For Dept/Function: CFT

Internal Audit Check List

Auditor:

QMS Process: New product development Date of Audit:

If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
7.3 Manufacturing process design & Development
Does the organization identify, document and review > Productivity, process capability,
the manufacturing process design input requirements, costs targets
including: > Regulations
- product > Customer
design output data ? requirements, if any
- targets for productivity, process capability and > Experience
cost ? from previous development

- customers requirements if
any ? - experience from
Does the organization identify special characteristics > Process to establish special
and : characteristics
- include all special > Design Record
characteristics in the control plan
> Review customer requirements
- comply with customer specified definitions and for special characteristics, definitions
symbols ? and symbol identification
>
- identify process control Control Plans
documents including drawings, FMEAs, control > Product drawings
plans, and operator instructions with customer's >
special characteristic symbol or the organization's Operator instructions
equivalent symbol or notation to include those process
steps that affect special characteristics ?

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 If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
Does the organization use a multidisciplinary > Functions represented in product
approach to prepare for product realization, including: development teams.
- development/finalization and monitoring of special > Personnel involved in definition
characteristics? of special characteristics, FMEA, and
- development, and review of FMEA's including PCP.
actions to reduce potential risks?
- development, and review of PCP?

Is the organization's manufacturing process design > Process specifications and

output expressed in terms that can be verified against drawings
manufacturing process design input requirements and > Process FMEA's
validated ? >
Job instructions
> Process
approval acceptance criteria
> Quality,
reliability, maintainability data
>
Mistake proofing activities results
> Non-
conformity detection methods
Does the organization's manufacturing process design > Availability of all applicable
output include: process design output documents
- specifications and drawings?
- manufacturing process flow chart / layout?
- manufacturing process FMEAs?
- control plan?
- work instructions?
- process approval acceptance criteria?
- data for quality, reliability, Maintainability and
measurability?
- results of error- Proofing activities, as appropriate?
- methods of rapid detection and feedback of
product/manufacturing process non - conformities?

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 If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
Does the organization perform systematic reviews of > Design review planning records
design and development at suitable stages in > Design
accordance with planned arrangements: review extended to all functions
a) to evaluate the ability of the results affected by it. >
of design and development to fulfill requirements? Link of corrective action to status
b) to identify any problems and propose necessary reviews
actions?

Do the participants in the systematic reviews of design > Link of corrective action to
and development identify any problems and propose status/design reviews
necessary actions?
Are the records of the results of the reviews and any > Design review planning and
necessary actions maintained by the organization? records maintained

Does the organization define and analyses
measurements at specified stages of design and
development and reported with summary results as an active projects
input to management review?
Does the organization perform design and
development verification in accordance with planned
arrangements to ensure that design and development
outputs have satisfied the design and development
input requirements?
> Project reviews at different phases
of product realization process for all
> Design verification done in
according to the planning
> Comparison
between outputs and design
requirements >
Corrective actions based on results

Does the organization maintain records of the results > Design verification reports
of the verification and any necessary actions?

7.1 Planning of product realization

Has the organization planned and developed the > Quality planning process
processes needed for product realization? > Project planning
process >
Quality plans for new products
Is the organization's planning of product realization > Development of Quality plan (s)?
consistent with the requirements of the other
processes of the quality management system?

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 If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
In planning product realization, does the organization > Quality plan and Design record,
determine the following, as appropriate: control plan, operator instruction,
a) quality objectives and requirements for the product? product approval records,
b) the need to establish processes, documents, and resources/facilities and any plans to
provide resources specific to the product? enhance them
c) required verification, validation, monitoring, > Design
inspection and test activities specific to the product validation at the various stages of the
and the criteria for product acceptance? design
d) records needed to provide evidence that the > Link between process changes and
realization processes and esulting product meet updates in the quality plan (s)
requirements?

Is the organization's planning of product realization > Product realization output format
output in a form suitable for the organization's method & content
of operations?

