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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 applicable Work Instructions (red text) identified under each of the individual scenarios
5.2 Customer Focus 7.2.3 Customer Communication 7.4.3 Verification of Purchased Product 7.5.5 Preservation of Product 7.5.3 Identification & Traceability 8.3 Control of Non-conforming Product 8.3.1 Control of Non-conforming Product - Supplemental 8.3.3 Customer Information 4.2 Quality Requirements 4.6 Periodic Re-qualification 4.16 Customer Feedback
ISO 9001
Customerspecifics
Process/ Customer / Health & Safety Audits, Materials Management & Housekeeping
External Returns
Quality Assurance Department upon notification from Supplier, initiates action to trace, identify & segregate suspect/nonconforming materials
WI-____ Processing of Defects
Receiver/Quality Assurance identify & segregate suspect or non-conforming materials during inspection of incoming material or supplier qualification
WI-7001 Receiving Inspection of Raw Materials WI-7000 Bulk Tanker Offloading WI-5011 Testing Version Density WI-5012 Testing Version Pot Life WI-5013 Testing Version Viscosity WI-5014 Testing Isocyanates WI-5015 Testing Version Resin WI-5018 Receiving Inspection of Fibreglass
Production and/or Quality Assurance Personnel identify & segregate known or suspected nonconformances
WI-3043 Isocyanate and Resing Handling WI-3039 Nitrogen Blanketing WI-3044 Resin Agitation Totes WI-5003 Cup Test WI-5006 Ratio Check WI-5016 Gel Time Test WI-5002 Process Inspection WI-3001 Cutting Modules to Length and Weighing WI-3009 Drilling Modules Standard Holes WI-5005 Physical and Dimensional Inspection WI-5004 Marking, Drill Hole, Slot Inspection WI-5007 Module Disposition WI-7003 Transfer of Modules WI-7004 Order Preparation WI-3010 Packaging and Shipping Poles WI-3045 Cutting Poles to Length & Top Caps WI-3042 Custom Drilling WI-3014 Preparing Module & Pole ID Tag WI-5027 Shipment Inspection
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 Audit WI-____ Health & Safety Audit WI-5021 Safe Handling of Chemicals WI-7002 Handling and Storage of Raw Materials
Customer returns nonconforming product or notifies The Company of Warranty issues resulting in known or suspect Nonconformances
Customer Communication Customer Corrective Action Request
Engineering Engineering Design change results in obsolete materials which must be identified and segregated SOP-0011 Change Control Product, Process, Sourcing
Annual Validation Testing Respective Test/ Audit results in identification of nonconforming product Per Quality Inspection and Test Plan (QITP) Floor Plan Hold Area, Quarantine Area, Scrap Area Outdoor Storage Plan
As applicable:
Inspection Labels
On Hold FAIL Tag (F-5004) NCR Quarantine Tag (F-5011) Customer Notification/Warranty Issue Customer-specific Requirements (Type 1 and Type 2 Nonnonconformance)
No
Customer to Disposition?
Customer communication
Yes
Processing Non-conformances
Quality Lab Technician per applicable Work Instruction
1) Implements Customer-defined dispositioning instructions or 2) 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 Nonconformance Monitoring Records 3) communicates disposition status as applicable to ensure that customers are promptly Customer Waiver Disposition Labels, as appropriate: informed of issues which might impact them (Supply Chain Coordinator notifies F-5015 Engineering Test Label customer of any actual or potential supplier issues, or potential supply or capacity issues F-5021 Lab Sample Label and Q.A. Manager notifies customer of any actual or potential non-conforming product F-5004 On HOLD/FAIL Tag which may have been shipped) F-5010 PASS Tag 4) maintains records of the nature of all nonconformities, F-5011 Do Not use/Hold/NCR (including suspected nonconformities which are F-5031 Interim PASS (Orange) subsequently approved, and any actions taken, including concessions/waivers obtained)
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4.2.4 Control of Records 8.5.2 Corrective Action
Respective Responsible Party takes action to: eliminate the detected non-conformity authorize its use, release or acceptance, under concession by a relevant authority, and where applicable by the customer, or preclude 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
- See respective output of processes (Work Instructions) identified below
7.1.4 Change Control 8.3.2 Control of Reworked Product 8.5.2 Rejected Product Test/Analysis
Repair/Rework
Scrap/Disposal
Return to Source
Design Change
Purge
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 Control WI-5____ Processing Engineering and Document Change Requests
Responsible party (per applicable W.I.) identifies instructions for re-work identifies re-inspection requirements to ensure effectiveness of corrective action ensures that the above is accessible and utilized by the appropriate personnel. WI-_____ Repair/Rework Management
WI-_____ Processing of Defects WI-______ Quarantine Area Management WI-5021 Safe Handling of Chemicals
SOP-0011 Change Control Product, Process, Source WI-7___ Management of Obsolete Material
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Metrics DASHBOARD Non-conformance Monitoring Records Rework Records Scrap Records Repair Records Spill Records Supplier PPM
Department Managers monitor and assess the nature and frequency of nonconformances per SOP-0000 Monitoring, Measurement and Analysis and report analysis and conclusions to Senior Management per SOP-0000 Business Planning and Management Review 1) to verify the suitability and effectiveness of the Business Operating System, 2) to monitor progress toward objectives 3) 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
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