SBS - The Best Value in QMS software

Criteria and when to carry out Setup Approval

Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
Ron Rompen

Ron Rompen

Trusted Information Resource
#2
#2
Without knowing your processes and customer requirements, it is difficult to provide a meaningful answer to your question.

In general, unless otherwise specified by your customer, the criteria for performing setup inspection is something that YOU need to determine, based on your manufacturing processes and the risk(s) of failure that you identify.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
P Burst Test Acceptability Criteria ISO 13485:2016 - Medical Device Quality Management Systems 2
H Medical Device Label Acceptance Criteria Manufacturing and Related Processes 4
M Testing criteria - where to place Design and Development of Products and Processes 2
D What are the acceptance criteria/requirements for Stability Study? General Measurement Device and Calibration Topics 7
L Gage R&R TMV Acceptance Criteria Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
S On-time delivery CRITERIA AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
R Clinical accuracy and repeatability of IR(infrared) thermometer, no maximum error criteria is recommended in ISO Other Medical Device Related Standards 11
M ISO 14971:2019: Criteria for overall residual risk ISO 14971 - Medical Device Risk Management 11
O GR&R Acceptance Criteria Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Shore A hardness Tester Acceptance Criteria Standard Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
lanley liao Purchase Acceptance Criteria - Tensile testing Oil and Gas Industry Standards and Regulations 2
M Audit Criteria Training Materials Internal Auditing 1
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
B GM GP-12 Exit Criteria - Additional Safe Launch Inspection - (Also see GM1927-28 ) Customer and Company Specific Requirements 2
B AS9100 8.4.1 Supplier Selection/Evaluation criteria and reevaluations AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
I Mother bobbin final inspection criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
R Procedure, Frequency and Acceptance Criteria for Replicate, Recalibration, Before-After and Intermediate Checks ISO 17025 related Discussions 8
P Design FMEA - Detection Rating criteria ISO 14971 - Medical Device Risk Management 3
J Criteria Matrix To Initiate An A3 or 8D ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
qualprod Best criteria to measure Corrective Action effectiveness - Poor Maintenance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ASTM F2924-14 /ASTM F3001 - Room temperature classification criteria Other US Medical Device Regulations 1
M Supplier selection criteria - Medical devices ISO 13485:2016 - Medical Device Quality Management Systems 3
qualprod Criteria to raise a Nonconformance based on KPI values ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 39
V What is the criteria to cite an good documentation practices observation as an data integrity related issue US Food and Drug Administration (FDA) 6
S Acceptance criteria for gauges General Measurement Device and Calibration Topics 8
M Characterization Testing - NO acceptance criteria, no minimum performance requirement Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
J AIAG PPAP: 2.2.11.3 Acceptance Criteria for Initial Study (page 9, 4th edition) APQP and PPAP 1
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
Z UDI assignment Criteria Software IVDR Other Medical Device Regulations World-Wide 0
Ashok sunder What are the criteria for setting a target KPI value against a quality objective? Benchmarking 7
qualprod Criteria for print shop - How do you consider the cycle time in a print shop? Lean in Manufacturing and Service Industries 21
eule del ayre IATF 16949 / ISO 9001:2015 audit criteria IATF 16949 - Automotive Quality Systems Standard 17
GStough Auditing Against Criteria Unfamiliar to Auditee - Yea or Nay? General Auditing Discussions 11
M Internal Audit Assessment Criteria - ISO 13485:2016 Internal Auditing 21
S Agreement for allowance for visual criteria after submission APQP and PPAP 1
V Process and Internal Audit Criteria matrix wanted Internal Auditing 8
I Writing a Cosmetic Criteria for Switches Document Control Systems, Procedures, Forms and Templates 1
M Example ISO 14971 policy and risk criteria ISO 14971 - Medical Device Risk Management 0
D How to set equipment calibration/verification criteria General Measurement Device and Calibration Topics 1
A Operating criteria for production processes - ISO 14001 Cl. 8.1 ISO 14001:2015 Specific Discussions 3
B The most important criteria of IEC 60601-1 medical devices safety IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P Supplier (Vendor) Evaluation Criteria - IATF 16949 Cl. 8.4.1.2 IATF 16949 - Automotive Quality Systems Standard 1
H CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4 CE Marking (Conformité Européene) / CB Scheme 9
K Internal Audit Scope and Criteria Internal Auditing 9
K ISO 9001:2015 clause 9.2.2 a. - Define the audit criteria and scope Internal Auditing 2
Q Criteria to pursue an opportunity ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
V Periodic review criteria for reviewing/updating SOPs US Food and Drug Administration (FDA) 1
B IATF 16949 Cl. 8.6.6 - Acceptance Criteria - Zero Defects Attribute Data Sampling IATF 16949 - Automotive Quality Systems Standard 2

Similar threads

Top Bottom