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Quality Manual Sample
Quality Manual Sample
COPY NO. 01
DESIGNATION PARTNER / MR
This copy of Quality Manual is handed over to you. Please acknowledge the
receipt. In case you leave the organization, please return this copy to MR. If you find any errors,
kindly bring it to the notice of MR.
The documented Quality Management System is the sole property of DEVDATT INDUSTRIES.
Nobody shall reproduce it fully / partly without the written permission of PARTNER.
INTRODUCTION
DEVDATT INDUSTRIES is a small – scale industry situated at MIDC, Bhosari, Pune.
DEVDATT INDUSTRIES started its manufacturing activities in 2010. Presently company is
manufacturer of pressed, machined & fabricated components.
This manual describes the Quality Management System (QMS) as adopted & implemented by
DEVDATT INDUSTRIES to demonstrate that company meets the Quality Policy & Objectives. The
company has referred ISO 9001:2008 without design responsibility. It has been confirmed that the
exclusion claimed from QMS would not affect the organization’s ability or responsibility to provide
product that meets customer and applicable regulatory requirements. These documents together
with the Operating Procedures, Work Instructions & Blank Formats – makes the companies’s
QMS & are applicable to all departments.
EXCLUSION OF CLAUSES
Clause 7.3 - Design & Development
Justification: -
Since we manufacture machined metal components as per sample, drawings & specification
given by the customers, the design & development activity is not applicable to our company.
Therefore this clause has been excluded from our Quality Management System documentation.
03 Customer Customer Customers are those agencies who place their orders on
DEVDATT INDUSTRIES as per their requirements.
04 Product Product Product refers to the parts, which are manufactured as per
customer requirements & are dispatched to customers.
10 Internal Audit Internal Audit (IA) It is an on site verification activity based upon a sample used
with reference to QMS as per ISO 9001:2008 of all the
functions of DEVDATT INDUSTRIES
11 Calibration Calibration A set of operation which compare values taken from a piece of
Inspection Measuring & Test Equipment or a gauge to a
known standard under specified condition.
12 Quality Manual Quality Manual It is the DEVDATT INDUSTRIES document which describes the
scope & applicability of the elements of ISO 9001:2008. It also
interlinks operating procedures / Work Instruction / Blank
Formats as per requirements.
13 Quality Plan Process Plan These are the specifications as per customer required to
facilitate operators or In charge to work to meet the product
specifications.
14 Non Non Conformity It is a process which does not meet to QMS requirements
Conformity
15 Non Non Conformance It is that product which does not meet customers
Conformance specifications
REV NO : 00 REL DT : 01/04/2010
DEVDATT INDUSTRIES
TITLE: LIST OF DEFINITIONS & ABBRIVIATIONS
DOC. NO : QM/03 CL. NO. : -- PG. NO. : 02 of 02
AO AMENDMENT ORDER
B/D BREAK DOWN
BS BRITISH STANDARD
CAPA CORRECTIVE ACTION PREVENTIVE ACTION
C CLAUSE
CIR CONTINUAL IMPROVEMENT REGISTER
CP CONTROL PLAN
CSI CUSTOMER SATISFACTION INDEX
DI DEVDATT INDUSTRIES
DPIR DAILY PRODUCTION & INSPECTION REPORT
GIOR GOODS INWARD OUTWARD REGISTER
INSP INSPECTION
IA INTERNAL AUDIT
IS INDIAN STANDARD
ISO INTERNATIONL ORGANISATION FOR STANDARDISATION
M/C MACHINE
MAT MATERIAL
MF MANUFACTURING
MKT MARKETING
MME MONITORING & MEASUREMENT EQIPMENTS
MM MILLIMETER
MAINT MAINTENANCE
MR MANAGEMENT REPRESENTATIVE
MRM MANAGEMENT REVIEW MEETING
NA NOT APPLICABLE
NC NON CONFORMANCE
OFI OPPURTINITY FOR IMPROVEMENT
PFD PROCESS FLOW DIAGRAM
PM PREVENTIVE MAINTENANCE
PO PURCHASE ORDER
PP PROCESS PLAN
QF QUALITY FORMATS
QM QUALITY MANUAL
QMS QUALITY MANAGEMENT SYSTEM
R/W REWORK
REF REFERENCE
REJ REJECTION
REV REVISION
RIR RECIEPT INSPECTION REPORT
S SUPPLIER
S/C SUB CONTRACTOR
WI WORK INSTRUCTION
WIP WORK IN – PROGRESS
The organization has established, documented, implemented maintains Quality Management System &
continually improves its effectiveness in accordance with the requirements of this QMS as per ISO 9001:2008.
