498 Appendix IV
Required Criteria of Requirements Verication Possibilities
5. Quality is independent of the
operational directions. It has
authority to stop production in
the event of nonconformity.
Human resources
for all operation
activities are
evaluated and
continuously
managed.
1. There is a formalized process to
identify new resources needed.
2. Rules are dened for its
implementation in the event of
modication of organization or
process, evolution of production
program or new product launch,
etc.
3. The process integrates
management of the rates of new
employees including ratio of the
temporary staff based on
indicators of production schedule
and efciency.
Check whether new project
requires new staff.
Check process for identication of
needs (number of employees,
their qualication).
Predened plan based on
production needs (new shift/
additional operators, etc.).
For all new
facility/
equipment/
tools, etc.
(manufacturing,
control, logistics,
etc.) or in case of
revamping, a
structured
validation
approach is
applied.
1. Milestones are established and
aligned with project timing for
installation and validation of new
equipment/tools, etc.
2. Based on milestones, detailed
timing plan is established and
regularly followed up for
validation process. In case of any
delay/deviation, actions initiated
including notication of customer.
3. The qualication process aims to
verify compliance with
specications, contract, and
performance (productivity,
capability, quality) of equipment.
In the case of gauges, it also
integrates equipment calibration.
4. Dedicated resources assigned for
qualication of equipment,
connected to maintenance.
Check whether new project
requires new facility/
equipment/tool, etc.
Check process for identication of
needs.
Check new equipment and its
documentation for qualication,
technical data, and maintenance.
For every new
product/process
or signicant
product/process
changes, the
product/process
qualication is
dened,
continuously
tracked, and
nally approved.
1. Milestones are established and
aligned with customer project
timing for product/process
qualication.
2. Based on milestones, detailed
timing plan is established and
regularly followed up; their results
are shared with the customer.
3. Qualication process includes all
manufacturing processes
(including outsourced),
components, tier parts, and raw
materials.
Check a timing plan for an
advance project.
Check a qualication package
(PPAP) and crosscheck a few
elements (e.g., gauge R&R,
dimension and material report,
function/durability result,
capability study).
Check an R&R result.
499Appendix IV
Required Criteria of Requirements Verication Possibilities
4. Deliverables to the customer are
managed and controlled. Customer
product approval status is known
and tracked for all products.
5. Capacity analysis with its
verication, process audit, and
capability of key characteristics
are part of qualication process.
6. Any deviation is treated; action
plans are led by the project manager
and/or his or her representative on
site. Customer is notied.
Check qualication (PPAP)
conrmation from customer.
Service parts (SP)
production
process is
managed and
controlled
during and after
the mass
production
phase.
1. A process to manage “end of life”
of current production of reference
part number is deployed. It takes
into account the quantities of SP
remaining to produce (strategy
dened, e.g., prepare stock to
cover SP demand, keep tool,
production transfer, etc.).
2. In order to maintain efciency and
effectiveness of production and
measurement equipment
dedicated to SP, specic
procedures of storage and
maintenance are applied (e.g.,
storage conditions, 6S, oiling,
protection against dust, etc.).
3. Specic operations or processes
for SP (e.g., specic marking)
production are industrialized,
managed, and controlled
according to the same methods as
mass production process.
4. In the event of storage of SP for a
long period before shipping, a
process is applied in order to
guarantee the safeguarding of the
parts (intermediate packaging,
new storage areas, etc.).
Business planning + production
master plan (verify that SP needs
are included).
Example of “end of life”
production.
Process qualication of specic
operations.
SP storage.
Procedure for long storage.
Product packaging
(nal product,
intermediate, and
supplies) and
handling
equipment are
designed and
validated to
guarantee product
conformity.
1. Packaging is dened during
product design phase (take into
account in project milestones).
The technical specication is built
based on customer needs and is
approved by the customer
(drawing of packaging).
An example of technical
specications.
An example of packaging.
Packaging part protection
material.
PFMEA concerning handling and
storage.
Storage CP when necessary.
Test result (static and dynamic).
(Continued)
500 Appendix IV
Required Criteria of Requirements Verication Possibilities
2. Packaging is designed in order to
protect product from damages.
3. Test procedures and validation
process are shared with the
customer. Static and dynamic
tests are implemented. Test
reports are available.
4. The denition of the storage and
handling conditions starts during
product/process design phase
and are shared with the
customer.
5. Handling and transportation
equipment design is done taking
into account risks of degradation
of product quality.
Part and Process Control
There is a system
to guarantee the
availability to
users of the
documents at the
latest version at
the right place.
All the technical
information is
available.
1. A standardized process
guarantees that all the users have
access to the latest versions of the
documents.
2. Revision history available for
each document.
3. Customer approved drawings
are available at production
facility with the latest change
level.
4. Drawing is completed with all the
product characteristics
(tolerances, GD&T, correct
datums, key process
characteristics [KPCs], etc.).
5. All technical regulations are
available at production facility.
Prior to audit, check drawing date
and engineering change level of
latest customer drawing.
All technical regulations referred
to in drawing are available.
