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QRL-0010001 FMC Standard Administration Requirements: - Revision P, released August 19, 2011 - Appendix F Quality Requirements, section 1.5 & 1.6
10/29/2012
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Learning Objectives
Why and when FMC require an Inspection & Test Plan (ITP). What the requirements are. The responsibilities of issue, review and handling. Why and when FMC require intervention points. The different types of intervention codes. Notification requirements content & communication.
Purpose
Inspection & Test Plan is a basis for verifying conformity with specified contractual requirements.
For FMC and the Supplier to establish and agree upon the following prior to production start;
Quality Control activities Interventions for the Supplier, FMC, FMCs customer and/or Third Party Intervention points allow the parties to go into different steps in the production process to assure the quality.
What
ITP is listing the sequence of activities, and shall as a minimum include: All important production processes in all phases of production. All examinations, inspections and tests to be performed with reference to applicable inspection and test procedures, and type of verifying document. Location of activity. Suppliers Intervention activities (witness, hold, etc). Interventions columns for FMC, 3rd party and Customer. Health, Safety & Environment (HSE) intervention point prior to critical tests, if any. Pre-Production Meeting (PPM) to preferably be an activity in the ITP.
Pre-Production Meeting (PPM): To determine whether the Supplier is ready to start production.
Supplier to call for meeting, FMC responsible for documenting the findings, often with FMC customer. All clarifications between FMC and supplier shall be done prior to PPM.
ITPs shall be listed on the SMDR (Supplier Master Document Register) If any change in manufacturing process on an ongoing ITP, the ITP shall be revised and resubmitted to FMC for review and approval.
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Responsibilities; Review
FMC responsible Quality personnel shall review
FMC to review and return document to Supplier within twenty (20) Business Days, or longer if the document shall be reviewed by FMC Customer as the case may be.
For every review cycle (revision) the supplier will receive a DR-4 document (Design Review) from FMC. The DR-4 document will have an Approval Status Code and may have comments for action or information. If comments, Supplier shall re-submit updated document within 10 Business Days. (if not otherwise agreed in the contract)
Responsibilities; Review
The Approval Status Code and the DR reference shall immediately be recorded in the SMDR by the supplier.
Approval Status Codes: 1 Accepted with no comments 2 Accepted with comments incorporated. Revise and resubmit. 2x Document returned before the customer's final approval/comments. Hold next revision of the document until receipt of FMC final comments, or document is given approval status code 1. 3 Rejected 4 Information
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Intervention Codes
R = Review:
Documentation and records shall be available for verification at any time by
FMC/Customer representative.
M = Monitor:
Activity will proceed as scheduled, without advance notification, but is subject to FMC/Customer witness as and when required. Monitor activities
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Intervention Codes
W = Witness:
A critical step in manufacturing or testing where it is desirable that FMC and/or Customer representative participates in the inspection / process activity of the material / equipment in order to ascertain that the product for delivery complies with the specified requirements. Formal advance notification shall be given. The step can proceed with or without the presence of FMC and/or Customer representative after the designated time has passed.
H = Hold:
A critical step in manufacturing and testing where it is essential that FMC
and/or Customer representative participates in the inspection /process activity of the material / equipment in order to ascertain that the product for delivery complies with the specified requirements. Formal advance notification shall be given . The step shall not proceed without the presence of FMC and/or Customer representative, or without a written statement giving a waiver. 14
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Notification Format
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Notify
All notifications to FMC Kongsberg (including updates) shall be sent to: FKSnotifications@fmcti.com
E-mail subject: FMC Project code & name, PO number (but not limited to) Copy relevant personnel, such as Commercial point of contact and Quality resource
Notification time shall be minimum 10 business days unless otherwise formally agreed.
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Be aware
Recurring problems: Documentation is a bottle neck
Internally in FMC FMC Customer Contact FMC purchaser if delay in documents
If several Part Numbers (PN) are included in one ITP Be very clear on which procedure belongs to which PN Multiple ITPs for one PO if the manufacturing steps are different
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Be aware continue
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. Any special agreements with FMC or Customer (shorter notification time, document approvals etc) shall be clearly stated in the notification. An email shall only contain notifications for one project.
Notifications
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Summary
Where to find out if we require an ITP for the Part? Where to find out the required content of an ITP? When shall the ITP intervention points be agreed? When do the supplier need to update and resubmit ITP? When shall the notifications be sent to FMC? To whom shall the notifications be sent?
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