Resources and System Support

This checklist is for evaluation of the processes used to provide essential inputs into the customer-oriented product
realization processes. It includes human, technical and system resources not included elsewhere in the Quality Planning,
Production Process, Management Responsibility or Key Support Process checklists. Note that some of the requirements
for certain processes (such as training or document control) are verified during other process-based audits. This checklist
includes the centrally-managed components of those processes.

Resources and System Support

Standard Requirements Reviewer Checks

Planning the Audit

Determine the Resource and System Support Check the processes to be included:
processes to be included within the scope of
the audit. Each process should be reviewed at Resource/System Support Process Procedure
least once during each audit cycle, and after
problems, issues or concerns relating to that
process arise. Human Resources (inc. training)      
Document & Record Control      
Purchasing      
Maintenance      
Tooling Management      
Servicing      
Calibration/Lab Testing      
Internal Audit Program      
Corrective & Preventive Action      

Gather and review the information sources
listed below to the extent practical. Some of
these may be provided during the audit. To
the extent the auditor can review these prior
to the audit, the more comfortable the auditor
will be and the more deeply the auditor will
be able to probe.
During the audit use these items to gauge
ongoing support in maintaining and
improving the QMS.
Check items to review/reviewed below. Also list areas to examine in more
detail during the interviews.
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
Items/Issues/Concerns to follow-up on during audit:
1.
2.

3.

4.

 2003 Joe Kausek & Associates 1

Human Resources and Competencies
Identification of Core Processes
What are the primary services you provide to
your customers? This question is to find out
if key support processes like staffing and
employee development are considered as part
of the QMS.
List primary services below:
Start the audit by interviewing the Director/Manager of HR. The general
structure of the interview will be:
1) Who are our customers, and what are our core processes
2) How do we control them, how do we measure them
3) What objectives have been established and are they aligned with the
commitments of the Quality Policy and our Strategic Plan
4) How are we performing
5) What are we doing to improve performance
6) How do we communicate performance

Manager _______________________________________________

Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Which of these services have the potential to Best Practice (BP). Detail below. Be specific.
impact our external customers?
Nonconformity (NC). Provide details below. Reference the specific
requirement violated.

Key HR Services Procedures/Process for Control

What processes have we established to 1.

control these services? The auditor is
examining whether key support processes
that impact the QMS are controlled. 2.

3.

4.
How do we measure our performance in
providing these services? Review any 5.
performance metrics.

HR Metrics Performance Action if Poor?

1. ________________________ Good Poor Yes No

Are we actively improving any of these 2. ________________________ Good Poor Yes No

processes (corrective action, CI, objectives)?
Focus on poor performing processes. 3. ________________________ Good Poor Yes No

4. ________________________ Good Poor Yes No

Reference ISO/TS 16949 6.2

 2003 Joe Kausek & Associates 2

Identification of Competencies and
Training Needs
Have competencies been identified for all
functions within the organization? Evaluate
the reasonability for any functions not
included (must not affect quality of products
or services)
List those not included below:
How were/are competency requirements
identified? Are competencies directly linked
to activities performed in the process?
Continue the audit by interviewing those responsible for the training
program. The availability, use and achievement of competencies and training
should be evaluated as an ongoing part of each process audit, therefore focus
on the process by which competencies are initially identified and developed.
Manager _______________________________________________
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.
Function/Department Competencies Competencies
Reviewed Identified? Maintained?

1. _______________________ Good Poor Yes No

2. _______________________ Good Poor Yes No

Is the process applied consistently across
functions/Departments? Are competency
matrices being maintained? Verify 3. _______________________ Good Poor Yes No
competency requirements and attainments are
being updated. 4. _______________________ Good Poor Yes No

5. _______________________ Good Poor Yes No

6. _______________________ Good Poor Yes No

How do we measure the effectiveness of our 7. _______________________ Good Poor Yes No

training and actions? List metrics on
previous page in right hand column. 8. _______________________ Good Poor Yes No

Methods for Promoting Quality Awareness

How is quality awareness promoted? Is it a

part of orientation training? Is HR involved
at all?

Reference ISO/TS 16949 6.2

 2003 Joe Kausek & Associates 3

Document & Record Control
Ask to see the procedure. Ask the owner of
the process to walk you through the process
(follow along if you have a procedure). Focus
on the centralized aspects of document and
data control (actual control of documents will
be verified during process audits) During the
discussion verify evidence of:
Is a system of locating and controlling master
documents, including the Master List (or
equiv.) in place?
This interview focuses on the centralized aspects of document and record
control. Alternatively, individual process audits can explore many of these
areas in addition to the physical control of specific documents. This is
especially true when document control is decentralized among different
departments or work centers.
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.

Are electronic documents properly

Comments and Findings
controlled? Are they accessible (i.e. people
know the file path)? Are master documents
protected against unauthorized modification?

