1 control of non-conforming product & materials
TRANSCRIPT
Type 2 Nonconformance notification
Floor Plan – Hold Area, Quarantine Area, Scrap AreaOutdoor Storage Plan
SOP-0000 Control of Non-conforming Product & Materials
Start
Unidentified, unlabelled or non-conforming materials or products found during
Internal/External, Process or Customer Audits, health & safety audits, Materials
Management or by housekeeping are
segregated and identified as non-conforming
WI-______Process AuditWI-____ Health & Safety AuditWI-5021 Safe Handling of ChemicalsWI-7002 Handling and Storage of Raw Materials
Identification & SegregationAs applicable, Supplier Quality Specialist or Quality Assurance Supervisor
ensures suspect or known non-conforming materials are clearly identified & segregated or moved to designated HOLD/Quarantine area
Customer returns non-conforming product or notifies The Company of
Warranty issues resulting in known or
suspect Non-conformances
Customer CommunicationCustomer Corrective Action Request
Quality Assurance Department
upon notification from Supplier,
initiates action to trace, identify &
segregate suspect/non-conforming materials
WI-____ Processing of Defects
Notification by Supplier of defective
Shipped PartsExternal Returns
Engineering Design change results in
obsolete materials which must be identified and segregated
SOP-0011 Change Control –Product, Process, Sourcing
In-Process Handling / Production
Engineering
Process/ Customer / Health & Safety Audits, Materials
Management & Housekeeping
Respective Test/Audit results in
identification of non-conforming product
Per Quality Inspection and Test Plan (QITP)
Annual Validation Testing
Receiver/Quality Assurance identify & segregate suspect or non-conforming materials during inspection of incoming
material or supplier qualification
WI-7001 Receiving Inspection of Raw MaterialsWI-7000 Bulk Tanker OffloadingWI-5011 Testing Version DensityWI-5012 Testing Version Pot LifeWI-5013 Testing Version ViscosityWI-5014 Testing IsocyanatesWI-5015 Testing Version ResinWI-5018 Receiving Inspection of Fibreglass
Receiving Inspection - Supplier Qualification
5.2 Customer Focus7.2.3 Customer Communication7.4.3 Verification of Purchased Product7.5.5 Preservation of Product7.5.3 Identification & Traceability8.3 Control of Non-conforming Product 8.3.1 Control of Non-conforming Product - Supplemental8.3.3 Customer Information
4.2 Quality Requirements4.6 Periodic Re-qualification 4.16 Customer Feedback
Production and/or Quality Assurance Personnel identify &
segregate known or suspected non-conformances
WI-3043 Isocyanate and Resing HandlingWI-3039 Nitrogen BlanketingWI-3044 Resin Agitation TotesWI-5003 Cup TestWI-5006 Ratio CheckWI-5016 Gel Time TestWI-5002 Process InspectionWI-3001 Cutting Modules to Length and WeighingWI-3009 Drilling Modules – Standard HolesWI-5005 Physical and Dimensional InspectionWI-5004 Marking, Drill Hole, Slot InspectionWI-5007 Module DispositionWI-7003 Transfer of ModulesWI-7004 Order PreparationWI-3010 Packaging and Shipping PolesWI-3045 Cutting Poles to Length & Top CapsWI-3042 Custom DrillingWI-3014 Preparing Module & Pole ID TagWI-5027 Shipment Inspection
Incidents of known or suspected product or process non-conformances
may arise or be identified during the implementation of any of the activities identified
below (blue boxes). The respective controls, responsibilities, and
authority are detailed in the applicableWork Instructions (red text) identified under each of the individual scenarios
4.2.4 Control of Records
As applicable:Inspection Labels
On Hold – FAIL Tag (F-5004)NCR – Quarantine Tag (F-5011)Customer Notification/Warranty IssueCustomer-specific Requirements (Type 1 and Type 2 Non-nonconformance)
Determine disposition AuthorityQuality Lab Technician
per applicable Work Instruction assesses suspected or identified non-conforming materials/products to determine the Disposition authority
Type 1 Authority: The CompanyType 2 Authority: Customer
Go to A
Laboratory/Finished Product Testing
Quality Assurance Personnel identify & segregate known or suspected non-
conformances
WI-3040 Preparing Test Specimens from ModulesWI-5000 Flex Strength & Modules TestWI-5001 Interlaminar Shear Strength Testing of Tubular Composite SamplesWI-5008 Density, Void Content and Glass Content Test
See CSR…...Type 1 and Type 2
Processing Non-conformancesQuality Lab Technician
per applicable Work Instruction1) Implements Customer-defined dispositioning instructions or2) Determines & assigns disposition of one of the following:
- Return to Source - Scrap - 3rd Party Sort - Rework/reuse - Send to Lab for testing - Hold - Customer/Internal Waiver
3) communicates disposition status as applicable to ensure that customers are promptly informed of issues which might impact them (Supply Chain Coordinator notifies customer of any actual or potential supplier issues, or potential supply or capacity issues and Q.A. Manager notifies customer of any actual or potential non-conforming product which may have been shipped)4) maintains records of the nature of all nonconformities, (including “suspected nonconformities” which are subsequently approved, and any actions taken, including concessions/waivers obtained)
Customer to Disposition?
