9001 Audit Checklist - Quality Planning and Design

ISO 9001:2000 General Requirements Order Generation, Quality Planning and Design
Reviewer Checks
Reviewer Checks
Planning the Process Audit

Sketch the rough process flow, including key inputs
and primary outputs. Use a separate sheet if needed.
Inputs
Process
Outputs
Based on your review, add, delete, or modify the

questions on this checklist to focus your evaluation
and to incorporate local requirements and inputs.
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:
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.
Consider the following information relating to the processes to

be examined.
Previous audit results of the design process
Current process metrics relating to sales or design
Any open or recent corrective actions, complaints relating
to design and development
History of returned product, returned product analysis, and
customer feedback (metrics)
Quality objectives relating to sales, design, development or
engineering
Recent lessons learned
Auditee management
Other (list) _____________________________________
Review the core process metrics relating to sales, marketing

and/or engineering.
Metric
Recent Performance
Trend
1.
2.
3.
Objectives and/or targets to review:
1.
2.
2004 Joe Kausek & Associates
General Process Audit Guidance

Using the organizations procedures, have the
auditee walk you through the process, verifying the
requirements listed below as you come to them. Pay
particular attention to product and information
transitioning from one activity to the next.
Start with the Account Manager/salesperson and evaluate the

order generation process. Then move to the Lead Project
Engineer to evaluated the design/quality planning process.
Follow along with the procedures, verifying compliance, as
they walk you through the steps, asking additional questions
from the checklists below.
Part One Order Generation (Sales or Account Manager)

Determining Product Requirements
Do we have a procedure for order generation,
contract review and/or order entry? Ask to see the
procedures. Note the numbers and revision date for
later confirmation of document control.
Can I see a list of active contracts? The auditor will
need to pick one or more objects to use to test the
system. Pick more recent orders/contracts if
possible. Pick one or more that included design if
you are evaluating design control also. You will use
these through the rest of the evaluation. You may
want to select orders for several account managers.
Can you walk me through our process for
generating an order, from quotation to order entry?
Have the auditee walk you through the order
generation process, verifying the information below
as you go. During the interview, have them show
you records of any required reviews using your test
objects. Also have them show you how data entries
are made, using an actual order if available.
Procedure
Contract/Part No.
No.
Rev. Date
Dated
Customer
1.
2.
3.
Overall evaluation:
Did not check.
Did not apply.
Conforms. No deficiencies identified.
Opportunity for improvement. Detail below.
Best Practice. Detail below. Be specific.
Nonconformity. Provide details below.
Is there a process for identifying customer specified

product requirements? Pay attention to who is
involved in the review. Review the contracts/orders
selected as test objects and note some of the key
customer requirements on the next page.
Is there a process for identifying product
requirements not specified by the customer but
which we know are needed? How is this done? Ask
for examples. List any on the next page.
Note mandatory customer information required by
local procedures. Is the required information
consistently obtained and documented?
Are all/any regulatory requirements identified?
Are customer-specific requirements reviewed? Note
who reviewed the requirements on the next page.
Reference
ISO 9001 7.2
List customer specified and non-specified requirements identified during the review of the contracts or orders selected
as objects below. Include specifications, drawings and other referenced documents called out in the contract or order.
During the review of quality planning and design you will want to verify availability of the these documents and
fulfillment of these requirements, at which time the questions can be answered.
Contract/Part No. ____________________________
Requirement/Specification/Drawing
Reviewed? By Who(function)?
Evidence Met?
1.
Yes
No ______________
Yes
No
Yes
No
2.
Yes
No ______________
Yes
No
Yes
No
3.
Yes
No ______________
Yes
No
Yes
No
4.
Yes
No ______________
Yes
No
Yes
No
5.
Yes
No ______________
Yes
No
Yes
No
Yes
No
Yes
No
6.
Yes
No ______________
Contract/Part No. ____________________________
Have?
Evidence Met?
1.
Yes
No ______________
Yes
No
Yes
No
2.
Yes
No ______________
Yes
No
Yes
No
3.
Yes
No ______________
Yes
No
Yes
No
4.
Yes
No ______________
Yes
No
Yes
No
5.
Yes
No ______________
Yes
No
Yes
No
Yes
No
Yes
No
6.
Yes
No ______________
Contract/Part No. ____________________________
Have?
Have?
Evidence Met?
1.
Yes
No ______________
Yes
No
Yes
No
2.
Yes
No ______________
Yes
No
Yes
No
3.
Yes
No ______________
Yes
No
Yes
No
4.
Yes
No ______________
Yes
No
Yes
No
5.
Yes
No ______________
Yes
No
Yes
No
6.
Yes
No ______________
Yes
No
Yes
No
Are the product requirements noted above reviewed