Is control of external documents as to their

location and distribution part of the
document control process?

Are responsibilities for review, approval

established?

Are documents periodically evaluated for

adequacy? How (e.g. annually, or during
internal audits)? Is there evidence that
documents are being improved through these
reviews?

Are all other requirements of the procedure

being followed?

Measures of Effectiveness Performance Action if Poor?

1. ________________________ Good Poor Yes No

Is this process reviewed for effectiveness? 2. ________________________ Good Poor Yes No

How?

Reference ISO/TS 16949 4.2.4

 2003 Joe Kausek & Associates 4

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?
List these in the space to the right.
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.

How are each of these activities controlled?

Maintenance Activities Method of Control
List these in the space to the right.

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.
Once established, how do we control the Nonconformity (NC). Provide details below. Reference the specific
accomplishment of maintenance requirement violated.
requirements?
Examples of Predictive Maintenance
Example Where Used
1.
Is predictive maintenance a part of our
program? Where? How often? 2.

3.

4.
How do we assess the performance of our
maintenance process?
Review the metrics. Ask to see action plans Maintenance Measures Performance Action if Poor?
for problem areas.
1. ________________________ Good Poor Yes No

2. ________________________ Good Poor Yes No

Have maintenance objectives been set? Are

Maintenance Objectives Performance Action if Poor?
they being monitored? What is our
performance thus far?
1. ________________________ Good Poor Yes No

2. ________________________ Good Poor Yes No

Reference ISO/TS 16949 7.5.1.4

 2003 Joe Kausek & Associates 5

Identify several maintenance procedures, This item continues our evaluation of the maintenance program by examining
work instructions, and/or related guidelines any local procedures or instructions governing specific tasks.
(see previous page). Verify through actual
observation (if possible) that these Overall evaluation:
instructions are being followed. If possible,
Conforms. No deficiencies identified.
go to a maintenance job and observe the
conduct of maintenance. Answer the Opportunity for improvement (OFI). Detail below.
following questions for each process/activity Best Practice (BP). Detail below. Be specific.
observed: Nonconformity (NC). Provide details below. Reference the specific
requirement violated.
Are the instructions complete and accurate?
Do they appear to be at the right level of Instructions/Procedures Performed Okay?
detail, considering task complexity and
worker training? Yes No
Ask maintenance personnel for their opinions
and recommendations on how the procedures
Yes No
might be improved. These may become OFIs.

Yes No

Competencies Okay?
Do the workers appear competent both in
their familiarity with the procedures and with Worker 1:
the conduct of the work?
Worker 2:

Worker 3:
Do the maintenance personnel have the
required competencies and training? Note the Calibration Okay?
names of several to check later. Device 1:

Device 2:

Are maintenance activities properly

recorded? Are historical records of
maintenance actions maintained? Are
maintenance documents and records
controlled?

Are instruments used for adjustments and/or

alignment calibrated?

Reference ISO/TS 16949 7.5.1.4

 2003 Joe Kausek & Associates 6

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.

How are these processes monitored? Are

actions taken when performance is poor? Activities Controls/Procedures
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.

How is the inventory of tooling controlled? Is

there a system to stock necessary Metrics Performance/Trend
consumables and spare parts prior to their
depletion? 1. Good Poor

Is there a process to verify/qualify fixtures 2. Good Poor

and tooling such as molds prior to use? Are
these items included in a maintenance
program? 3. Good Poor

Are actions underway to improve Does the program include:

performance where needed? Maintenance of tooling Yes No
Repair and recovery of tooling Yes No
Verify the following are included in the Adequate facilities Yes No
tooling management program, as appropriate Trained/competent personnel Yes No
to the level of tooling management employed. Tooling storage including inventory control Yes No
List results in the right hand column. Tooling setup, including setup instructions Yes No
Maintenance and repair facilities and Change out programs for perishable tools Yes No
personnel
Tooling design control Yes No
Tooling storage and recovery
Visual ID of customer-owned tooling Yes No
Tooling setup
Change out programs for perishable tools
Documentation of tooling and tooling
design modifications
Tooling identification and status

Reference ISO/TS 16949 7.5.1.5

 2003 Joe Kausek & Associates 7

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.
Who are the customers for laboratory
services? What are their expectations?
Depending on the types of services performed
by the lab, the list of internal/external
customers could be long. List in space to the
right.
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.
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.

Customers Expectations
Which of our activities/processes support
these customers/expectations?
List in space to the right

Processes Metrics Performance

How do we measure our performance in
performing these activities? Is performance 1. Good Poor
okay? List in space to the right
2. Good Poor

What kinds of calibrations and/or tests are 3. Good Poor

performed in the laboratory? Is there a
laboratory scope?
Verify a laboratory scope exists that includes
all the relevant tests and calibrations.

