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Performing product audits in a manufacturing facility

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A SOP for performing Annual Product Reviews for Medical Device and Pharma Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
P For business performing PRODUCT DEVELOPMENT ONLY, what is best QMS for certification? Quality Manager and Management Related Issues 2
Geoff Cotton Performing a Delta Audit General Auditing Discussions 12
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
I Root Cause Analysis when someone simply stops performing a task? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
K ISO 17025:2017 clause 7.6.2 - Performing calibration of its own equipment shall evaluate the measurement uncertainty ISO 17025 related Discussions 6
H Question about implications of performing Firmware upgrade via MDDS - Medical Device Data Systems 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Justifications for not performing MSA (Measurement System Analysis) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
V Sequence of performing risk assessment: User_FMEA (User Errors) vs Design Inputs FMEA and Control Plans 1
A ISO 9001:2015 - How to apply 7.1.5 to an organization performing only design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Performing PQ on a Small (tabletop) Air Heat Treating Oven ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Thoughts on performing an ISO 9001:2015 Remote Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H Performing a TUS on a Furnace used at One Temperature - AMS2750-E AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 27
drgnrider EMR performing audits of EMS Miscellaneous Environmental Standards and EMS Related Discussions 13
C Performing an ISO 9001 based Supplier Audit - Multiple Supplier Facilities Supplier Quality Assurance and other Supplier Issues 4
D Performing a Gage R and R with No Specification Range Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
C Going Rate for Performing a Supplier Audit? Consultants and Consulting 1
B Performing MSA on Straightness of a Cylinder Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 13
C Performing a MSA as it relates to Calibration Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
J Performing a MSA on a new gauge using different parts Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
K Production Operators Performing GP12 (General Motors Containment) Customer and Company Specific Requirements 2
L How is the interaction physically happening while performing ANOVA GR&R? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
E Exam for Personnel performing Calibration General Measurement Device and Calibration Topics 7
B Performing a Gage R&R Study with Minitab 13 Using Minitab Software 5
M Requirements for Laboratories performing ASTM Tests Various Other Specifications, Standards, and related Requirements 4
J 5.15 or 6 Sigma? What multiplier to use when performing a Gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
D Severity or Occurrence? Performing an FMEA on Motorcycle Operation FMEA and Control Plans 9
K Performing PPAP Retroactively APQP and PPAP 8
H Proprietary Processes - How to Protect and still comply when performing an FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Performing Internal Calibrations - Dial gauges, micrometers, height gauges, calipers General Measurement Device and Calibration Topics 8
D External Parties performing Internal Audits? TS 16949 Clause 8.2.2 IATF 16949 - Automotive Quality Systems Standard 15
JoCam Budding Consultant: What to charge for performing a desktop study. Career and Occupation Discussions 10
Miner Upcoming article - Within-part variation when performing an R&R Imported Legacy Blogs 6
D Performing Internal Audit of our Accounts System Internal Auditing 4
S Performing Internal Audits as per Canada MDR GD 210 Internal Auditing 7
E Minimum data for performing an Anderson Darling Test Statistical Analysis Tools, Techniques and SPC 1
A Difficulties in performing MSA on Rockwell Hardness Tester Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 20
G Performing an Internal Audit on the Cost Estimating Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
6 Badly Performing Packaging Machines Manufacturing and Related Processes 1
D People Management - Managing an under performing subordinate Career and Occupation Discussions 15
A Competence for performing compliance audits - 4.5.2 Miscellaneous Environmental Standards and EMS Related Discussions 6
C New to performing internal audits - Looking for audit questions Internal Auditing 5
A Justification for not performing overseas supplier audit General Auditing Discussions 6
A Performing Ring Gage Calibration General Measurement Device and Calibration Topics 5
E Hypothesis Test - Determining if a second wash is worth performing Statistical Analysis Tools, Techniques and SPC 7
S Performing Investigation of used returned expired devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Guidance in Performing a 13485 Gap Analysis ISO 13485:2016 - Medical Device Quality Management Systems 8
Douglas E. Purdy Personnel performing specific assigned tasks shall be qualified - Interpretation IATF 16949 - Automotive Quality Systems Standard 6
F Clinical Audits to ISO 14155 - Performing audits of clinical affairs groups ISO 13485:2016 - Medical Device Quality Management Systems 4
T Non-conformity - Not performing Supplier Development on one specific supplier IATF 16949 - Automotive Quality Systems Standard 25

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