Periodic validation of raw material test reports (7.4.3)

K

kiwisfly

#1
#1
THIS CARRIES ON FROM ANOTHER THREAD:

I've seen a few successful approaches to validation of raw material test reports and even more attempts. Probably the most effective I've seen is a supplier who identifies their top 3 or 4 'raw material' suppliers and takes a quarterly sample of test certificates for independent validation. The independent test is done by a teaching laboratory so they have managed to keep the costs quite reasonable.

I have put 'raw material' in quotation marks as I understand some CRB's are taking a fairly broad view to what constitutes raw material. Some say validation is only required for material that has a material certificate, for example a mill certificate. But the clause refers to 'test reports' so this could equally apply glues and resins used for composite components or any other item that arrives with a test report.

Can any of the forum members shed any further light on the topic? It is something I get asked quite often.

Cheers

Chris
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
B

BadgerMan

#2
#2
We take a random sample of items accepted via C of C and send them out for independent verification of the material. The initial tendency was to only include “raw” material and metallic items but now we include purchased components and materials other than metals in our sampling. You are right in that you could (should?) consider things like adhesives and resins too.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
I Periodic Review of Process and Equipment Validation Qualification and Validation (including 21 CFR Part 11) 4
J Periodic review of Documents during management review Document Control Systems, Procedures, Forms and Templates 26
V Process revalidation periodic criteria Manufacturing and Related Processes 5
P 21 CFR 58 GLP Periodic Study Phase Inspection Report Other US Medical Device Regulations 0
V Is periodic-requalification relevant for laboratory instruments Qualification and Validation (including 21 CFR Part 11) 1
A TGA - Annual Report or Periodic Safety Update Report? Other Medical Device Regulations World-Wide 0
B SAP Audit trail Periodic Review EU Medical Device Regulations 2
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
D CSV - Periodic Review Qualification and Validation (including 21 CFR Part 11) 1
Marc Interesting Discussion The periodic table is 150 years old - March 2019 Coffee Break and Water Cooler Discussions 3
P Periodic Review - Deviations/incidents that are reviewed Qualification and Validation (including 21 CFR Part 11) 8
M FDA or CE requirements for periodic checks of data backups and retrievals EU Medical Device Regulations 4
T Regulation (EU) 2017/745 and PSUR (periodic safety update report) EU Medical Device Regulations 9
V Periodic review criteria for reviewing/updating SOPs US Food and Drug Administration (FDA) 1
P EU MDR and PSUR (Periodic Safety Update Report) EU Medical Device Regulations 44
V Periodic Audit Trail Review - Scope, Content & Frequency Qualification and Validation (including 21 CFR Part 11) 13
B IATF 16949 Cl. 8.5.1.5 - Requirement for Periodic Overhaul IATF 16949 - Automotive Quality Systems Standard 10
S How to document revisions after Periodic Review of documents ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
I Does ISO 13485 have a Periodic Document Review Requirement? ISO 13485:2016 - Medical Device Quality Management Systems 7
A Current Control Periodic Document Reviews - Process Updates in the FMEA FMEA and Control Plans 3
F Periodic Review Requirements for Software - Medical DeviceS Software Quality Assurance 2
T Periodic Quality Manual and Procedure Review Requirements General Auditing Discussions 5
S Is hiring a CB for certification and periodic audits an outsourced activity? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
V Where & How to Capture Details of Periodic Reviews of Change Control & CAPAs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
T Clause for Maintenance - Periodic Maintenance Activity (Oil change) Internal Auditing 4
C API Q1/ISO-TS 29001 Periodic Assessment of Stock Oil and Gas Industry Standards and Regulations 3
S Auditing our own activity - Periodic audit of our documentation Internal Auditing 11
B Can I Claim That Periodic Calibration is Not Required? ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Computerized System Periodic Review Requirement - Pharma Company Qualification and Validation (including 21 CFR Part 11) 7
R Periodic evaluation of suppliers - ISO 17025 4.6 Purchasing services and supplies ISO 17025 related Discussions 3
R Do Engineering Standards require periodic review? ISO 9001 4.2.4 (b) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
M Documents of External Origin - Periodic or annual verification of revision status ISO 13485:2016 - Medical Device Quality Management Systems 10
M Surface plates - Questioning the need for periodic calibration of surface plates General Measurement Device and Calibration Topics 12
R Periodic / Maintenance Audits Schedule ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Periodic Product Requalification Process IATF 16949 - Automotive Quality Systems Standard 1
tony wardle Periodic Evaluation of Legal Compliance - ISO 14001 - 4.5.2.1 - Legal Requirements ISO 14001:2015 Specific Discussions 22
K Review complete, no changes needed - When a Procedure is due for a periodic review? Document Control Systems, Procedures, Forms and Templates 10
T QP-5.6.0 - Management Review should be both periodic and continual Management Review Meetings and related Processes 14
S ISO 14001 - Periodic External Audit by Consultant Requirement? ISO 14001:2015 Specific Discussions 99
A Meeting the ISO 14001 Periodic Audits Requirement - Internal vs. External Auditing ISO 14001:2015 Specific Discussions 11
D ISO 9004 6.2.2.2 has listed "periodic refresher programs for people already trained" General Auditing Discussions 6
M What does the APQP manual mean by the term 'Periodic Requirements' FMEA and Control Plans 2
J Document Control NCR - Periodic Reviews Document Control Systems, Procedures, Forms and Templates 3
M Doubt about the element 15.3 (VDA) - Periodic cross-check and repeated inspections VDA Standards - Germany's Automotive Standards 3
A Has anyone implemented the Adobe Acrobat Sign Validation Pack to be 21 CFR Part 11 Compliant? ISO 13485:2016 - Medical Device Quality Management Systems 1
C Test Method Validation - ISO Standards Qualification and Validation (including 21 CFR Part 11) 1
J API Q1 - 5.7.1.5 - Validation of Processes for Production and Servicing Oil and Gas Industry Standards and Regulations 4
A Validation Plastic Injection Molding Process protocol ISO 13485:2016 - Medical Device Quality Management Systems 5
M Use of statistical techniques for Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 9
M Risk-based approach to Test Method Validation for Design Verification? US Medical Device Regulations 4

Similar threads

Top Bottom