Each QMS document is uniquely identified as following:
XX/XX
1 2
Letters at 1 indicate type of document as under:
QM: Quality Manual
OP: Operating Procedure
WI: Work Instruction
QF: Quality Format
2. REL.DATE: This shows “Date of Release” either first issue or revision. It is also the date of Implementation
These processes are managed by the organization in accordance with the requirements of this QMS as
per ISO 9001:2008.
Where organization chooses to outsource any process that affects product conformity with requirements,
Organization will ensure the control over set processes. Controls of such outsourced processes will be
identified within QMS.
REV NO : 00 REL DT : 01/04/2010
DEVDATT INDUSTRIES
TITLE : GENERAL REQUIREMENTS
DOC. NO : QM/06 CL. NO. : 4.1 PG. NO. : 02 of 04
1. All related operations required for the manufacturing of a product have been established in our PFD
(QF/23).
2. The sequence & interrelationship between all the persons are also shown by organization chart
(QM/11 pg.11 of 11) & by internal communication (QM/11 pg. 10 of 11)
4. Following documents have been identified which are extremely needed for the QMS & their application
throughout the organization.
Quality Policy, Quality Objectives, Quality Manual, Operating Procedure, Work Instructions, Blank
Formats, Quality Planning documents like Customer / International / National standards, Customer
drawings, our Process Flow Diagrams, Process Plan.
Customers Quality Plan, Records required by ISO 9001:2008. {ref ML of Formats (QF/04) &} procedure
for Control of Records (OP/02).
b) Management Responsibility:
Management commitment, Customer focus (CSI – QF/21), Quality Policy, Quality Objectives, QMS
Planning, Responsibility, Authority & Communication, Management Representative, Management
Review Meeting.
c) Resource Management:
Provision of resources – List of Machine (QF/13), List of employees (QF/15), Skill matrix (QF/12),
Human resources, (Annual training plan, training effectiveness).
d) Production Realisation:
Planning of products realization (Production Planning, Customers PO/AO, Our quotation, purchasing
process, purchasing information, verification of purchase product, product realization & traceability.
Preservation of product (RM storage & packed final product), Control of monitoring & measuring
devices (Details of Measuring Equipment & Gauges (QF/37), Calibration certificate.
RIR (QF/09), DPIR (QF/25), PDIR (QF/35), MRM minutes, progress made through Quality Objectives,
Customer satisfaction Index (QF/21), Annual IA Plan (QF/32), IA CA Report (QF34), CC Register
(QF/22), NC register (QF/41), Supplier / Sub Contractor assessment form (QF/26) selection & their
performance report.
Receipt of enquiry / specification of the product from the customer (original or changed
requirements)
If No ambiguity, confirmation of PO
Control of Receipt of
to customer
Document Customer PO
Review of Customer
specification, quotation & If any mismatch, inform
Customer PO to Customer
Continued…
Receipt of purchase material & receipt inspection
4.2.1 GENERAL:
The company has established & maintained a Quality Manual which includes
a) Scope of the QMS, including details of & justification for any exclusion like Design &
Development 7.3.
b) Documented Procedure as per Master List of Operating Procedure (QF/02) established
for the QMS.
c) A description of the interaction between the process of the QMS (for e.g. Organization
chart (QM/11) pg. 11 of 11 & Process Flow Diagram (QM/06) pg. 03 & 04 of 04.
Following guidelines are referred to prepare documented procedure for Control of Documents
related to requirements of ISO 9001: 2008
Document requirements by the QMS are controlled. All requirements are controlled as required by
QMS. A documented procedure (OP/01) has been established to define the controls needed for
approving, reviewing, updating, changing, identifying current version maintaining, and all documents as
legible distributing to related functions and to prevent unintended use of obsolete documents.
For preparation & approval of various level QMS documents which are available in (WI/01) – WI for
Document control.
i. MR prepares & ensures that the Quality Manual, Operating Procedures, Work Instructions and Blank
Forms (Master Copy) are reviewed and approved by PARTNER; authorized MR releases Controlled
Copies.
ii. Following Master List with current revision status is retained function wise.