prior to committing to supply the product? Is it
Contract/Part No.
Requirements
Documented?
Requirements
Reviewed?
feasible to manufacture, without undue risk?
If verbal orders are received by the organization, are

verbal orders confirmed prior to committing to
provide product?
Is there a process in place to control contract

changes? Are they being reviewed prior to
implementation? Is it being followed? Review
several contract amendments and indicate the major
thrust of the change in the column to right. Verify
these were communicated and implemented in the
later stages of the audit.
Training and Awareness

Is the auditee knowledgeable of the process? Does
he or she appear competent? Note their name to
verify training records later.
Is the auditee aware of their specific roles and
responsibilities, and the limits to their authority, in
generating and handling customer contracts and
orders. Pay particular attention to reviews and
approvals.
Is the auditee aware of the quality policy, and how it
relates to their job?
Is there evidence that the process was effective in

identifying customer requirements and needs?
Review information relating to customer
complaints, concerns and returns to evaluate if the
sales/quality planning team did a good job of
identifying customer needs and wants prior to
launching the product. A high number of
engineering change requests issued shortly after
launch may be an indicator that insufficient time is
being spent understanding customer needs.
1.
Yes
No
Yes
No
2.
Yes
No
Yes
No
3.
Yes
No
Yes
No
Contract Amendment
Reviewed?
Implemented?
1.
Yes
No
Yes
No
2.
Yes
No
Yes
No
3.
Yes
No
Yes
No
4.
Yes
No
Yes
No
Interviewee Name
Training?
Awareness?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Indicators of Effectiveness
Indicator/Metric
Value
Trend
1. ___________________________ ________ _________

2. ___________________________ ________ _________
Overall evaluation:
Did not check.
Did not apply.
Part Two Quality Planning and Design (Lead Project Engineer)

Design Planning/Quality Planning

Design Planning
Do we have a procedure for design control? Ask to
see the procedures. Note the numbers and revision
date for later confirmation of document control.
Procedure
Can I see a list of projects still under development?

If the objects selected earlier did not include any
products that are still under development, then select
one or two additional objects that are. You will need
some products that are in a later stage of
development to verify that design activities are
being conducted as required by local procedures.
1. _____________________________
Can you walk me through our process for designing

a new product?
Have the auditee walk you through the design
process, verifying the information below as you go.
During the interview, have them show you records
of any required reviews using your test objects you
previously selected. Use the worksheets on pages 6
8 to aid in your review of design control.
No.
Rev. Date
Test objects selected still under development
2. _____________________________
Overall evaluation:
Did not check.
Did not apply.
Is a process in place to plan the design and

development? Does it include:
Designation of the design stages?
Designation of the verification, reviews and
validations required?
Responsibilities and authorities for design
activities/actions, including identification of key
interfaces?
Monitoring/tracking/updating the design
documentation/plan as the design proceeds?
Is there evidence that the plan was followed during
the project? Use the worksheets on the next several
pages to verify the design process is being or was
followed and requirements met.
Reference
ISO 9001 7.3.1
Design Planning and Verification Worksheet

