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Work Instruction Template
Quality System Work Instruction
10-10-0901: QCS Nonconformance Process
rev-14a00 - Approved by: QMR
WI 10-10-0901_14a00 UNCONTROLLED IF PRINTED page 3 of 4
Assign MRB Case Team
Identify required case team
Using online QCS / 9.0 Nonconformance / Open Tab
a) Evaluate Open Nonconformance Cases
- Select & Review Individual Cases
- update section “Problem Identification”
contact initiator if additional information is required
fields: title, description, type, code, source
field: priority set appropriately
b) Assign MRB case team
- update section “ Assign Material Review Board”
field: MRB Member standard core members
field: Othertemporary members with knowledge of problem / resolution
c) Save
MRB Team
Analysis, Actions & Disposition
Using online QCS / 9.0 Nonconformance / Open Tab
a) Analysis
- select case, view details
- update section “Disposition” with findings
field: Problem definition (restate & clarify)
field: Investigation Results ( team findings)
- update section “Attachments”
attach supporting documents ( lab-spec, analysis, other, .)
- Save
b) Disposition
Determine disposition based on analysis
- Accept: conforming / no actions
- Rework: product / asset is to be isolated, reworked & re-inspected
or associated documentation is to be revised
- Reclassified: product / asset reclassified to another application
- Scrap: product /asset is rejected, isolated, and scrapped
or written documents are obsoleted
c) C&P Actions
- update section “ Corrective & Preventive Actions”
select “Create C&P Actions” ( multiple if required)
ref: 10-10-1001 QCS- Corrective and Preventive Actions
d) Close
- Update field: Recommended Action /section Disposition
with appropriate Disposition (accept, rework, reclassified, scrap)
- Save
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