1. Master List of Operating Procedure (QF/02) – Responsible to update – MR
2. Master List of Work Instruction (QF/03) – Responsible to update – MR
3. Master List of Blank Forms & Formats (QF/04) – Responsible to update – MR
4. Contents of Quality Manual (QF/01) – Responsible to update – MR
iii. MR ensures that following documents are prepared and Reviewed / Approved by MR prior to issue of
Controlled Copy. All Quality Planning Documents (PFD, PP etc).
iv. MR is responsible to withdraw invalid or obsolete controlled copies from the point of use
v. On receipt of new standard, specification and changes the existing document & records are reviewed
and changes are implemented on all related internal documents. The same is applicable for internally
originated changes. The change effect on product is confirmed in PDIR and intimated to customers.
vi. The review of material at receipt, in process and finish goods is taken and request for deviation is
approved from customer for dispatching as per old modification.
vii. Customers inform about changes of Standards with current modification / date / year to DEVDATT
viii. Workers of DEVDATT INDUSTRIES may also suggest change to internally document.
ix. The changes in the document are identified by revision number which is updated to next number &
Records are established & maintained to provide evidence of conformity to requirements & for the
effective operation of the QMS. Records are maintained generally in hard copy form which are legible,
readily identifiable & retrievable. All the records are identified, stored properly, protected & disposed off
Ref.: 1) Operating Procedure for control of records (OP/02) – Includes List of Mandatory Records.
PARTNER provides evidence of its commitment to the development & implementation of the quality
management system and continually improving its effectiveness by
a) Communicating to the organization the importance of meeting customer as well as statutory &
regulatory requirements (by means of meeting etc.)
c) Ensuring that quality objectives are established, Ref: Quality Objectives (QM/10).
PARTNER ensures that customer requirements are determined and are met with the aim of enhancing the
customer satisfaction.
Customer P.O.
Customer schedule.
2) The Quality policy is defined and displayed in the plant and offices.
3) Quality Policy includes a commitment to comply with requirements & continually improve the
effectiveness of the quality management system
4) Quality Policy provides the framework for establishing & reviewing Quality Objectives.
6) The implementation and maintenance of Quality Policy & Objectives is ensured by periodical
auditing & reviews.
QUALITY POLICY
PARTNER ensures that Quality Objectives are relevant to Quality Policy of DEVDATT INDUSTRIES. These
Quality Objectives are established because these are needed to meet the product requirement also. These
Quality Objectives are established at related functions & levels within the company.
Quality objectives shall be reviewed as & when required based on business requirements & growth of the
organization. The Quality Objectives are measurable & consistent with Quality policy.
a) The planning of QMS is carried out in order to meet the requirements given in 4.1, as well as Quality
Objectives, Analysis of Quality Objectives (QF/18).
b) The integrity of the QMS is maintained when changes to the QMS are planned & implemented.
Ref: Procedure of Internal Audit (OP/03).
The Quality Manual covers the requirements of ISO 9001:2008. It contains Quality Policy &
Objectives of management and also describes a summary of Quality Planning done in line with clauses of ISO
9001:2008, which also provides guidelines to formulate operating procedures for each function. QM gives
Operating Procedures define the methodology of work carried out in functional areas.
Work Instructions define the method of doing specific task. Operating procedure give reference
Form & formats are used to generate Quality Record & Quality Planning documents. Filled
forms & formats contain the information as an evidence to prove that the quality management system adopted
by company is implemented and is effective. Above forms & formats show preparation and approval of
responsibilities as necessary. Minimum retention period for Quality Records are established, in line with ISO
9001:2008 and contractual requirements. Records are preserved for such defined period.
PARTNER ensures that Responsibility and Authorities are defined and communicated within the Company.
1. Inter relation of personnel who manage, perform and verify activities that affect quality.
2. Requirement of understanding customer needs meeting by way of MRM.
3. To convey the decision to next levels of personnel through various plans
and make them understand the same and to verify the implementations of decisions.
4. To stop production in case of product or process non-conformities through
Designated channels.
5. To maintain necessary quality records for any problems relating to the product process
and quality system.
ii) In addition to the above general responsibilities of employees, the specific responsibility of MR is also
defined.
iii) The authorities are defined considering executive requirement so as to accomplish the defined
responsibilities in order satisfy the quality system requirements. The responsibilities in order to satisfy the
quality system requirements. The responsibilities and authority of employee represents the needs of the
customer in internal functions in addressing ISO 9001:2008 requirements.
iv) Enclosed ‘Organization Structure’ shows the administrative hierarchy of officers within organization.