Using the design and development plan generated for the products selected that are still under development, answer the
following questions.
Contract/Part No. ____________________________
Design Plans
Verifications
Responsibilities
Available?
Identified on Plans?
Identified
Yes
No
Yes
No
Yes
No
Timing
Identified?
Yes
No
Plan
Updated?
Yes
No
Verifications
Performed?
Yes
No
Customer Requirements Verify that customer requirements identified during the order generation phase of the
audit, listed on page 3, are available and were incorporated into the design during your discussion with the lead project
engineer. Indicate results of this review on page 3. The following sections focus on additional detailed design
requirements identified during your review of these drawings, specifications or functional requirements.
Design
Requirement
Design Inputs
Identified?
Design Inputs
Documented?
Design Input
Reviewed?
Requirements
Met?
1.
Yes
No
Yes
No
Yes
No
Yes
No
2.
Yes
No
Yes
No
Yes
No
Yes
No
3.
Yes
No
Yes
No
Yes
No
Yes
No
4.
Yes
No
Yes
No
Yes
No
Yes
No
Design Reviews
Held?
Documented?
Issued Addressed?
1.
Yes
No
Yes
No
Yes
No
2.
Yes
No
Yes
No
Yes
No
3.
Yes
No
Yes
No
Yes
No
Design
Output (Drawings, specifications, BOM, ect.)
Design Outputs
Reviewed?
Acceptance Criteria
Identified?
1.
Yes
No
Yes
No
2.
Yes
No
Yes
No
3.
Yes
No
Yes
No
4.
Yes
No
Yes
No
Yes
No
Performance
Did the Project Launch On-time or Is it On-track
The following questions are only applicable to projects that have been launched.
Did the project meet its target cost?
Yes
No Did the project meet its sales goals?
Yes
No
Were Lessons Learned developed for this project?
Yes
No
Is there evidence of an unusually high number of Engineering Change Requests for this product?
Yes
No
Contract/Part No. ____________________________
Design Plans
Verifications
Responsibilities
Available?
Identified
Yes
No
Yes
No
Yes
No
Timing
Identified?
Yes
No
Plan
Updated?
Yes
No
Verifications
Performed?
Yes
No
Design
Requirement
Design Inputs
Identified?
Design Inputs
Documented?
Design Input
Reviewed?
Requirements
Met?
1.
Yes
No
Yes
No
Yes
No
Yes
No
2.
Yes
No
Yes
No
Yes
No
Yes
No
3.
Yes
No
Yes
No
Yes
No
Yes
No
4.
Yes
No
Yes
No
Yes
No
Yes
No
Design Reviews
Held?
Documented?
Issued Addressed?
1.
Yes
No
Yes
No
Yes
No
2.
Yes
No
Yes
No
Yes
No
3.
Yes
No
Yes
No
Yes
No
Design
Design Outputs
Reviewed?
Acceptance Criteria
Identified?
1.
Yes
No
Yes
No
2.
Yes
No
Yes
No
3.
Yes
No
Yes
No
4.
Yes
No
Yes
No
Yes
No
Performance
Yes
Yes
No
Yes
No
Yes
No
Contract/Part No. ____________________________

Design Plans
Verifications
Responsibilities
Available?
Identified
Yes
No
Yes
No
Yes
No
Timing
Identified?
Yes
No
Plan
Updated?
Yes
No
Verifications
Performed?
Yes
No
Design
Requirement
Design Inputs
Identified?
Design Inputs
Documented?
Design Input
Reviewed?
Requirements
Met?
1.
Yes
No
Yes
No
Yes
No
Yes
No
2.
Yes
No
Yes
No
Yes
No
Yes
No
3.
Yes
No
Yes
No
Yes
No
Yes
No
4.
Yes
No
Yes
No
Yes
No
Yes
No
Design Reviews
Held?
Documented?
Issued Addressed?
1.
Yes
No
Yes
No
Yes
No
2.
Yes
No
Yes
No
Yes
No
3.
Yes
No
Yes
No
Yes
No
Design
Design Outputs
Reviewed?
Acceptance Criteria
Identified?
1.
Yes
No
Yes
No
2.
Yes
No
Yes
No
3.
Yes
No
Yes
No
4.
Yes
No
Yes
No
Yes
No
Performance
Yes
Yes
No
Yes
No
Yes
Design Inputs
Are product design requirements identified and
documented? Do they include:
No
The auditor should verify that the customer requirements

noted during the earlier contract reviews have been reviewed
and incorporated into the design. Record the results of your
evaluation on pages 3 and 6 8.
Functional and performance requirements? Verify

availability of drawings, specification, etc. listed on
page 3.
Regulatory requirements?
Other (e.g. company specified) requirements
essential to the product (from page 3)?
Overall evaluation:
Did not check.
Did not apply.
List key requirements and indicate the results of

your review on pages 6 - 8.
Is there evidence that lessons learned from previous,

similar designs, along with customer complaints,
field returns, etc. were reviewed for applicability?
Include product and process related information.
Reference
ISO 9001 7.3.2
Design Outputs
Is there evidence that the design outputs were
reviewed prior to release? Record the results of your
review on pages 6 8.
Does design output contain adequate information

for purchasing and production?
This section verifies that the design outputs (specifications,

drawings, material lists, etc.) contain the required information
and were reviewed prior to their release.
Overall evaluation:
Did not check.
Did not apply.
Are acceptance criteria called out where inspections

or testing is required by the design output? List the
results of your review on pages 6 8.
Reference
ISO 9001 7.3.3
Design Review and Verification

Were the design reviews called out in the design
plan or local procedures conducted and recorded?
List the results of your review on pages 6 8.
Verification requirements should be called out in the design

planning documents, or they may be standardized in local
procedures. Verify all verifications required for this project
were completed.
Overall evaluation:
Did not check.
Did not apply.
Were there actions arising from the reviews?

