9 Performance Evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General
See ISO 9001:2015 requirements

9.1.1.1 Monitoring and measurement of manufacturing processes
The organization shall perform process studies on all new manufacturing (including assembly or
sequencing) processes to verify process capability and to provide additional input for process control,
including those for special characteristics.

NOTE For some manufacturing processes, it may not be possible to demonstrate product compliance through process capability. For those processes, alternate methods such as batch conformance to specification may be used

The organization shall maintain manufacturing process capability or performance results as specified
by the customer’s part approval process requirements. The organization shall verify that the process
flow diagram, PFMEA, and control plan are implemented, including adherence to the following:

a) measurement techniques;
b) sampling plans;
c) acceptance criteria;
d) records of actual measurement values and / or test results for variable data;
e) reaction plans and escalation process when acceptance criteria are not met.
Significant process events, such as tool change or machine repair, shall be recorded and retained as
documented information.

The organization shall initiate a reaction plan indicated on the control plan and evaluated for impact
on compliance to specifications for characteristics that are either not statistically capable or are
unstable. These reaction plans shall include containment of product and 100 percent inspection, as
appropriate. A corrective action plan shall be developed and implemented by the organization
indicating specific actions, timing, and assigned responsibilities to ensure that the process becomes
stable and statistically capable. The plans shall be reviewed with and approved by the customer, when
required.

The organization shall maintain records of effective dates of process changes.

9.1.1.2 Identification of statistical tools
The organization shall determine the appropriate use of statistical tools. The organization shall verify
that appropriate statistical tools are included as part of the advanced product quality planning (or
equivalent) process and included in the design risk analysis (such as DFMEA) (where applicable), the
process risk analysis (such as PFMEA), and the control plan.

9.1.1.3 Application of statistical concepts
Statistical concepts, such as variation, control (stability), process capability, and the consequences of
over-adjustment, shall be understood and used by employees involved in the collection, analysis, and
management of statistical data.

9.1.2 Customer satisfaction
See ISO 9001:2015 requirements

9.1.2.1 Customer satisfaction – supplemental
Customer satisfaction with the organization shall be monitored through continual evaluation of
internal and external performance indicators to ensure compliance to the product and process
specifications and other customer requirements.

Performance indicators shall be based on objective evidence and include but not be limited to the
following:
a) delivered part quality performance;
b) customer disruptions;
c) field returns, recalls, and warranty (where applicable);
d) delivery schedule performance (including incidents of premium freight);
e) customer notifications related to quality or delivery issues, including special status.

The organization shall monitor the performance of manufacturing processes to demonstrate
compliance with customer requirements for product quality and process efficiency. The monitoring
shall include the review of customer performance data including online customer portals and
customer scorecards, where provided.

9.1.3 Analysis and evaluation
See ISO 9001:2015 requirements

9.1.3.1 Prioritization
Trends in quality and operational performance shall be compared with progress toward objectives
and lead to action to support prioritization of actions for improving customer satisfaction.

9.2 Internal audit

9.2.1 and 9.2.2
See ISO 9001:2015 requirements

9.2.2.1 Internal audit program
The organization shall have a documented internal audit process. The process shall include the
development and implementation of an internal audit programme that covers the entire quality
management system including quality management system audits, manufacturing process audits, and
product audits.

The audit programme shall be prioritized based upon risk, internal and external performance trends,
and criticality of the process(es).

Where the organization is responsible for software development, the organization shall include
software development capability assessments in their internal audit programme.

The frequency of audits shall be reviewed and, where appropriate, adjusted based on occurrence of
process changes, internal and external nonconformities, and/or customer complaints. The
effectiveness of the audit programme shall be reviewed as a part of management review.

9.2.2.2 Quality management system audit
The organization shall audit all quality management system processes over each three-year calendar
period, according to an annual programme, using the process approach to verify compliance with this

Automotive QMS Standard. Integrated with these audits, the organization shall sample customer-
specific quality management system requirements for effective implementation

9.2.2.3 Manufacturing Process Audit
The organization shall audit all manufacturing processes over each three-year calendar period to
determine their effectiveness and efficiency using customer-specific required approaches for process
audits. Where not defined by the customer, the organization shall determine the approach to be used.
Within each individual audit plan, each manufacturing process shall be audited on all shifts where it
occurs, including the appropriate sampling of the shift handover.

The manufacturing process audit shall include an audit of the effective implementation of the process
risk analysis (such as PFMEA), control plan, and associated documents.

9.2.2.4 Product audit
The organization shall audit products using customer-specific required approaches at appropriate
stages of production and delivery to verify conformity to specified requirements. Where not defined
by the customer, the organization shall define the approach to be used.

9.3 Management review

9.3.1 General
See ISO 9001:2015 requirements

9.3.1.1 Quality management system performance
Management review shall be conducted at least annually. The frequency of management review(s)
shall be increased based on risk to compliance with customer requirements resulting from internal or
external changes impacting the quality management system and performance-related issues.

9.3.2 Management review inputs
See ISO 9001:2015 requirements

9.3.2.1 Management Review Input – Supplemental
Input to management review shall include.

a) cost of poor quality (cost of internal and external non-conformance);
b) measures of process effectiveness;
c) measures of process efficiency;
d) product conformance;
e) assessments of manufacturing feasibility made for changes to existing operations and for new
facilities or new product (see Section 7.1.3.1);
f) customer satisfaction (see ISO 9001, Section 9.1.2);
g) review of performance against maintenance objectives;
h) warranty performance (where applicable);
i) review of customer scorecards (where applicable);
j) identification of potential field failures identified through risk analysis (such as FMEA);
k) actual field failures and their impact on safety or the environment.

9.3.3 Management review outputs
See ISO 9001:2015 requirements

9.3.3.1 Management Review Output - Supplement
Top management shall document and implement an action plan when customer performance targets
are not met.