ISO 9001:2000 General Requirements Production Support

Reviewer Checks

Reviewer Checks

Planning the Process Audit

Define key inputs and resources for each of the processes to
be reviewed. Use process documentation, flowcharts or
SIPOC diagrams to identify these.
Process
Key Inputs and Resources

Determine the processes/activities to be included in the scope

of the audit. The scope may be provided as part of an audit
schedule or plan, or it may need to be developed by the audit
program manager. List the process(es) below:
Processes
Document No.
Maintenance
Tooling Management
Calibration
Testing
Servicing
Consider the following information relating to the processes to
be examined.
Previous audit results related to the selected processes
Current process metrics relating to the selected processes
Significant corrective actions or complaints relating to the
selected processes
Auditee management
Other (list) _____________________________________

Based on your review, add, delete, or modify the questions

on this checklist to focus your evaluation and to incorporate
local requirements and inputs. Recognize that most of the
requirements that must be verified will be called out in local
procedures and instructions.
Corrective Actions and Current/Recent problems
List any problems, CARs, or items from previous audits that
should be evaluated or verified during this audit.
Problems noted for later examination:

Review the core process metrics relating to production support.

Metric
Recent Performance
Trend
1.
2.
3.
4.
5.
Objectives and/or targets to review:
1.

2.

2003 Joe Kausek & Associates

Maintenance Program
Interview the Director or Manager of
Maintenance. Ask him/her the following
questions:
What are the primary activities that make up
the maintenance program? Examples include
PM, predictive maintenance, maintenance
planning, spare part use and stocking,
maintenance improvement, and machinery
history.
List these in the space to the right. Note lack
of controls for any core maintenance
processes.

This items looks at the overall preventive maintenance program. Individual

process audits will evaluate maintenance scheduling and performance for
related process equipment. The focus of this review should be on the
centralized aspects of the maintenance program, such as how maintenance
requirements are initially set, the process for issuance and documentation of
work/repair orders, the program for predictive maintenance, identification
and performance in achieving maintenance objectives, and monitoring of the
overall maintenance programs performance.
Maintenance Activities

Method of Control

How are each of these activities controlled?

List these in the space to the right.
Are critical infrastructure components
(pumps, tanks, air compressors, forklifts, etc.)
included in the maintenance program?

How are maintenance requirements

identified? How are they documented and
communicated?

Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the specific
requirement violated.

Comments and Findings

Once established, how do we control the
accomplishment of maintenance
requirements?

How do we assess the performance of our

maintenance process?
Review the metrics. Ask to see action plans
for problem areas.

2003 Joe Kausek & Associates

Identify any maintenance procedures, work

instructions, and/or related guidelines (see
previous page). Verify through actual
observation that these instructions are being
followed. If possible, go to a maintenance job
and observe the conduct of maintenance.
Answer the following questions for each
process/activity observed:

Are the instructions complete and accurate?

Do they appear to be at the right level of
detail, considering task complexity and
worker training?
Ask maintenance personnel for their opinions
and recommendations on how the procedures
might be improved. These may become OFIs.

This item continues our evaluation of the maintenance program by examining

any local procedures or instructions governing specific tasks.
Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the specific
requirement violated.
Instructions/Procedures

Evaluated?

Do the workers appear competent both in

their familiarity with the procedures and with
the conduct of the work?
Competencies OK?
Worker 1:
Do the maintenance personnel have the
required competencies and training? Note the
names of several to check later.

Worker 2:
Worker 3:

Are maintenance activities properly

recorded? Are historical records of
maintenance actions maintained? Are
maintenance documents and records
controlled?
Calibration OK?
Device 1:
Device 2:
Are instruments used for adjustments and/or
alignment calibrated?

2003 Joe Kausek & Associates

Tooling Management
Discuss the following questions with owner
of the tooling management program.
What are the core activities associated with
tooling management?

How are these processes controlled (e.g.

procedures, outsourcing, training)?
Ask to see copies of any procedures,
instructions, service contracts and/or
competency matrices.

The questions in this section focus on tooling management. Some of these

questions may have been covered in other process-based audits. These
questions focus on the centralized tooling management program, rather than
on any specific tool or machine.
Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the specific
requirement violated.

Activities

Controls/Procedures

Evaluated?

