DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES

QUESTION
EVIDENCE
FOLLOWCAR #, IF
UP
APPLICABLE
REQUIRED?
Design and development of products and services
Clause 8.3 (this checklist is to be used in
conjunction with the All Processes checklist)
1. Describe the design and development process.
2. (Review records for X recently closed projects to
verify the following:)

Project #

Project #

Project #

_________

_________

_________

a. Was there a design plan for each project?

b. Did plans identify specific activities and the
individual responsible for completing them?
c. Did plans include the review, verification,
and validation activities that are appropriate
to each stage of the design?
d. Did plans consider internal and external
resource needs for the design and
development?
e. Who were the interfaces that were identified
for each project? How were they kept abreast
of the status of the design? (Pull records to
verify conformance.)
f. Was the need for customer and/or user
involvement considered in the design and

Design and Development of Products and Services

development process?
g. Did the organization consider the level of
control expected of the design process by
customers and other relevant interested
parties?
h. Were customer and regulatory requirements
clearly defined for each project along with
the functional and performance requirements
for the product? Were these requirements
reviewed and approved? (Pull evidence.)
i. How were lessons learned from previous
projects considered for each project?
(Review evidence to verify.)
j. Did the organization consider standards or
codes that it had committed to implementing?
What, if any, were they? How did the design
incorporate these? May I see it please?
k. How did the organization consider potential
consequences of failure due to the nature of
the products and services? May I see it
please?
l. Were any conflicting, incomplete, or
ambiguous requirements resolved?
m. Is there evidence for each project that the
design output (that is, prints, drawings,
specifications, verification and validation

Design and Development of Products and Services

results, and so on) met the customer and

regulatory requirements specified in the
question above?
n. Did design output include or reference
monitoring and measuring requirements as
well as acceptance criteria?
o. Do the output documents specify the
characteristics of the product that are
essential for its safe and proper use?
p. Are records available to show evidence of
design review for each project at the required
intervals? Were follow-up activities
recorded?
q. Were verification requirements clearly
defined and documented? (Pull records and
verify that requirements were successfully
completed or that follow-up activities were
recorded.)
r. Were validation requirements clearly defined
and documented? (Pull validation records and
verify that requirements were successfully
completed or follow-up activities were
recorded.)
3. Have any of the projects had changes? (If so,
verify that they were reviewed, verified,
validated, and approved as appropriate.) Were
any risks of adverse impacts identified? Do

Design and Development of Products and Services

records include the results of the review,

verification, and validation as well as any
necessary actions?
4. (Interview the customers of the design and
development process to ensure that the output is
providing adequate information to operations,
purchasing, maintenance, QA, and so on. Ask:)
a. Are operations personnel receiving adequate
information to run the process?
b. Are purchasing personnel receiving adequate
information (drawings, specifications, so on)
in time to order acceptable materials from
qualified suppliers?
c. Are QA personnel receiving adequate
information in time to effectively test the new
product?
d. Are maintenance personnel receiving
adequate information to effectively maintain
the equipment?

Design and Development of Products and Services