DOC. No.

QSM - 08
QUALITY SYSTEM MANUAL
REV. No. 00
MP MEASUREMENT, ANALYSIS & DATE 01.01.2013
IMPROVEMENT PAGE No. 1 of 6

8.1 GENERAL

The Organisation has planned and implemented the measurement, analysis and improvement
processes within the QMS as per the requirements of the standard to ensure that the product meets the
specified requirements. This process of planning and implementation is carried out on a regular basis
to ensure the following.
 Conformity of the product to specified requirements,
 Conformity of the QMS
 Continual improvement of the QMS

8.2 MONITORING AND MEASUREMENT

8.2.1 CUSTOMER SATISFACTION

 A well-defined system has been implemented in Mech Products to monitor information

related to customer perception through feed back as to whether the organization has
fulfilled their requirement or not
 A formatted questionnaire is used for determining customer satisfaction.
 The feedback obtained from customer is analyzed and suitable actions are taken to
eliminate dissatisfaction and to improve satisfaction further.

Reference:
CUSTOMER SATISFACTION SURVEY (F-MKT-02)

8.2.2 INTERNAL AUDIT – mandatory procedure

 Internal audits of the quality management system are conducted in once in 6 months.
 Audits are planned based on the importance of the activities.
 Additional audits are also scheduled based on the reports of internal /external audits and
changes to quality system requirement.
 All activities/processes are audited at least once in 6 months or as and when the need
arises.
 An Internal audit schedule is prepared by MR well in advance and intimates the schedule
to the auditor and auditee.
 Trained auditors, independent of the activity being audited as mentioned in the Master
List of Internal Auditors carry out audit.
 Auditors will not audit their own work.
 Before proceeding for conducting an internal audit, Internal Auditors are strictly advised
to learn and understand the relevant sections of the Quality System Manual and
respective work instructions.
 During the audit, deviations if any are recorded in Details of IQA NC reports and issued
to the auditee for taking corrective action.

The following actions are taken by the auditee once non-conformity is raised during an audit.
 An action taken to close the non-conformity raised immediately is called “Correction”.
 Root cause for the non-conformity is arrived at by a scientific method called as ‘Why-
Why analysis’.
 Ask why the non-conformity has occurred.
 Then, you will arrive at a reason.

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QUALITY SYSTEM MANUAL
REV. No. 00
MP MEASUREMENT, ANALYSIS & DATE 01.01.2013
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 Now, the auditee asks to himself the question on the reason given, why such reason is
told?
 This technique is continued for a maximum questioning of 5 times till a logical reason for
the problem is arrived at.
 This is called as “Root Cause”.
 After that, ask a question on the root cause, how to solve the root cause, which is your
Corrective Action.
 In totality, a non-conformity has occurred once but action taken to eliminate the non-
conformity by attacking the root cause is called as “Corrective Action”.
 Any action taken even before once the problem has occurred is called as “Preventive
Action”.
 The minor deviations and scope for further improvement is recorded in Audit Finding
Report.
 Auditee proposes corrective action with target date and implements corrective actions.
 Auditors / MR verify the implementation of corrective action through follow up.
 Audit and close the Non-conformities by writing comments.
 Follow up audit shall be done within a timeframe of one week maximum from the date of
conducting Internal Audit.
 Results of the audit are discussed in Management Review Meeting.

Reference:
F - MR - 04 INTERNAL AUDIT PLAN
F - MR - 05 INTERNAL AUDIT SCHEDULE
F - MR - 06 AUDIT FINDING REPORT
F - MR - 07 QUALITY OBJECTIVE DEPLOYMENT RECORD
F-MR-10 AUDIT SUMMARY REPORT

8.2.3 MONITORING AND MEASUREMENT OF PROCESSES

 Monitoring and Measurement of processes are carried out thro’ results of Internal Quality
Audits, Management Review, achievement of departmental quality objectives and thro’
the results of the 7 tools such as Cause and effect diagram and Pareto chart.

Reference:
AUDIT FINDING REPORT (F-MR-06)
MINUTES OF MANAGEMENT REVIEW MEETING (F-TM-04)

8.2.4 MONITORING AND MEASUREMENT OF PRODUCTS

 In order to assure conformity to customer requirements, the products are measured in

accordance with the Control Plan at various stages of the process. The acceptance criteria
are given in the above.
 In process Inspection report is maintained for the production

The responsible persons to release the products are

- Incoming products – Proprietor
- In process products – supervisor

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QUALITY SYSTEM MANUAL
REV. No. 00
MP MEASUREMENT, ANALYSIS & DATE 01.01.2013
IMPROVEMENT PAGE No. 3 of 6

- Delivery Stage – MR
 The authorization of release of product under deviation if any is also recorded. The
products are further processed only on acceptance of the product with respect to the
Control Plan.

Reference:
CONTROL PLAN (D-CP)
INPROCESS INSPECTION REPORT (F-QA-05)
FINAL INSPECTION REPORT (F-QA-08)

8.3 CONTROL OF NONCONFORMING PRODUCT – mandatory procedure

To ensure that non-conforming products identified at various stages are controlled, and not passed on
to next stage, or used unintentionally, organisation has established the following methods.
 All products whether incoming, in-process or finished are inspected as per the Process
Control Plan, to verify and ensure their conformity prior to use.
 The deviations to the specification in the Control Plan are considered as Non-conformity.

Incoming Products:
 All incoming products found NC are identified, rejected and returned to the supplier. For
customer supplied products, the NC will be informed to the customer and actions will be
taken as per their advice. It is the responsibility of the Propreitor.

In Process Products:
 The NC’s observed during in-process are kept separately and properly identified till a
decision of disposal action is taken. The Re-inspection is required on all reworked or
repaired material. Rework material must meet original requirements. Repaired material
must meet intended function and other requirements in accordance with customer needs.
This responsibility is with the Supervisor.