Are the customer requirements and references to its > Quality plans
technical specifications included in the planning of > Customer
product realization as a quality plan? specifications
> Technical specifications
7.1.2 Acceptance criteria
Did the organization define acceptance criteria for the > Test specification
product being developed and where required, > Product validation test
approved by the customer? plan with defined acceptance criteria

Is the organization's acceptance criteria for attribute > Acceptance criteria in test plan and
data sampling zero defects? test specifications

7.2.1.1 Customer designated special characteristics

Can the organization demonstrate conformity to > Designation and control of special
customer requirements for designation, documentation characteristics
and control of special characteristics? > Quality documents:
control plan, specifications,
drawings, etc shall report the special
characteristics designation

7.5.1.5 Tool & Fixture development

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 If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
Does the organization provide resources for tool and > Tool/gage design staffing and
gauge design, fabrication and verification activities? qualification.

Does the organization establish and implement a > Tool management process.
system for tooling management including:
- maintenance and repair facilities and personnel?
- storage and recovery?
- set-up?
- tool-change programmers for perishable tools?
- tool design modification documentation, including
engineering change level?
- tool modification and revision to documentation
defining the status?
- tooling identification defining the status

Has the organization implemented a system to > Subcontractor management system

monitor its tooling management activities if any work (choice, evaluation and control)
is outsourced?
7.2.2.1 Organization manufacturing feasibility
Does the organization investigate, confirm and > Feasibility studies
document the manufacturing feasibility of the > Risk analysis
proposed products in the contract review process
including risk analysis?
7.3.6 Product and manufacturing process validation
Does the organization perform design and > Design validation against user
development validation, accordance with planned requirements / needs.
arrangements to ensure that the resulting product is > Comparison between customer
capable of meeting the requirements for the specified plan and internal development plans.
application or intended use, where known? > Design validation records.
> Document failure.

Wherever practicable does the organization complaint > Completion of product validation
design and development validation prior to the testing prior to start of production.
delivery or implementation of the product?

Page 5 of 7
 If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
Does the organization maintain records of the results > Product validation test report
of validation and any necessary actions? > Corrective action
process for the design activity
>
Corrective action records
Does the organization perform design and > Design validation against user
development validation in accordance with customer requirements/needs
requirements including program timing? > Comparison
between customer plan and internal
development plans
When required by the customer, does the organization > Prototype facilities
have a prototype program and control plan?
> Prototype
records
Wherever possible, does the organization use the same > Design / prototype / production
suppliers, tooling and manufacturing processes as will tooling
be used in production? > Product realization and
test conditions must be known and
controlled

Does organization monitor all performance testing > Test records

activities for timely completion and conformance to
requirements?

Is the organization responsible for the subcontracted > Subcontractor management as

services, including technical leadership? appropriate

7.3.6.3 Product approval process

Does the organization conform to a product and > Compliance with customer
process approval procedure recognized by the requirements regarding product
customer? approval process
Does the organization apply a product and process > Product approval process
approval procedure recognized by the customer to its documentation and records for
suppliers? suppliers.
7.1.4 Change control (Product Change)
Does the organization have a process to control and > Engineering change request
react to changes that impact product realization process
including those initiated by the supplier? >
Change records

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 If Non-
ISO/TS Conforming conforming Auditors Comments
16949:2002 Requirements What to look for Auditee Name
Audit Report (When required)
Clause Ref
Yes No No.
Does organization assess the effects of changes? > Impact study including proprietary
design
> Change
management process
Has the organization defined the verification and > Test specification
validation activities for changes, to ensure compliance
with customer requirements? >
Product validation test plan with
Does the organization validate changes before > Evidence of design and production
implementation? validation tests conducted for product
changes
Does the organization review proprietary designs, > Impact study including proprietary
impact on form, fir function, (including performance, design
and/or durability) with the customers that all effects >
can be properly evaluated Change management process

Does the organization meet additional

verification/identification requirements such as those
required for new product introduction when required
by the customer?

4.2.3.1 Engineering specifications

Does the organization have a process to assure the > Process for notification/distribution
timely review, distribution and implementation of all of customer engineering standards
customer engineering standards/specifications and changes
changes (including the updating of appropriate
documents) based on customer required schedule? > Process
for implementation of customer
initiated changes
> Document changes
triggered by engineering changes

Does the organization maintain a record of the date on > Records of engineering changes
which each change is implemented in production? implemented

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