RESPONSIBILITY:
AUTHORITY:
RESPONSIBILITY:
MANAGEMENT REPRESENTATIVE:
The PARTNER Mr. Prashant Jawalkar has decided he himself will be the Management
Representative (MR) WHO IRRESPECTIVE OF OTHER REPONSIBILITIES HAS DEFINED AUTHORITY
FOR:
a) Ensuring that Quality System is established implemented and maintained in
accordance with applicable ISO 9001:2008 standard without design
responsibility & service provision.
b) Reporting on the performance of the Quality System to the management for
review & as improvement of the Quality System.
c) Ensuring the promotion of awareness of customer requirements through out
the company
The Management Representative (MR) also has an responsible for liaison with external parties on matters
relating to company’s Quality System.
AUTHORITY :
Designation: QA I/c
RESPONSIBILITY:
AUTHORITY:
Reporting To : PARTNER
RESPONSIBILITY:
AUTHORITY:
Designation: OPERATORS
RESPONSIBILITY:
AUTHORITY:-
1. 4.1 S P S S S S
2. 4.2 S P S S S S
3. 5.1 P S S S S S
4. 5.2 P S S S S S
5. 5.3 P S S S S S
6. 5.4 P S S S S S
7. 5.5 P S S S S S
8. 5.6 P S S S S S
9. 6.1 P S S S S S
10. 6.2 P S S S S S
11. 6.3 P S S S S S
12. 6.4 S S S P S S
13. 7.1 S P S S S S
14. 7.2 S S P P S S
15. 7.4 S S S S S P
16. 7.5 S S S P P S
17. 7.6 S S S P P S
18. 8.1 P S S S S S
19. 8.2 S P S S S S
20. 8.3 S S S S P S
21. 8.4 S P S S S S
22. 8.5 P P P P P P
P : Primary Responsibility
S : Secondary Responsibility
PARTNER ensures that appropriate communication process is established within the company by means
of Operating Procedure, Work Instructions, & Quality Records. PARTNER also ensures that
communication takes place regarding the effectiveness of QMS by means of MRM (QF/07)
Responsibilities & authorities of the personal in the Organization are communicated through MR. QM copy
& for down level, they communicates responsibility & authorities by verbally or showing QM copy
ORGANIZATION CHART
PARTNER PARTNER
Marketing / Purchase Production / QA / MR
Production / QA I/c
Operators
5.6.1 GENERAL
PARTNER reviews the company QMS at planned interval, every six months after Internal Audit,
to ensure continuing suitability, adequacy and effectiveness, however only 1st MRM is conducted after
1st Internal Audit. This review includes assessing opportunities for improvements and the need for changes
to the QMS, including the Quality policy (QM/09) & Quality Objectives.
b) Extraordinary MRM may be needed due to events like customer complaints / visits / audits /
increase in N. C. trends.
d) All management members are participant of the regular management review. For
extraordinary review MR decides participants & agenda.
a) Results of audits
b) Customer feedback
h) Review of Quality Policy, Quality Objectives & QMS for adequacy, suitability & effectiveness.
i) Supplier performance.
The output form management review includes any decision and action related to :
a) Improvement of the effectiveness of the QMS & its processes, by means of IA results.
a) To implement & maintain the QMS & continually improve its effectiveness by virtue of IA &
working for improvement in Quality Objectives.
Company makes the provision of resources (man, machine, material, method & money) as per customer
requirement by virtue of Minutes of MRM (QF/07).
6.2.1 GENERAL
It is ensured by the company that personnel performing work affecting product quality are
competent on the basis of appropriate education, training, skills and experience. Refer: List of Employees
(QF/15), Annual training plan & record (QF/10), skill matrix (QF/12).
The company
a) Determines the necessary competence for personnel performing work affecting product quality
Refer Training Record (QF/10).
b) Provides training or take other actions to satisfy these needs. Refer Annual Training Plan
(QF/10).
d) Ensures that its personnel are aware of the relevance & importance of their activities & how
they contribute to achievement of the quality objectives.
e) Maintains appropriate records of education, training, skills & experience in Skill Matrix (QF/12)
& reviewed yearly.
f) Competency level is decided for all designations, mentioned in Competency Matrix (QF/11).
