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Material Changes - To keep questions and answers as records?

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B When to file a Preamendment Device - Material Changes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q A problem with material being used in a PPAP - Material Changes APQP and PPAP 4
H Customer Notification of Transfer, Material and/or Other Changes QS-9000 - American Automotive Manufacturers Standard 2
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
S Advice on how to reduce overhead of handling non-conforming material Nonconformance and Corrective Action 7
R AS9102 FAI Change in Material / Process Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Predicate Material 510(k) US Food and Drug Administration (FDA) 1
S Predicate Material 510(k) Medical Device and FDA Regulations and Standards News 3
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E Record Retention - Raw Material (Steel Certs) Records and Data - Quality, Legal and Other Evidence 3
M Documents to be included in 1.3 Material check in PPA report APQP and PPAP 4
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
M Material incoming to the production process reflected in PFMEA FMEA and Control Plans 9
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
Q Change the shape of the raw material FAI AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Regrind Material in Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 1
Anonymous16-2 Dietary Supplement Raw Material/Component Storage and Production Manufacturing and Related Processes 1
H Expired packaging material - Expired unused Tyvek pouches Other Medical Device and Orthopedic Related Topics 2
A Design History File - Not ready to share the design drawings or Bill of Material US Food and Drug Administration (FDA) 2
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
D List A IVD - Change to material supplier EU Medical Device Regulations 3
Skooma Deburring and Tolerances - Is there a Standard for deburring or removing material? Manufacturing and Related Processes 3
D Can PFMEA be used in disposition of NC material? ISO 14971 - Medical Device Risk Management 4
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 5
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
L AS5553 Clause 3.1.7 e "Control packaging material ..................reused" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
J Raw material certificates - CC - Safety products - Sheet metal stamping IATF 16949 - Automotive Quality Systems Standard 1
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
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C Material from outside CER evaluation period CE Marking (Conformité Européene) / CB Scheme 8
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
6 Management of SDS and Hazardous Material Occupational Health & Safety Management Standards 2
L ASQ CBA biomedical auditor - CBA primer material is enough to study? ISO 13485:2016 - Medical Device Quality Management Systems 6
DuncanGibbons Are there any aerospace specific requirements for material resource planning? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Was Just told we could ONLY buy material for AS9100 customers if the DISTRIBUTION house is AS9100 / AS9120 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
C Clean room injection molding, raw material mixing requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
C Raw material Mixing / Preparation for clean room class C injection molding Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
P GM TWO (Temporary Work Order) - Is there a specific GM format for the TWO# to be sent with the material? IATF 16949 - Automotive Quality Systems Standard 1
R ASQ reference material clarification - Spiral bound materials allowed in ASQ Exam? Professional Certifications and Degrees 1
Manix Supplied Steel Material Testing Norms and Requirements Supplier Quality Assurance and other Supplier Issues 1
R Material safety data sheet (MSDS) related clause in IATF 16949 manual IATF 16949 - Automotive Quality Systems Standard 17
K Interpretation of significant change - material change Canada Medical Device Regulations 3
M Raw stock material testing discrepancy using an XRF (x-ray fluorescence) analyzer Manufacturing and Related Processes 7
W Scope of MRB (Material Review Board) Responsibilities Misc. Quality Assurance and Business Systems Related Topics 5
M Conformal Coating & AS9102 - Is conformal coating material a COTS part AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Maximum Height for the stored material or stock materials Occupational Health & Safety Management Standards 1

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