Customercommunicates
disposition status and required actions, as applicable
Yes
Nonconformance Monitoring RecordsCustomer Waiver
Disposition Labels, as appropriate:F-5015 Engineering Test LabelF-5021 Lab Sample LabelF-5004 On HOLD/FAIL TagF-5010 PASS TagF-5011 Do Not use/Hold/NCRF-5031 Interim PASS (Orange)
Customer communication
No
Non-conformance Type
ISO 9001
Customer-specifics
This printed document is an UNCONTROLLED COPY - Check B.O.S. to verify validity prior to use Date printed: Saturday, July 12, 2008
Patricia Ravanello - Management Systems SOP-0012 Control of Non-Conforming Product and Materials, Revision: 0 Page: 1 of 3
As applicable:Nonconformance ReportCustomer Waiver
Disposition Labels, as appropriate:F-5015 Engineering Test LabelF-5021 Lab Sample LabelF-5004 On HOLD/FAIL TagF-5010 PASS Tag
4.2.4 Control of Records8.3.4 Customer Waiver
4.2.4 Control of Records8.5.2 Corrective Action
7.1.4 Change Control8.3.2 Control of Reworked Product8.5.2 Rejected Product Test/Analysis
Repair/Rework
Respective Responsible Party takes action to:eliminate the detected non-conformityauthorize its use, release or acceptance, under concession by a relevant authority, and where applicable by the customer, orpreclude its original intended use or application
and initiates corrective action per SOP-0000 Corrective and Preventive Action and Continual Improvement and/or the applicable
Work Instruction as identified below, ensuring that records of the results of action taken are maintained
Customer/Supplier/Internal Waiver
Quality Assurance ensures that:
Customer Interim Authorization is obtained prior to further processing whenever the product or
process is different from that which is currently approved and that records are maintained of
the expiration date and quantity authorized per
SOP-0011 Change ControlWI-5____ Processing Engineering and Document Change Requests
Responsible party(per applicable W.I.)
identifies instructions for re-workidentifies re-inspection requirements to ensure effectiveness of corrective actionensures that the above is accessible and utilized by the appropriate personnel.WI-_____ Repair/Rework Management
Go To B
Design Change
SOP-0011 Change Control –Product, Process, SourceWI-7___ Management of Obsolete Material
Scrap/Disposal
WI-_____ Processing of Defects WI-______ Quarantine Area ManagementWI-5021 Safe Handling of Chemicals
Purge
WI-_____ Processing of Defects
Purging ofRaw MaterialsIn processFinished Product
Return to Source
WI-____ Processing of Defects WI-______ Quarantine Area Management
A
SOP-0000 Control of Non-conforming Product & Materials
- See respective output of processes (Work Instructions) identified below
This printed document is an UNCONTROLLED COPY - Check B.O.S. to verify validity prior to use Date printed: Saturday, July 12, 2008
Patricia Ravanello - Management Systems SOP-0012 Control of Non-Conforming Product and Materials, Revision: 0 Page: 2 of 3
Metrics DASHBOARDNon-conformance Monitoring Records
Rework RecordsScrap RecordsRepair RecordsSpill RecordsSupplier PPM
SOP-0000 Control of Non-conforming Product & Materials
B
End
Department Managers monitor and assess the nature and frequency of non-
conformances per SOP-0000 Monitoring, Measurement and Analysis
and report analysis and conclusions to Senior Management per
SOP-0000 Business Planning and Management Review1) to verify the suitability and effectiveness of the
Business Operating System,2) to monitor progress toward objectives3) to assess the need for additional resources, and
4) to identify or evaluate opportunities for continual improvement
- Management Review Meeting Minutes (Actions/Responsibilities/Timing)
- Resource Requirements- Opportunities or recommendations for
continual improvement
This printed document is an UNCONTROLLED COPY - Check B.O.S. to verify validity prior to use Date printed: Saturday, July 12, 2008
Patricia Ravanello - Management Systems SOP-0012 Control of Non-Conforming Product and Materials, Revision: 0 Page: 3 of 3