6.3 INFRASTRUCTURE
The company determines, provides & maintains the infrastructure needed to achieve conformity to product
b) Process equipment (List of Machine QF/13), Details of Instrument & Gauges QF/37.
The company determines & manages work environment needed to achieve conformity to product
requirements by virtue of
b) Adequate resources.
c) Proper housekeeping.
g) Toilet.
The company plans & develops the processes needed for product realization as per customer’s
specification of product. Planning of product realization is consistent to the requirements of other
processes of the quality management system.
a) Quality objectives (QF /18) & requirements for the product as per customer specification.
b) The need to establish processes documents & provides resources specific to the product (for
e.g. all Quality planning documents like – PFD (QF/23) and Process Plan (QF/42), all
documented procedures.
c) Required verification, validation, monitoring, inspection & test activities specific to the product &
the criteria for product acceptance (for e.g. all quality records, calibration certificates, DPIR).
d) Records needed to provide evidence that the realization processes & resulting product meet
requirements. For e.g. all quality records of product inspection & continual improvement.
The output of this planning is available in the form of quality records as per company’s method of
operations.
b) Requirements not stated by the customer but necessary for specified or intended use,
where known, by virtue of purpose changes in the schedules for the delivery of the
products, dispatch destination as told by the customer verbally.
The company reviews the requirements related to the product with respect to availability of
resources and customer specifications. The review is conducted prior to the companies commitment to
supply a product to the customer. This done by sending quotation & receiving of customer P.O/A.O/
schedules.
The company ensures that
b) Contract or order requirement differing from those previously expressed are resolved
(verbal order register QF/08) &
c) The company has the ability to meet the defined requirements. This done by virtue of
reviewing & accepting customer P.O. The records of the results of the review are
maintained for each customer. Where the customer does not provide documented
statement of requirements, the customer requirements are conformed by the company
before acceptance in writing through letter.
Where product requirements are changed the company ensures that relevant documents
like PO / Customer specifications are amended and that the relevant personnel are
made aware of the changed products by means of verbal meeting / circulars.
The company determines & implement effective arrangements for communicating with customer in
relation to –
a) Product information by means of verbal discussion about dispatches & through PDIR (QF/35).
Since we manufacture as per the drawings, specifications given by the customers, the
design & development activity is not applicable to our company.
Therefore this clause has been excluded from our Quality Management System documentation
Generally open purchase order is released to supplier annually & monthly supply schedule is given verbally.
Purchase Order is issued only for purchasing above Rs.2000. Purchasing Order (QF/31) contains following
data as appropriate
i.) Description of material.
ii) Grade or other precise identification.
iii) Reference of specification.
iv) Rate & other commercial information.
v) Delivery schedule with instruction for 100% on time delivery.
vi) Inspection instruction, compliance to various Government safety & environment applicable rule /
regulation if any.
vii) Requirement of approval of product, Process, Equipment, Procedures, and other requirements.
viii) Packing, transport instructions.
ix) QMS requirement – if any purchase orders are reviewed for adequacy of above information before
releasing by PARTNER.
i) This is done by company, at company's premises for ensuring that purchased product meet
specified purchase requirements.
ii) As applicable verification is done at supplier / sub contractor end also. In this case relevant
purchase order indicates this requirement.
iii) If contractually required, verification by customer at supplier / sub contractor premises is
arranged. Relevant purchase order indicates this requirement.
However verification by customer does not become basis of acceptance by company. The company
ensures that components / products are conforming to requirements at receipts and dispatch stage.
The company plans and carries out production under controlled condition. The controlled condition includes
(as applicable)
1. The availability if information that describes the characteristics of the product (Quality planning
documents like customer drawing, PFD (QF/23), Process Plan (QF/42)
2. The availability of work instruction, as necessary (as stated in Master List of Work instruction –
(QF/03)
3. The use of suitable equipment (as stated in list of machines– QF/13).
4. The availability & use of monitoring & measuring devices (as stated in Details of Instrument –
(QF/37).
5. The implementation of monitoring & measurement by means of production report like DPIR (QF/25),
PDIR (QF/35), &
6. The implementation of release, delivery & post delivery activities by means of remarks on inspection
reports, delivery challan (QF/36).
i. Post delivery activity is defied as our scope of supply does not include servicing &
our responsibility ceases on acceptance of material by the customer except like
rejection, if any.