Finished Products:
 In case of NC’s observed in finished products in relation to the Control Plan the entire lot
is segregated and reworked. This is the responsibility of supervisor.

Post Delivery Products:

 Discovery of nonconforming material after delivery is immediately followed by the
actions necessary to minimize its impact and preserve customer satisfaction to the highest
level possible under the circumstances. It is the responsibility of MR.

 All Non-conformities are analysed for causes and suitable corrective action is taken to
ensure recurrence of the non-conformity. The details of action taken are recorded in Non-
Conformity Report.
Reference:
NON-CONFORMITY PRODUCT REGISTER (F-QA-07)

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MP MEASUREMENT, ANALYSIS & DATE 01.01.2013
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8.4 ANALYSIS OF DATA

 At the Organisation, the data generated as a result of monitoring and measurement, from
all sources, is collected and analyzed to demonstrate suitability and effectiveness of the
QMS.
 Evaluation of this data is used to show continual improvement of the QMS.
In order to achieve the above the following areas are covered and analyzed.

 Customer satisfaction: Periodical feedback received from customers.

 Scope for correction and prevention based on characteristics and trends of product and
process observed leading to continual improvement.
 Product conformity to requirements: Results of final inspection, in process inspection.
 Suppliers performance available thro’ suppliers monitoring and rating.
 Complaints received from customer are entered in Customer Complaint Register.
 Customer complaints are analysed by finding the root cause of the complaint and solving
it by taking appropriate corrective action or preventive action.
 The same is recorded in Non conformity Report.

Reference:
CUSTOMER SATISFACTION SURVEY (F-MKT-02)
CUSTOMER COMPLAINT REGISTER (F-MKT-03)
NON CONFORMANCE REPORT(F-QA-06)

8.5 IMPROVEMENT
8.5.1 CONTINUAL IMPROVEMENT

Continuous improvement in the effectiveness of quality management system is achieved

through the use of the following
 Well defined Quality policy
 Measurable quality Objectives
 Audits that identify opportunities for improvement
 Analysis of data of product conformance and process capability
 Customer satisfaction and supplier performance
 Corrective and preventive actions
 Management review
-
Reference:
QUALITY POLICY (5.3)
QUALITY OBJECTIVES (5.4.1)
AUDIT FINDING REPORT (F-MR-06)
CUSTOMER SATISFACTION SURVEY (F-MKT-02)
NC REPORT (F-QA-06)
MINUTES OF MANAGEMENT REVIEW MEETING (F-TM-04)

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 DOC. No. QSM - 08
QUALITY SYSTEM MANUAL
REV. No. 00
MP MEASUREMENT, ANALYSIS & DATE 01.01.2013
IMPROVEMENT PAGE No. 5 of 6

8.5.2 CORRECTIVE ACTION – mandatory procedure

 The IMD coordinates the corrective action (CA) to be undertaken by investigating the
causes of NC’s in the product to avoid recurrence.
 The MR coordinates the CA to be undertaken by investigating the causes of NC’s in the
process and the system to avoid recurrence.
 The extent of stress and control that will be put on the CA shall depend upon the impact
of the NC on the product, process or system and its consequent influence on other areas.
 Product related NC’s identified during inspection, is taken up for CA. For that NC
register and CA reports are maintained.
 The CA identified will be assessed for suitability prior to implementation and will be
verified subsequently for effectiveness.
 The document changes arising out of the CA will be taken up, as per the Control of
Documents. 4.2.3 in the manual.
 Information and feedback from the various processes and activities, internal quality audit
reports, customer complaints and feedback will be reviewed and NC’s will be reported to
the concerned personnel so as to investigate the cause and suggest CA.
 These are all recorded in the Non conformity report.
 The CA for quality system relates NC’s will be dealt as per the narration 8.2.2 in this
section.

Reference:
NC REPORT (F-QA-06)
CORRECTIVE ACTION REPORT (F-MR-08)

8.5.3 PREVENTIVE ACTION – mandatory procedure

 The IMD coordinate the preventive action to be undertaken by assessing the impact of
the potential NC’s in the process and the system to avoid any new problems from arising.
 The MR coordinate the preventive action to be undertaken by assessing the impact of the
potential NC’s in the product to avoid any new problems from arising.
 All information /feedback from various sources such as processes, production operations,
internal quality audit reports, customer feedback etc., shall be reviewed and the potential
NC’s will be reported to concerned personnel to investigate the cause and suggest
preventive action.
 The preventive action suggested will be discussed with other functionaries regarding its
effect in their areas.
 The potential NC’s with respect to product, process and systems will be discussed and
the possible preventive actions identified.
 From the identified solution the optimum PA will be implemented temporarily for study.
 The implemented action if found effective and useful will be incorporated into the
procedures / manuals appropriately for permanent implementation, through the
instructions for document change (4.2.3).
 In case the implemented action is found to be lacking in any way, an alternative action
will be identified and implemented.
 Product / process related PA’s, are based on the impact of CA’s on other related areas,
where, prevention helps avoid likely problems.

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QUALITY SYSTEM MANUAL
REV. No. 00
MP MEASUREMENT, ANALYSIS & DATE 01.01.2013
IMPROVEMENT PAGE No. 6 of 6

 All such actions taken based on the likelihood of problems arising and the consequent
prevention measures are recorded in the Non conformity Report.
 The PA’s once determined will be discussed prior to implementation and later verified
for effectiveness.
 All document changes arising out of the PA will be taken up as per the instructions for
document change (4.2.3).
 The PA’s for quality systems related potential NC’s will be dealt as per the narration
8.2.2 in this section.

Reference:
PREVENTIVE ACTION REPORT (F-MR-09)

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