QA/19 Till next change
21 Product Audit Checklist - F/QA/20 12
22 Inprocess Rework Report - F/QA/21 12
23 External Calibration certificates Till next calibration
24 Supplier material test certificates 12
25 External materials test certificates 12

PREPARED BY : APPROVED BY:


QMS PROCEDURE DOC.NO.:P - 05
BHL REV.NO.:00
Department : Purchase & Stores PAGE NO.: 1/2
EFF.DATE: 01.10.12
Scope : a) Supplier evaluation, selection and reevaluation.
b) Purchase orders c) Purchase planning, scheduling and delivery performance monitoring
d) Receipt and finished goods stores
Responsibility: Purchase - Purchase incharge
Stores - Store incharge
Topic S.No. Activity Document / Record
Ref/

Supplier 1) Whenever a new supplier is identified, details of their activities and facilities F/PUR/01
evaluation, are obtained in supplier registration form. If found necessary, visit made to
selection supplier premises to observe and collect information.
& Re- 2) Evaluation comments are recorded in registration form. If supplier is found
evaluation suitable, approval obtained from Plant Head and trial order placed on them.
3) If trial lot passes Q.C. inspection on receipt, the suppplier is approved by
giving reference of trial lot in the registration form.
4) Approved supplier list is maintained including all kinds of suppliers and service D/PUR/01
providers. The list is revised & updated whenever any supplier is included or
deleted. The list & revisions to it are approved by CEO.
5) In case of service providers such as calibration agency, material testing Introductory letter
agency etc. introductory letter is obtained and verified for capability and from service provider
suitability. Evaluation comments written on the letters by concerned incharge.
Approval obtained from plant head and the service provider is included in
approved supplier list.
6) All existing suppliers are included in the approved supplier list on the basis of
past experience.

Purchase 1) Purchase planning for next month is done at last week of current month. Next F/PUR/02
planning month customer schedule, if available is taken as the basis for purchase plan.
Otherwise current month schedules are considered.
2) Purchase plan is made by referring to a) Bill of materials b) inventory report D/PUR/02
obtained from stores c) minimum stock requirement. Purchase quantity
calculated accordingly. Order quantity determined by plant head. F/STR/06
3) Where Order quantity is more than the calculated requirements, suitable
remarks are given by the plant head and the purchase plan approved.

Purchase 1) Purchase orders are released for all approved suppliers on a monthly basis. F/PUR/03
Ordering The orders will clearly indicate the description of the item ordered, references
& to drawings, inspection standards etc. Where not applicable, complete
performance specifications are indicated in the purchase order itself.
monitoring 2) Requirements of test certificates and 100% on-time delivery are also indicated
in the purchase orders.
3) Actual deliveries made by supplier are tracked. Delivery rating calculated for F/PUR/04
each item/supplier every month. Quality rating obtained from QA and overall
rating calculated.
4) Suitable corrective actions are taken on suppliers by sending supplier CA CAPA format
request format to them and asking them to investigate the causes and take
actions to rectify the delivery problem under the following cases:
a) Overall rating for any supplier is less than 70% in a single month or less
than 90% for consecutive two months.
b) Very poor delivery rating (below 50%) in a single month.

PREPARED BY : APPROVED BY:


QMS PROCEDURE DOC.NO.:P - 05
BHL REV.NO.:00
Department : Purchase & Stores PAGE NO.: 2/2
EFF.DATE: 01.10.12

Topic S.No. Activity Document / Record


Ref/
7) The actions taken by the supplier are verified for effectiveness if their
further delivery ratings are found satisfactory.
Responsibility : Stores incharge
Stores 1) Details of all incoming materials are entered in material inward register. The
materials are verified against respective purchase order and delivery schedule
for description and quantity.
2) The materials are kept in under inspection area and are identified with tags. Identification tag
Q.C. personnel informed to carry out receipt inspection.
3) GIN raised accordingly indicated quantity received, accepted and rejected GIN
The GIN's are approved by Manager QA. Accepted quantity is moved to
main stores or issued to shopfloor. Rejected quantity is kept in rejection area
duly indicated with red tags. Suppliers informed to lift rejected materials.
4) Stock ledgers maintained for each incoming material. They are updated for F/STR/03
each receipt and issue as per FIFO and balance stock indicated. All issues F/STR/04
to shopfloor are done through issue slips with FIFO way method.
5) Always First In material to be issued (First Out) to production.
6) Materials sent out for jobwork are issued through returnable challans. Party F/STR/05
wise job work status (issue, receipt & balance) is maintained.
Material required date is indicated in returnable challan. Delivery rating done
for jobwork suppliers by tracking supplies within required delivery dates
7) All goods are stored properly in racks or bins or trolleys in order to avoid any
damage or deterioration during storage. Material receipt date and expiry date
(Shelf Life items) are indicated for all items. Issues made before the expiry date.
8) Handling, Storage and Preservation of materials in stores is done as per WI/STR/01
work instruction for the same
9) Stock condition assessed on a monthly basis by verifying quantity and
physical condition of stock.Monthly stock report generated and forwarded F/STR/06
to production incharge for doing purchase planning.
10) All Expired or Obsolete material will be considered as a Rejection & should be
kept in Non -Confirming (Rejection) Area & disposal action of same should be
taken.