How are calibration frequencies determined?

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

 2003 Joe Kausek & Associates 8

 List standards evaluated below.
Review the control and verification of
laboratory standards. Are they periodically Standard Set No. Calibrated? Properly Controlled?
checked against higher level standards? Are
there records? Are they reserved for use in the
Yes No Yes No
lab?

Yes No Yes No

Yes No Yes No

Yes No Yes No
Are standard/industry methods used for
testing and calibrations?
Where available, industry or other stnd Yes No Yes No
methods should be used (e.g. ASTM, ASTD,
etc.). If not, the basis for the cal/test should List occurrences where equipment was found to be out of calibration when
be documented. received for calibration.

Item/Device Cal. Cert. Evaluation Performed?

Yes No

Are laboratory environmental conditions Yes No

defined? Are they monitored? How are they
controlled? Yes No

Yes No

Overall evaluation:
Conforms. No deficiencies identified.
Opportunity for improvement (OFI). Detail below.
Best Practice (BP). Detail below. Be specific.
What actions are taken when calibration Nonconformity (NC). Provide details below. Reference the specific
reports/results indicate that equipment was requirement violated.
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.

 2003 Joe Kausek & Associates 9

Reference ISO/TS 16949 7.6

 2003 Joe Kausek & Associates 10

Purchasing
The auditor can evaluate the procurement Use a strategy to select a sampling of suppliers to evaluate the process. Do
process using three basic strategies: not forget to include some key service providers. List the selected suppliers
1) Pick one or more parts currently in below:
production, pull the BOM(s) for the
component(s), and then use the suppliers Supplier Product/Service Provided Criteria Applied?
of the materials on the BOM to serve as
your sample set.
___________________ ________________________ Yes No
2) Ask to see a listing of suppliers, and
then select representative suppliers from
the list. ___________________ ________________________ Yes No
3) Use a combination of both 1 and 2
above. ___________________ ________________________ Yes No
Using your sample set, and a copy of the
documented procedure (if one exists – it is ___________________ ________________________ Yes No
not mandatory) ask the purchasing
manager/agent to walk you through the ___________________ ________________________ Yes No
following questions relating to the purchasing
process.
___________________ ________________________ Yes No
What are our criteria for evaluating and
selecting subcontractors? Is it reasonable
given the nature and importance of the Overall evaluation:
products/services provided? Were the criteria Conforms. No deficiencies identified.
applied to the sample set? Are there records Opportunity for improvement (OFI). Detail below.
of evaluations? Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the specific
requirement violated.

Supplier ISO 9001:2000

or TS Certified?

How can you tell when a supplier is customer ___________________________________________ Yes No

mandated? Are customer-mandated/approved
suppliers used where required?
___________________________________________ Yes No

___________________________________________ Yes No

___________________________________________ Yes No

How are suppliers developed? Are suppliers

registered to ISO 9001:2000? Are they being ___________________________________________ Yes No
encouraged/supported in developing systems
compliant to ISO/TS 16949:2002? ___________________________________________ Yes No

___________________________________________ Yes No

___________________________________________ Yes No

 2003 Joe Kausek & Associates 11

Reference ISO/TS 16949 7.4 Overall evaluation:
Review copies of Purchase Orders issued to Conforms. No deficiencies identified.
the selected suppliers. Verify the adequacy of Opportunity for improvement (OFI). Detail below.
the communicated requirements. Best Practice (BP). Detail below. Be specific.
Nonconformity (NC). Provide details below. Reference the specific
Does the information contained in the requirement violated.
purchase adequately describe the product or
service being purchased? Does it include
Record POs reviewed below.
adequate technical information (custom
parts, features or services)? Are regulatory
requirements included, as appropriate? PO Number Info. Adequate? Reviewed/Verified?

Yes No Yes No

Are there any special approval requirements Yes No Yes No

for the product or service (e.g. must our
organization approve personnel, equipment, Yes No Yes No
methods, or QMS)? How would the buyer
know if there were any?
Yes No Yes No

Yes No Yes No
How is the adequacy of information ensured
prior to PO release? Who verifies the
adequacy of information? Ask him/her what Yes No Yes No
they review for (ensure they review the
adequacy of information, not just that the Summarize performance metrics/trends below.
supplier is approved).
Metric Trend Action?

Good Poor Yes No

How are suppliers monitored? Is the
information provided back to the suppliers to Good Poor Yes No
promote improvement? Are criteria for re-
evaluation established? Are results of re-
evaluation recorded? Good Poor Yes No

Good Poor Yes No

Is the purchasing process effective? Look at

trends in quality and delivery performance. Is
action being taken for suppliers with poor
performance? Has action been effective?

 2003 Joe Kausek & Associates 12

Reference ISO/TS 16949 7.4

 2003 Joe Kausek & Associates 13