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FO-2015-0
8.0
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Section : 8.0
Revision: 2
Page: 1 of 11
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8.1
: Dedy Kurniadi
General.
Measurement and monitoring activities required to assure product conformity,
and to achieve improvement, are planned and defined. When applicable,
statistical techniques are used for analyzing measurement data.
Pipamas plans and implements the monitoring, measurement, analysis, and
improvement processes (including statistical controls) needed to;
Demonstrate conformity to product requirements,
Ensure conformity of the QMS, and
Continually improve the effectiveness of the QMS.
The effectiveness of the quality system is monitored by internal audits and by
measuring quality performance, corrective and preventive action, continual
improvement activities and customer satisfaction. Results of these activities are
reported to the executive management in management reviews and are used to
identify opportunities for improvement. Activities related to internal audits and to
measuring customer satisfaction and quality performance are further defined in
this manual in Sections 8.2.
8.2
8.2.1
Customer Satisfaction
Customer satisfaction is measured by collecting and analyzing direct
customer feedback, and by measuring secondary indicators of customer
satisfaction. Customer satisfaction data is used by the executive management
to identify opportunities and priorities for improvement.
Customer satisfaction is the principal objective of the quality system, and the
level of customer satisfaction is the most important measure of the
effectiveness of the system.
8.2.2
Internal Audit
All activities and areas relevant to the quality system are audited at least once
a year. Audits are scheduled on the basis of the status and importance of the
activity. Internal auditors are independent of those having direct responsibility
for the audited activity. Identified nonconforming conditions are brought to the
attention of the responsible managers and corrective actions are implemented
in response to audit findings.
Quality Manual
FO-2015-0
8.0
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Section : 8.0
Revision: 2
Page: 2 of 11
Signature
Signature
: Dedy Kurniadi
Pipamas carry out internal quality audit to verify that quality system
requirements and procedures have been effectively implemented and complied
with and to determine the effectiveness of the quality system.
The Quality Management Representative (QMR) shall be responsible for the
company's quality audit program. Audits shall be scheduled and all systems and
procedures shall be audited at least once a year.
Audits shall be performed by qualified personnel independent of those who
performed or directly supervised the activity being audited.
The results of the audits shall be documented and brought to the attention of
the management personnel having responsibility in the area audited and shall
take timely corrections and corrective actions on the deficiencies found by the
audit.
Corrections and corrective actions taken shall be verified to ensure they are
effectively implemented before being recorded and closed.
As a rule, audit results shall be surfaced and discussed in the Management
Review meetings.
When planning audit, all previous audits result finding shall be taken into
consideration.
The Quality Management Representative (QMR) establishes an internal audit
plan and schedule and audits are performed according to Operating Procedure
(OP24: Internal Audit).
Internal audits shall be scheduled and conducted at least annually by The
Quality Management Representative (QMR) who performed or directly
supervised the activity being audited.
Pipamas identify response times for addressing detected nonconformities and
10 days are allowed for response otherwise Quality Assurance Manager will be
notified to facilitate obtaining a satisfactory response.
8.2.3
Quality Manual
FO-2015-0
8.0
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Section : 8.0
Revision: 2
Page: 3 of 11
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: Dedy Kurniadi
Quality Manual
FO-2015-0
8.0
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Section : 8.0
Revision: 2
Page: 4 of 11
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Signature
: Dedy Kurniadi
features
to
monitor
and
measure
the
Results of inspections and tests are recorded. Rules for establishing records for
specific types of inspections are defined in Operating Procedures (OP-10:
Purchasing and Verification of Purchased Product) and Operating Procedure
(OP11: Monitoring and Measurement of Product). Filing and maintenance of
inspection records are regulated by Operating Procedure (OP18: Control of
Records).
Acceptance inspections are performed by Quality Control Inspectors.
The records indicate the person authorizing, Quality Assurance Manager for
final acceptance and release of the product for delivery to the customer.
8.3
Quality Manual
FO-2015-0
8.0
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Section : 8.0
Revision: 2
Page: 5 of 11
Signature
Signature
: Dedy Kurniadi
Quality Manual
FO-2015-0
8.0
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Section : 8.0
Revision: 2
Page: 6 of 11
Signature
Signature
: Dedy Kurniadi
Quality Manual
FO-2015-0
8.0
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Section : 8.0
Revision: 2
Page: 7 of 11
Signature
Signature
: Dedy Kurniadi
Detailed rules for nonconformity review, for making the disposition decision,
and for recording these activities are provided in Operating Procedure (OP
12: Control of Nonconforming Product).