How are these processes monitored?

Review the metrics presented. Look for
problem areas, bad trends, ect. Ensure added
attention is given to these areas during the
remainder of the audit.

Are actions underway to improve

performance where needed?
Metrics
Verify the following are included in the
tooling management program, as appropriate
to the level of tooling management employed:
Maintenance and repair facilities and
personnel
Tooling storage and recovery
Tooling setup
Change out programs for perishable tools
Documentation of tooling and tooling
design modifications
Tooling identification and status
Note these items are required by ISO/TS
16949, but not for ISO 9001. Even so, they
form the backbone of a robust tooling
management program.

Performance/Trend

1.

Good

Poor

2.

Good

Poor

3.

Good

Poor

Comments and Findings

Reference ISO 9001, 6.3 and 7.5.1

2003 Joe Kausek & Associates

Servicing
Ask the service manager or process owner to
walk you through the organizations servicing
activities using the following questions:
What kinds of servicing activities do we
perform?
List in the space to the right.

Who are the customers of these activities?

What are their expectations for our services?
How do we know?
List in the space to the right.

How do we measure these activities to ensure

they are meeting customer, as well as our
own expectations? How are these processes
performing?
Review the metrics, link them to customers
and expectations, and review performance.
During the remainder of the audit place more
attention on areas of weakness.

These questions apply to service operations, provided after sale of the

product to the customer. The intent of the requirements evaluated here is to
ensure that services provided off-site receive the same level of control and
care as do those activities we perform at our own facility.
Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the specific
requirement violated.
Activities

Customers

Controls/Procedures

Expectations

Evaluated?

Metrics

How is feedback from the customer

communicated back throughout the
organization?

How are these activities controlled?

The remainder of the audit should focus on
verification of the compliance and
performance to the activities listed above.
Interview process operators, verify training,
examine records, and in general verify
processes are effective. Pay particular
attention to problem areas as indicated by
metrics or manager feedback.

Reference ISO 90017.5.1

2003 Joe Kausek & Associates

Calibration/Lab Testing
Ask the laboratory manager or process owner
to walk you through the scope of laboratory
operations. Use the laboratory scope,
organization chart, and/or process flowchart
as applicable to get a feel for the operations
and testing performed.

The questions in this section focus on monitoring and measuring device

management and component testing. Some of these questions may have been
covered in other process-based audits. These questions focus on the
centralized calibration program, rather than on any specific measurement
device or test.
Customers

Expectations

Who are the customers for laboratory

services? What are their expectations?
List in space to the right
Which of our activities/processes support
these customers/expectations?
List in space to the right
How do we measure our performance in
performing these activities? Is performance
okay?
List in space to the right
What kinds of calibrations and/or tests are
performed in the laboratory? Is there a
laboratory scope?
Verify a laboratory scope exists the includes
all the relevant tests and calibrations.

Processes

Metrics

Performance

1.

Good

Poor

2.

Good

Poor

3.

Good

Poor

Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the specific
requirement violated.

How are calibration frequencies determined?

Verify the basis (tech manual, mnfr.
recommendation, etc.)

How is measurement uncertainty determined?

List standards evaluated below.

Standard Set No.

2003 Joe Kausek & Associates

Calibrated?

Properly Controlled?

Yes

No

Yes

No

Yes

No

Yes

No

Review the control and verification of

laboratory standards. Are they periodically
checked against higher level standards? Are
there records? Are they reserved for use in the
lab?

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

List occurrences where equipment was found to be out of calibration when

received for calibration.
Are standard/industry methods used for
testing and calibrations?
Where available, industry or other stnd
methods should be used (e.g. ASTM, ASTD,
etc.). If not, the basis for the cal/test should
be documented.

Are laboratory environmental conditions

defined? Are they monitored? How are they
controlled?

Item/Device

Cal. Cert.

Evaluation Performed?
Yes

No

Yes

No

Yes

No

Yes

No

Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the specific
requirement violated.

What actions are taken when calibration

reports/results indicate that equipment was
out of calibration when received?
Thumb through the calibration records to
identify instances where the device was
received OOC or damaged. Verify that a
analysis of impact on product inspected with
the device was conducted.

Reference ISO 90017.6

2003 Joe Kausek & Associates