The organization validates any processes for production and service provision where the resulting output
cannot be verified by subsequent monitoring or measurement. This includes any process where deficiencies
become apparent only after the product in use or service has been delivered.
Validation demonstrates the ability of these processes to achieve planned results.
The organization has established arrangements for these processes including as applicable
A) Defined criteria for review and approval of the process,
B) Approval of equipment and qualification of personnel (Special process qualification report
QF/43)
C) Use of specific methods and products.
D) Requirements for records.
E) Revalidation is done if customer complaint received.
Presently a) Co2 Welding (Inhouse) identified for validation of process.
The company identifies the product by means of tags (QF/05) through out product
realization as appropriate. The company identifies the product status by means of the inspection reports.
Where traceability is a requirement, products of all customers are recorded the unique
The company takes care of customer property while it is under the company’s control or being
used by the company. The company will use tags / reports / bins / demarked areas etc. to identify, protect,
verify & safeguard customer property provide for use or incorporation into the product. If any customer
property lost, damaged or otherwise found to be unsuitable for use, it is reported to customer immediately by
means of letter, stock statements & its records are maintained. Present customer property are identified in
The company preserves the conformity of product during internal processing & delivery to the
This preservation includes identification, packaging, storage & protection preservation also apply to the
Following guidelines are referred to prepare documented procedure to control, calibrate and maintain,
inspection measuring and test equipment’s, used to demonstrate conformance of product to specified
requirements. As a policy, DEVDATT INDUSTRIES does not allow use of employee owned MME.
i. MME which directly affect Product Quality and used for control of process parameters are identified for
calibration.
ii. These are given unique identification numbers to track calibration status. Details of Instruments &
Gauges (QF/37) is made and it is updated depending upon addition or deletion of MME.
iii. Calibration Plan of Measuring Instruments & Gauges (QF/37) is made and followed to maintain
frequency of calibration.
iv. Calibration is done by approved calibration agency having calibrations standard traceable to recognized
national standard. The calibration data is validated against intended use and approves.
v. Inspection, measuring and test equipment are kept in respective boxes / original packing wherever
possible and safeguarded from adjustment which would invalidate calibration setting.
vi. If MME is found out of calibration, results of previous inspection are reviewed and appropriate action is
taken on MME and suspect products.
8.1 GENERAL
The company plans & implement the monitoring, measurement, analysis & improvement
processes needed
a) To demonstrate conformity of the product by means of inspection report like RIR (QF/09),
DPIR (QF/25) & PDIR (QF/35).
b) To ensure conformity of the Quality management system by means of MRM (QF/07) &
Internal audit results.
i) Every year, Customer Satisfaction Survey report (QF/20) is sent to each Customer & CSI
is calculated as per (QF/21).
ii) The target for achieving minimum CSI is defined in the format where this is not achieved,
then the action plan is prepared to arrive at customer’s dissatisfaction areas & actions
required for improvement to ensure to achieve minimum CSI.
iii) The company level Quality Objectives is studied & co-relation between customer
dissatisfaction area is established.
iv) CSI trend is calculated & presented in MRM (QF/07) along with action plan.
CRITERIA: Ensure that all clauses, processes & function have been audited. (Including MR function)
Following guidelines are referred to prepare documented procedure for planning and implementing Internal
Audits to verify compliance to Quality System.
A) Audit Frequency: Six monthly Internal Audits for all functions are carried out as per IA Plan for all clauses
by trained Internal Auditor; however only 1st internal audit is conducted before certification audit after 3
months of implementation of QMS. MR may decide to hold unplanned audits based on certain events
like, customer visit / customer complaints & rejection % age increased, target not meeting, follow up of
NC closure etc such audits shall be planned based on importance and status of related function.
B) References of checklists are available for auditing, which are appended considering specific event or
finding of previous audits. IA checklist (QF/33) to be used by each auditor at each audit.
C) Audit findings are recorded in internal audit & corrective action report (QF/34) and timely corrective
actions are taken by concerned person as planned.
D) Follow-up audit is done for verification of corrective action and its effectiveness. Records of Internal
Audits are maintained in internal audit & corrective action report (QF/34).
I) Audit findings are submitted in MRM for review.