Reference Documents :
1 Approved Supplier list - D/PUR/01
2 Bill of Materials - D/PUR/02
3 Work Instruction for Handling, Storage & Preservation - WI/STR/01 Retention period
Records : in months
1 Supplier Registration Form - F/PUR/01 Till supplier active
2 Purchase Plan - F/PUR/02 12
3 Purchase Order - F/PUR/03 12
4 Supplier rating report - F/PUR/04 12
5 Material inward register - F/STR/01 12
6 Goods Inward Note ( GIN) - F/STR/02 12
7 Issue Slip - F/STR/03 12
8 Stock ledger - F/STR/04 12
9 Returnable / Non returnable challan - F/STR/05 12
10 Monthly Stock Report - F/STR/06 12
PREPARED BY : APPROVED BY:
QMS PROCEDURE DOC.NO.: P - 06
BHL REV.NO.: 00
Department : Human Resources Management PAGE NO.: 1/1
EFF.DATE: 01.10.12

Scope : Competency, Training & Effectiveness Evaluation of all employees

Sr Activity Document / Record


No. Ref/

1. Personnel competency criteria documented for all levels of employees. D/HR/01


Required competency in terms of educational qualification, relevant work
experience, skill sets, required training are identified and documented.

2. Personnel competency record is maintained in computer for all levels of F/HR/01


employees which indicates their actual qualification, experience, skill sets
and training attended by them.

3. Training required is identified by comparing personnel competency record D/HR/02


as against the criteria documented. Annual training program documented
in which training topic, attendees, faculty and training schedule for the year
are indicated.

4. Training organised and conducted as per training program. Individual training F/HR/02
record is maintained for all staff and training attendance sheet is maintained F/HR/03
for all operators.

5. Effectiveness of training given is verified after completion of one month F/HR/05


from the Training by the respective Department Head or M.R. or plant Head
& the results of the Training effectiveness review is to be recorded.
done & all this

6. Re training or suitable management action taken if training effectiveness


not found satisfactory.

7. Absentism of all employees to be calculated & reviewed on monthly basis

8 Skill Matrix of all employees to be made as per sectionwise by dept head F/HR/04

Reference Documents :
1 Personnel competency criteria - D/HR/01
2 Annual Training Program - D/HR/02

Records : Retention period


in months
1 Personnel competency record - F/HR/01 Permanent
2 Individual training record - F/HR/02 Till employment
3 Training attendance sheet - F/HR/03 24
4 Training Feedback sheet - F/HR/03A 12
5 Skill Matrix - F/HR/04 12
6 Training Effectiveness Review - F/HR/05 12

PREPARED BY : APPROVED BY:


QMS PROCEDURE DOC.NO.: P - 07
BHL REV.NO.: 00
Department : Process Validation PAGE NO.: 1/1
EFF.DATE: 01.10.12

Scope : Process Validatio is applicable for all special processes i.e. Spot Welding, Pretreatment and Painting
Operator qualification is also applicable for spot welding process.

S. No. Activity Document / Record


Ref/

1) Process validation for special processes is carried out in the following


cases : a) new part b) changes in part specifications which are generated
by the special process c) new machine/equipment d) after any major
repair or overhaul to existing machine/equipment.

2) Situations requiring process validation shall be identified during new part


development, engineering change review etc. by CFT. Other situations as
described above are identified by production incharge and communicated
to Manager - QA.

2) Acceptance criteria for process validation shall be determined by selecting


key product parameters such as weld strength, Reliability Test,
Paint peel off,Surface finish, Appearance etc. depending on the type of
process and customer requirements.

3) Various trials are taken under different values of the identified process F/PROD/08
parameters and the product is inspected as per acceptance criteria.

4) The process is considered validated for the trial in which the product Process
passes inspection. The process specifications are included / updated in sheets
process sheets, control plan and other affected documents. Records Control
of process validation is maintained in process qualification record. plans

5) Revalidation of process is to be done after 1 year for all welding m/c's & if
Rew/Rej qty rise than 50000/25000ppm resp. for continuous 3 months.

6) For spot welding, Welder approval is carried out for a) all new welders and
b) once in a year for all existing welders.

7) The welders are asked to weld 5 nos. of the selected assembly.


Visual, fitment & weld strength testing is carried out for all 5 pcs.
The operator is qualiified if all the pcs are found ok. Otherwise, retraining
nd requalification carried out.

8) Records of operator qualification are maintained.

Reference Documents :
None

Records : Retention period


in months
1 Process Validation record - F / PROD / 08 Till next validation
2 Operator qualification record

PREPARED BY : APPROVED BY:

You might also like