Auditing of NEW PRODUCT DEVELOPMENT PROCESS

AND PRODUCT REALISATION PROCESS – (PART – I)

- Take 2 samples i.e. one from Under Development & One
from already developed & productionised.
- Take one no. of product which is developed and do lay out
inspection (Dimension and material) and functional test – if
possible.
- Verify Customer drawing and specification
- Verify Feasibility Commitment based on Feasibility Review,
which covers Technical, commercial, Quality system, Risk
Assessment, Customer specific requirements if any.
- Reference Standards mentioned in the Customer drawing are
available?
- Verify Statutory and regulatory requirements are applicable
- Verify Contract Review records
- Verify Timing Plan covering all the stages of new product
development (Gantt Chart)
- Verify APQP Status Report
- Verify the status of new product development covered as part
of MRM
- Special Characteristics are addressed in FMEA, CP, WI and
stage drawings with the Customer Designated Symbols?
- Verify various Stages of Design and Development
- Verify targets for Product Quality, life, reliability, durability,
maintainability, timing, cost are set and tracked as part of
Product Design Input?
- Verify Design FMEA (System/Sub-System/component),
Design Review, Design Verification Plan and Results.
- Verify Target for Productivity, Process Capability, Cost and
are tracked or not as part of PROCESS DESIGN?
- Verify the Team use the previous design experiences
- Verify Prototype Programmes as applicable
- Verify Plant Lay out plans

1
- Verify Stage drawings (sample), PFD, PFMEA, CP (3 stages-
Prototype, Pre- Launch, Production) for the linkages, analysis
and controls (MDT approach in Spl. Characteristics
identification, FMEA and control plan preparation and
periodical review)
- Verify Product Approval Process Criteria where there are
Spl. Characteristics and No Special Characteristics and check
for compliance
- Verify Process Validation (Qualification) and re-validation
for all key processes including operator qualification (Skill)
- Work Instruction (covering Set-up, Process, Rework)
accessible at the work station
- Verification of Job set-ups?
- Predictive and Preventive Maintenance Process covers Key
process equipments?
- Critical Spare parts are identified and maintained as per stock
level?
- Documented Maintenance objective and tracking including
MTTR and MTBF?
- Production tooling Management covers – Tool change
programmes for Perishable Tools, Tool Design
Documentation including Modification/ revision levels,
Tooling identification, Tooling Outsourcing is monitored?
- If servicing is applicable, verify the effectiveness or process
as per agreement with customer.
- Verify the internal identification and traceability system at all
stages on the product.
- Customer property is handled as per the requirement?
- First level product measuring and process measuring
Instruments/equipments are calibrated at a frequency (Bias,
Uncertainty and Linearity)?
- Calibration Records and Master list of Calibration evident for
all the instruments with frequency of calibration?
- Identification of calibration status in the instrument evident?

2
 - If any out of calibration situation, records are maintained to
confirm the validity of previously measuring results?
- MSA (Stability, Gauge R & R (Variable and attribute))
conducted for the type of MS?
- Lab Manual and Scope for Internal Laboratory (including
qualification of personnel)
- External lab is NABL accredited with the scope of
instrument?

Auditing of NEW PRODUCT DEVELOPMENT PROCESS

AND PRODUCT REALISATION PROCESS – (PART – II)
- Verify List of Approved Suppliers including Customer
Approved Source
- Verify Supplier Selection and Evaluation process (Sample 2
suppliers)
- Verify if any hazardous material in incoming material and
verify compliance as per applicable regulatory requirements.
- Supplier Development including ISO 9001:2000 evident?
- Verify P.O of suppliers for adequate information like part no.
including rev. level, delivery terms and conditions,Quality
System Requirement, Special Characteristics information,
Operator Skill for critical processes, organization or customer
audit at supplier premises,etc
- Verify Supplier Product Approval Process
- Verify Supplier Vendor Rating covering Quality, Delivery
(including excess freight), Customer complaints (including
field complaints), Special Status customer notifications, if
any.
- Verify Supplier periodical audits by organisation
- Organisation commitment of promoting supplier (improving
their manufacturing process)
- Verify incoming product quality – Receipt or evaluate
statistical data / Receiving inspection by sampling / Second

3
 or third party assessments of their product quality / part
evaluation by any other laboratory / any other method agreed
by customer.
- Verify identification, storage, protection, handling, packaging
of product in stores whether proper?
- Shelf life item identified and assessed at a frequency?
- Hazardous materials are handled as per MSDS
recommendations?
- FIFO followed for all the materials including finish goods?
- Verify the inventory status and plan for reducing the
inventory (raw material and finish goods)