The minimum requirements for preliminary and ongoing process are defined by the OEM/Johnson Controls. In the absence of specific
requirements the following are to be met:
a) Preliminary process capability (requirement): Cp, Cpk 1,33
b) Process capability in production (requirement): Cp, Cpk 1,67
Before initial sample inspection, the process ability to run at rate must be evaluated over a minimum of
3 hours or 300 parts, and should include a minimum of 1 process change if the process is not
dedicated. The capability of all CCs and SCs must be confirmed from sequential components
manufactured under serial production conditions.
3.5 Initial Sample Inspection
The goal of an initial sample inspection is to demonstrate, before serial production begins, that the
quality requirements agreed on in the drawings and specifications have been fulfilled. It is used for
eliminating systematic faults before serial production begins or before approval is given for serial
production.
Initial sample inspection is conducted as specified in the QS-9000 PPAP or VDA publication “Assuring
the Quality of Supplies” which is no. 2 in the series “Quality Management in the Automotive Industry,”
with a distinction being made between the types of samples:
a) “Other samples” are products and materials, which were not entirely manufactured under serial
production conditions or for other purposes
b) “Initial samples” are products and materials, which were manufactured entirely under serial
production conditions and with serial production operating resources.
The main requirement for a successful initial sample inspection is that the initial sample inspection
report forms are correctly and completely filled out, as specified in VDA publication no. 2 or the QS-9000
PPAP procedure.
If the initial sample inspection was not passed on account of non-conforming first pieces, after
consultation with the purchaser the supplier must draw up a written list of corrective actions, giving for
each corrective action the planned implementation date and the person responsible for it. In addition, a
date must be agreed on for the repeat initial sample inspection.
If the initial samples have not been fully approved by the purchaser, the release for mass production will
not be given.
3.6 Storage, Packing and Labeling
Products are stored with the supplier in such a way that they are adequately secured against loss or
theft and so that damage or impairment of material properties due to environmental influences is
excluded. It is the supplier’s responsibility to provide the requisite packaging, unless otherwise specified
by the purchaser. Where the transport is the responsibility of the supplier, damage to the products
during transportation or shipping must also be excluded.
The supplier shall label the products in such a way that the product status and the testing and inspection
status are clearly recognizable at any time, from receipt of the raw material until dispatching of the
products. At the outgoing products stage the type of identification labelling specified by the purchaser
shall be used (if prescribed).