When product nonconformity is detected by the customer after delivery or use
has started, the customer is instructed to return the product, or a part, on a
return authorization number issued by PIS Department.
Field reported nonconformance(s) are recorded in the Nonconformance
Report. The Quality Assurance Manager shall determine the cause of the
discrepancy, and provide corrective action to prevent recurrence of the same
nature. Field nonconformance(s) are reported during management review.
When product nonconformity is detected internally after delivery or use has
started, the customers are informed and instructed what to do with the product.
In situations when the nonconformity may create a safety or other hazard, the
product may be recalled. Only the President Director of the company is
authorized to make recall decisions.
Pipamas has established a documented Operating Procedure (OP12: Control
of Nonconforming Product) to define control of nonconforming product. This
procedure shall include the analysis and the requirements for identifying,
documenting and reporting incidents of all field nonconformities.
8.4
Analysis of Data
Pipamas shall establish control features for the identification and use of
techniques for the analysis of data, collects, compiles and analyzes information
and data required for evaluating the suitability and effectiveness of the quality
system and for identifying opportunities for continual improvement.
This data comes from a number of sources such as internal audits,
management reviews, product verification, and continual improvement activities.
Data and information recorded in quality records are compiled and analyzed
periodically to determine trends in the performance and effectiveness of the
quality system and to identify opportunities for improvement.
Quality Assurance is responsible for coordinating these activities, and for
reporting conclusions and trends to the executive management. This is
usually done within the framework of management reviews of the quality
Quality Manual
FO-2015-0
8.0
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Section : 8.0
Revision: 2
Page: 8 of 11
Signature
Signature
: Dedy Kurniadi
Quality Manual
FO-2015-0
8.0
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Section : 8.0
Revision: 2
Page: 9 of 11
Signature
Signature
: Dedy Kurniadi
Improvement
The improvement effort is driven by goals defined in the quality policy and
quality objectives. Improvement opportunities are identified by analyzing quality
performance data and information. Improvement projects are defined and
implemented through the system of corrective and preventive actions and
management review actions.
Causes of identified nonconformities are investigated and the requirements
for determining the causes of nonconformities shall be defined as Operating
Procedure (OP25: Corrective and Preventive Action), where appropriate,
corrective actions are implemented to ensure that nonconformities do not
recur. Preventive actions are implemented to eliminate the causes of potential
nonconformities. Corrective and preventive actions taken are recorded and
are followed up to ensure that they have been properly implemented and that
they are effective.
8.5.1
Continual improvement
Quality Manual
FO-2015-0
8.0
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Section : 8.0
Revision: 2
Page: 10 of 11
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: Dedy Kurniadi
The need for corrective action is determined on the basis of identified actual
nonconformities. Corrective action requests are typically triggered by such
events as a failed inspection, customer complaint and/or product return,
nonconforming delivery from a supplier, or a major quality system audit
finding.
Continual improvement actions are often defined as corrective and preventive
actions. Procedures (OP28: Continual Improvements), and Operating
procedure (OP27: Management Review), explain how the corrective and
preventive action system is used for facilitating continual improvement.
8.5.2
Corrective Action
Pipamas takes action to eliminate the causes of nonconformities in order to
prevent recurrence. Corrective actions are appropriate to the effects of the
nonconformities encountered. Pipamas has a documented procedure (OP25:
Corrective and Preventive Action) and (OP28: Continual Improvement) to
define requirements for:
Reviewing nonconformities (including customer complaints)
Determining causes of nonconformities,
Evaluating the need for action to ensure that nonconformities do not occur,
Determining and implementing action needed,
Record the results of action taken
Review of effectiveness of corrective action taken,
Supplier corrective action if it is determined they are responsible,
Specific actions where timely and/or effective corrective action is not
achieved.
Pipamas shall ensure that any corrective action is effective, and shall identify
response times for addressing corrective action. Ten (10) days are allowed for
response to any corrective action otherwise the Quality Manager to facilitate
obtaining a satisfactory response.
8.5.3
Preventive action
The need for preventive action is determined on the basis of information and
data regarding capability and performance of processes, product
nonconformity rates, post-production experience feedback, customer
complaints, and quality system audit findings. Such information and data are
collected and analyzed to detect unfavorable trends that, if not checked, will
increase the risk of nonconformities. The system for collecting and analyzing
quality performance information and data is defined in Section 8.4 of this
manual.
Quality Manual
FO-2015-0
8.0
MEASUREMENT, ANALYSIS
AND IMPROVEMENT
Section : 8.0
Revision: 2
Page: 11 of 11
Signature
Signature
: Dedy Kurniadi