Professional Documents
Culture Documents
Inspection & Test Plan (ITP) / Manufacturing Process Quality Plan (MPQP)
Inspection & Test Plan (ITP) / Manufacturing Process Quality Plan (MPQP)
Inspection & Test Plan (ITP) / Manufacturing Process Quality Plan (MPQP)
– "Yes" or "No" drop down menu for ‘Do the subcomponent (lower level) Part Reports
(DBIs) require Q00392? If so, are the lower level Part Report requirements included
in this ITP? ‘
– Note: The ITP may contain subcomponent Part Report (DBI) requirements in one
single ITP, only if the subcomponent Part Reports (DBIs) require Q00392
– Note: If Q00394 (for Product MPQP) is on the Part Report for Raw Material,
subcontractor of the Raw Material shall provide an MPQP acc to Q00394 to the
Supplier that will ensure FMC approval.
• NOTE Q00398 shall only be used by suppliers executing document approval through
eSMDR/SMDR, otherwise Q00394 shall be used to maintain traceability.
• Cycle Times
• FMC to review and return document to Supplier within
twenty (20) Business Days.
• Supplier shall re-submit updated document within five (5)
Business Days.
• For every review cycle (revision) the supplier will receive a
DR-4 document (Document Review) from FMC.
• The DR-4 document will have an Approval Status Code and
may have comments for action or information.
Approval
Approval Status
Status Codes:
Codes:
11 Accepted
Accepted with
with no
no comments
comments
22 Accepted
Accepted with
with comments
comments incorporated.
incorporated. Revise
Revise and
and resubmit.
resubmit.
2x
2x Document
Document returned
returned before
before the
the Company's
Company's final
final approval/comments.
approval/comments. Hold
Hold next
next
revision
revision of
of the
the document
document until
until receipt
receipt of
of FMCs
FMCs final
final comments,
comments, or
or document
document is
is given
given
approval
approval status
status code
code 1.
1.
33 Not
Not accepted.
accepted. Revise
Revise and
and resubmit
resubmit
44 Information
Information
• M = Monitor:
A step in manufacturing and testing that proceeds as
scheduled, and may be subject to FMC and/or Company
observation at FMC and/or Company discretion. Advance
notification is not required. Monitor activities are intended for
process verification, not product inspection.
• Recurring problems:
– Documentation is a bottle neck
• Internally in FMC
• FMC Customer
• Contact FMC purchaser if delay in documents
– Typing errors
• wrong / misspelled Purchase Order Number or Part Number
• several cases of ”copy-paste”
• FMC is working on methods to inform about required intervention
points at PO award.
– For BP projects requirements for intervention will be included in the Part
Report (DBI). Include those on first revision of ITP /MPQP
• Notifications
– Any special agreements with FMC or FMC’s Client (shorter notification
time, document approvals etc) shall be clearly stated in the notification.