Consider issuance of an OFI if reviews rarely result
in actions (i.e. if it looks like we are going through
the motions).

Were all open and outstanding actions arising from

the reviews followed up on and closed out? List the
results of your review on pages 6 8.
Did reviews include adequate representation of all

concerned parties?
Reference
ISO 9001 7.3.4-.5
Design Validation
Was the product validated prior to release?
Were the validations called out in the design plan

and/or local procedures conducted and recorded?
List the results of your review on pages 6 8.
Validation tests should be called out in the design planning

documents, or they may be standardized in local procedures.
Verify all validations required for this project were completed.
Overall evaluation:
Did not check.
Did not apply.
Were there actions arising from the validation?

Were all open and outstanding actions arising from
the validation followed up on and closed out?
Reference
ISO 9001 7.3.6
Design Changes
Are all design changes identified, documented and
reviewed prior to implementation? Verify contract
amendments relating to design noted on page 3 were
incorporated into the final design.
This section verifies that any design changes made prior to or

after launch were properly reviewed and communicated prior
to their release.
Overall evaluation:
Did not check.
Did not apply.
10
Is the impact of the change on other

systems/components considered?

Is the impact of the change on delivered product

considered?
Reference
ISO 9001 7.3.7
This section verifies that personnel involved in design

activities have the necessary level of training and competency,
and are aware of their roles, responsibilities and authorities for
producing a high quality product.
Have the specific competencies used in our design

and development process (e.g. Quality Function
Deployment, FMEA, Finite Element Analysis, etc.)
been identified in the competency matrices or
equivalent?
Overall evaluation:
Did not check.
Did not apply.

design and development. Pay particular attention to
design reviews, design changes and approvals.

Is there evidence that the product design process is

effective? Answer the questions on pages 6-8, along
with reviews of process metrics to evaluate design
process effectiveness.
Individual Name
Training?
Awareness?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Overall evaluation:
Did not check.
Did not apply.
11
Quality Planning
This interview may be with a different individual,
such as a quality or process engineer responsible for
process design and development, or it may be part
of the general design control procedure headed by
the lead design engineer.
Do we have a procedure for quality planning? Ask
to see the procedures. Note the numbers and
revision date for later confirmation of document
control.
Can you walk me through our process for planning

for a new product?
Have the auditee walk you through the design
process, verifying the information below as you go.
During the interview, have them show you records
of any required reviews using your test objects you
previously selected.
This section focuses on process design and development. Most

of the requirements will be contained in local procedures and
instructions. The auditor must modify this section to include
these local requirements.
Procedure
No.
Rev. Date
Overall evaluation:
Did not check.
Did not apply.
Is a systematic process used for quality planning? Is

it consistent with the documented procedure
requirements?
Has some type of plan been developed to guide the
quality planning efforts? Review the plan. Verify
actions called out on the plan were completed.
Does/did the quality planning process consider, as

appropriate:
Procedures and records
Machinery, equipment, tooling
Verifications, inspections, testing
Special skills, methods and resources

This section verifies that personnel involved in process design

activities/quality planning have the necessary level of training
and competency, and are aware of their roles, responsibilities
12

Have the specific competencies used in our design

and development process (e.g. Lean Manufacturing,
Process FMEA, etc.) been identified in the
competency matrices or equivalent?

quality planning? Pay particular attention to process
reviews, process design changes and approvals.
and authorities for producing a high quality product.