J) Addition of Internal Auditors. During every MRM while discussing the status of Internal Audit, the need of
additional auditors is discussed. PARTNER is requested to nominate the officers to MR to organize Internal
Audit programs.
K) Annual IA Plan (QF/32) is prepared; accordingly Internal audit schedule (QF/30) for audit is released in
advance.
L) Frequency of audit is subjected to change due to any event. MR decides the change in frequency, which
is reviewed in MRM. This frequency is increased in case of increasing trends in Product / Process NC’s,
M) The internal auditors selected as he should be trained by certified lead auditor & as well as on the basis
of educational qualification / work experience. Ref : Operating Procedure for Internal Audit (OP/03)
The company applies methods for monitoring and, where applicable measurement the QMS
processes. This includes Internal Audit. These methods demonstrate the ability of processes to achieve
planned results when planned results are not achieved, corrective & preventive action are taken, as
The company monitors & measures the characteristics of the product to verify that product
requirements are met by means of inspection reports. The monitoring & measurements is carried out at
appropriate stages with respect to customer drawing of the product realization. Process in accordance with
the quality planning document of the company (e.g. PFD, PP). Evidence of conformity with acceptance
criteria is maintained in each inspection report. Inspection report indicates the person (s) authorizing release
Product release does not happen & until the planned arrangement have been satisfactorily completed,
unless otherwise approved by Production I/c or QA I/c or PARTNER & where applicable, by the customer.
The company ensures that the product which does not conform to product requirements is
identified by means of tag / demarked area / N.C. Register / Inspection reports and these non conforming
products are controlled to prevents its unintended use or delivery the controls & related responsibilities &
authorities for dealing with nonconforming products are defined in the documented procedure (OP/04)
The company deals with nonconforming products by one or more of the following ways.
b) By authorizing its use, release or acceptance under concession by PARTNER, and were
Records of the nature of the non conformities and any subsequent action taken, including
When N.C. product is corrected, It is re – inspected to demonstrate the conformity to the requirements
(e.g. N.C. Register– QF/41) when N.C. product is detected after delivery or use has started, company gets
information from customer then customer complaint register is updated & necessary CA & PA are taken.
a) Company has defined the continual improvement project (Quality Objectives) as per document
(QF/18) These are related to Quality operational performance, and current quality levels for key product
features. These Quality Objectives indicate past & current trends, including targets to be achieved.
b) Monthly data is collected by analyzing appropriate records available in company to compute the
Quality Objectives.
c) After studying earlier performance of the company & general industrial practices self – developed
benchmarks are decided for each Quality Objective. These are authorized by PARTNER.
d) The current status is discussed in every MRM. For Quality Objectives (QM/10), which are not as per
benchmarks an action, plan is prepared and followed (QF/18). Such action plan contains corrective &
preventive actions, which are taken in QMS through changes in OP documentation.
e) Priorities are given to improve Quality Objectives related to customer – related problems. For this the
dissatisfaction reported by customer are correlated with company Quality Objectives.
f) Decisions about additions/deletions about above indicators are taken during MRM. This also includes
up-gradations for any or all Quality Objectives targets.
The company continually improves the effectiveness of the QMS through the use of
Quality policy (QM/09), Analysis of Quality objectives (QF/18), Audit results / IA report (QF/34), Analysis of data
(QM/23) Corrective and preventive action and management review / MRM (QF/07)
The company takes action to eliminate the cause of nonconformity in order to prevent
recurrence. The corrective action taken are appropriate to the effects of the non conformities encountered
(e.g. N.C. Register (QF/41). An operating procedure (OP/05) has been established to define requirements for
c) Evaluating the need for action to ensure that non-conformities do not recur, by means of MRM.
The company determines the action to eliminate the causes of potential non conformities
in order to prevent their occurrence. Preventive action are taken which are appropriate to effects of the
potential problems. An operating procedure (OP/06) has been established to define requirements for
a) Determining potential non conformities and their causes (CA and N.C. Register QF/41)
b) Evaluating the need for action to prevent occurrence of non conformities (PA and MRM)
2 QF/02 Master list of Operating Procedure All concern Office 3 years 00 Doc
3 QF/03 Master list of Work Instructions All concern Office 3 years 00 Doc
4 QF/04 Master list of Forms & Formats All concern Office 3 years 00 Doc
29 QF/29 Cause & Effect Analysis All concern Office 1 year 00 Rec.