All the key
characteristics
are identied in
order to ensure
their proper
control.
1. All the key characteristics dened
by customer are identied in
PFMEA and CP.
2. Key customer characteristics are
deployed to process
characteristics if applicable.
3. If applicable, they are
communicated to tier suppliers,
necessary controls are veried
and conrmed.
4. Required customer controls (e.g.,
SPC) applied for key
characteristics.
5. Pass-through characteristics are
identied and controlled.
6. EP strategy is applied.
Check all the key characteristics
deployment into documentation
(PFMEA, CP, and working
instructions), verify their control
effectiveness.
Ask operators about awareness of
key characteristics.
501Appendix IV
Required Criteria of Requirements Verication Possibilities
All the operations
are listed and
charted in
process ow
diagram.
1. All process steps including
logistic ow are listed and
charted.
2. The ow chart is used as an input
for PFMEA.
3. Link ensured between process
ow, PFMEA, and CP.
Process ow includes receiving,
all the operation steps, rework,
scrap, gauging/inspection,
shipping, labeling and Part ID at
receiving, waste in process
(WIP), nished goods, and
shipping.
Flow is clearly arranged.
Workplace properly congured
and matches with process ow
diagram.
Check link/number matching
between process ow, PFMEA,
and CP.
CP is available for
each product in
order to dene
necessary
controls needed
to be performed.
1. A CP is available for each product
and process.
2. All current controls are listed on
the PFMEA detailed on the CP.
3. CP denes the characteristics and
the parameters to be monitored,
the specications and the
tolerances, the control
frequencies, the methods, the
equipment, the records, and the
reaction plans (in the event of
nonconformance).
4. Sample size and frequency take into
account process and measurement
capabilities, phase of project, and
how often reaction is needed.
5. CP is reviewed systematically in
the event of PFMEA review.
CP addresses print requirements
relative to dimensional, material,
rust preventative, heat-treat,
micro-nish, contamination/
sediment, etc.
Sample sizes and frequency for
each operation are reasonable
(e.g., based on internal data:
scrap, rework, FTQ, etc.).
Evidence that CP is being
updated.
Checks to be done under the PCP
requirements are performed.
Statistical process
control (SPC) is
applied.
1. Characteristics, where SPC needs
to be applied, are dened in CP
based on customer and process
capability requirements.
2. Sample size and frequency are
dened according to the stability
of the process.
3. Control limits are calculated for
each characteristic according to
the capability target and updated
based on trends.
4. Results are documented via
control charts and used for
process capability calculation.
Result needs to meet customer
requirement.
5. Out of control point is noted with
corrective action taken.
Where the PCP calls for SPC, look
at actual SPC records and data
collection:
- All data boxes lled in
- Control limits calculated
- Trends/patterns are present
that would indicate a need to
recalculate limits
- The limits actually are control
limits and not spec limits.
- Verify that every out of
control point is noted and
corrective action dened and
followed by leadership.
- Ask someone noted on the
action plan to explain his or
her involvement and/or
responsibility.
(Continued)
502 Appendix IV
Required Criteria of Requirements Verication Possibilities
6. Leadership periodically reviews
SPC results and ensures that out
of control conditions are
managed.
- Manufacturing process
demonstrates the required
capability or performance
(based on SOR requirements).
Results of control
are recorded and
archived as well
as analyzed to
correct
deviations and
improve
processes.
1. Control records are documented
(using standard forms or
information systems) according to
CP requirement.
2. Control records must guarantee
product/process traceability and
conformity and are archived
according to customer traceability
requirements.
3. Results are reviewed, out of
control point are noted.
4. Actions are implemented in
accordance with reaction plan
dened in CP.
5. Results are analyzed for CI
activities.
All results recorded where CP
requires. Records are readable.
Out of control points are noted,
necessary action implemented.
Track back records to check results
are archived, traceability
ensured.
The information
systems are
managed in
order to secure
all the data
related to
complete
material ow of
product.
1. A list of critical information systems
is established and managed.
2. Resources are identied,
qualied, and available during all
production periods. The
responsibilities are dened for
each critical information system:
- To guarantee the availability and
the integrity of the data
- To ensure the breakdown service
in case of failure
- To implement needed functional
evolutions
3. There are procedures of backup
and recovery of the data and they
are regularly tested.
4. For all main changes concerning
critical information systems, a
qualication process is carried out
prior to full implementation.
List of critical systems (system
connected to the material ow
management, software,
programs, system related to the
traceability of the parts,
incoming, and shipping).
Resources are available onsite to
manage IT and experts on short
term.
Check backup plans for loss of
data/computer breakdown/
network breakdown.
Specic procedure for degraded
modes.
Product audits
(including dock
audit as well) are
dened and
performed
according to CP.
1. Product audit procedure is
dened and performed according
to CP and all the results are
documented.
2. Product audits completely cover
KPC verication.
3. Product audit is considered SW.
4. Decision criteria to alert the
customer are dened.
5. In case of outsourced test, labs
must be certied.
CP denes product audit clearly.
Check product last audit results.
Was it performed according to
required frequency?
In case of any NOK results, action
taken.
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