Overall evaluation:
Did not check.
Did not apply.
Individual Name

Training?
Awareness?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Specific Competencies
Performance and Effectiveness

Is there evidence that the quality planning/process
design and development process is effective?
Answer the questions in the right-hand column,
along with reviews of process metrics to evaluate
quality planning process effectiveness.
Overall evaluation:
Did not check.
Did not apply.
Performance
Did the Project Launch On-time/Is it On-track
Note that if product design was a part of this

contract, then overall effectiveness of the quality
planning process will be indicated by the questions
included on pages 6 8.
Yes
No
Identified?
Yes
No
Yes
No
Yes
No
Yes
No
The following questions are only applicable to projects that

have been launched.
Yes
No
Lessons Learned developed for this project?
Yes
No
Indicator/Metric
Value
Trend
1. ___________________________ ________ _________

2. ___________________________ ________ _________
Internal Communication
Are personnel aware of how well the quality
planning or product design and development
process is performing? Are they provided with
information relating to process performance (e.g.
The purpose of internal communications is to ensure that

personnel are aware of significant information relating to the
performance of their process or the product. Verify that
personnel are aware of any metrics, objectives or goals
established for quality planning and/or product design and
13
design cycle time, # ECRs, etc.)? Can they

communicate the major design/customer issues
relating to this area or process? Refer back to your
review of customer concerns, complaints and returns
on page 1.
Is there a formal process for handling customer

complaints relating to design issues? Is it being
used?
development.
Overall evaluation:
Did not check.
Did not apply.
Major design issues from page 1.
Awareness?
Is the complaint handling process effective? Your

review of customer complaints and product returns
should indicate whether actions are being taken as a
result of customer complaints and concerns.
Are personnel aware of any quality objectives
established for this activity? Is there any evidence
that progress is being made towards their
achievement? These were listed on page 1 during
your audit planning. Issue an OFI if personnel are
not aware of quality objectives affecting this area.
Yes
No
Yes
No
Yes
No
Reference
ISO 9001 5.5.3, 7.2.3
Resource Management
Does it appear that adequate staffing (right number
and right skills) has been provided for quality
planning and design and development activities?
Are there any problems related to this process that

can be directly tied to the non-availability of a
resource? Question resources when process
performance data reviewed previously indicates
poor or a deteriorating level of performance.
Resource availability and use is a difficult area to audit. The

auditor should look for problems, possibly connected with
other questions asked, that can be tracked back to nonavailability of resources. Unless there is a related violation,
then resources are considered adequate.
Overall evaluation:
Did not check.
Did not apply.
Resource Issue
Impact on Performance
Reference
ISO 9001 6.1
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ISO 9001:2000 General Requirements Order Generation, Quality Planning and Design

Planning the Process Audit

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

Determine the processes/activities to be included in the scope

Consider the following information relating to the processes to

Review the core process metrics relating to sales, marketing

2004 Joe Kausek & Associates

General Process Audit Guidance

Start with the Account Manager/salesperson and evaluate the

Part One Order Generation (Sales or Account Manager)

Is there a process for identifying customer specified

2004 Joe Kausek & Associates

Are the product requirements noted above reviewed

2004 Joe Kausek & Associates

feasible to manufacture, without undue risk?

If verbal orders are received by the organization, are

Is there a process in place to control contract

Training and Awareness

Is there evidence that the process was effective in

1. ___________________________ ________ _________

Part Two Quality Planning and Design (Lead Project Engineer)

Design Planning/Quality Planning

Can I see a list of projects still under development?

Can you walk me through our process for designing

Test objects selected still under development

Is a process in place to plan the design and

2004 Joe Kausek & Associates

Design Planning and Verification Worksheet

Did the Project Launch On-time or Is it On-track

Did the Project Launch On-time or Is it On-track

Contract/Part No. ____________________________

Did the Project Launch On-time or Is it On-track

The auditor should verify that the customer requirements

Functional and performance requirements? Verify

List key requirements and indicate the results of

Is there evidence that lessons learned from previous,

Does design output contain adequate information

This section verifies that the design outputs (specifications,

Are acceptance criteria called out where inspections

Design Review and Verification

2004 Joe Kausek & Associates

Verification requirements should be called out in the design

Were there actions arising from the reviews?

Conforms. No deficiencies identified.

Were all open and outstanding actions arising from

Did reviews include adequate representation of all

Were the validations called out in the design plan

Validation tests should be called out in the design planning

Were there actions arising from the validation?

2004 Joe Kausek & Associates

This section verifies that any design changes made prior to or

Is the impact of the change on other

Opportunity for improvement. Detail below.

Is the impact of the change on delivered product

This section verifies that personnel involved in design

Have the specific competencies used in our design

Is the auditee aware of their specific roles and

Is the auditee aware of the quality policy, and how it

Is there evidence that the product design process is

2004 Joe Kausek & Associates

Can you walk me through our process for planning

This section focuses on process design and development. Most

Is a systematic process used for quality planning? Is

1. ___________________ _

1. ___________________ _