Introduction:
To
achieve sustained success in an ever-changing and uncertain environment, it is
necessary for the organization to regularly monitor, measure, analyse and
review its performance (ISO 9004:2009). The organization shall continually
improve the effectiveness of the quality management system (ISO 9001:2008).
Measurement,
Analysis and Improvement emphasizes on the control and continual improvement of
product quality and quality management system. ISO 9004:2009 explains the
requirement of measurement and analysis as, ‘Top management should assess
progress in achieving planned results against the mission, vision, policies,
strategies and objectives, at all levels and in all relevant processes and
functions in the organization. A measurement and analysis process should be
used to monitor this progress, to gather and provide the information necessary
for performance evaluation and effective decision making. The selection of
appropriate key performance indicators (KPI) and monitoring methodology is critical
for success of measurement and analysis process’.
Measurement and analysis of a process and product will result
in data which when analyzed forms an input for continual improvement of QMS and
product quality. The organization shall identify the key performance indicators
(of process and product quality) and device a methods for collecting
information regarding key performance indicators. Typical examples of these
methods given in ISO 9004:2009 are:
Risk
assessment and risk control,
Interviews, questionnaires
and survey on customer and other interested parties’ satisfaction,
Benchmarking
Performance
reviews, including suppliers and partners, and
Monitoring and
recording of process variables and product characteristics.
| 8 | MEASUREMENT, ANALYSIS & IMPROVEMENT |
| 8.1 | GENERAL |
8.0 Measurement, analysis and improvement
8.1 General
The organization has
defined, planned, and implemented the monitoring, measurement, analysis and
improvement processes needed to assure product and QMS conformity and achieve
continual improvement of quality management system.
Product: Measurement and monitoring activities to ensure and verify
product conformity are defined in specifications, sampling and testing plan
& procedures, work orders, drawing and layouts and process control
procedures.
Sampling: Sampling plan for inspection, testing and other product
acceptance activities are documented. Sampling plans are reviewed and approved
by quality department to ensure that they are based on valid statistical
rational and are defined appropriately. These plans are reviewed when
nonconformities are identified and such reevaluation is carried out within the
framework of the pertinent corrective action.
Quality management System: The conformity and effectiveness of the quality system are
monitored by internal audits, non-conformance reporting, and Corrective and
Preventive actions and by measuring quality performance and customer
satisfaction. The results of these activities are discussed in management
review meetings and are used to identify opportunities for improvement.
Activities related to internal audits and to measuring customer feedback and
quality performance are defined (Section/Clause 8.2).
Statistical Techniques: Instructions and procedures for implementing and controlling
the application of statistical techniques including control charts, analysis
using histograms, Pareto, cause and effect diagrams and other statistical tools
are available.
Statistical techniques are
used for establishing, controlling, and verifying process capability and
product characteristic. They may be used for:
Setup of process equipment/Design (performance/capability
measurement, reliability, maintainability, safety)
Design
of experiments (DOE)
Validation
and/or testing of process/method
Control
of process stability and performance (SPC)
Establishment
of sampling plans for inspection and testing,
Evaluation
of measurement system; and
Analysis
of quality performance and other company-level data.
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