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John C. Abnet Must COPQ always be quantified as a monetary ($) amount? IATF 16949 - Automotive Quality Systems Standard 2
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
Stoic Manual soldering processes - 100% verifiable, or always requiring validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
qualprod Always one root cause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 35
M User manual / instructions for use for class II device always required? Medical Device and FDA Regulations and Standards News 3
K Is Mold qualification / process validation always required? Manufacturing and Related Processes 7
D Is formulative testing always required IEC 62366 - Medical Device Usability Engineering 1
K Do Forms and Templates ALWAYS become Records? Records and Data - Quality, Legal and Other Evidence 4
N Witty (snarky?) Responses: Always have one prepared Coffee Break and Water Cooler Discussions 25
howste AS9100 Rev D Clause 10.2 - Is Cause always required? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 39
M Does there always have to be a "correction?" Problem Solving, Root Cause Fault and Failure Analysis 16
N Do new requirements always need a validation? IEC 62304 - Medical Device Software Life Cycle Processes 5
M FDA 21 CFR 820.250 - Does "valid statistical" always mean math? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B Is SPC data For Special Characteristics always required? TS 16949 clause 8.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Is Notification of the Test Laboratory always necessary for Supplier Changes? IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
Jim Wynne APQP, or Why Things Always Go Wrong APQP and PPAP 0
R Always Internal Audit all Line Items of applicable FDA Regulations? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
O Is SPC (Statistical Process Control) always required? Statistical Analysis Tools, Techniques and SPC 4
R Problems with Supplier - Always with 100% Sorting - No Corrective Actions Supplier Quality Assurance and other Supplier Issues 22
P CSR (Customer Specific Requirements) in TS 16949 Audits - Always required? IATF 16949 - Automotive Quality Systems Standard 27
A PFMEA a 'Live' Document and should always have Open Actions FMEA and Control Plans 15
A In-Process Inspection Results ALWAYS With PPAP? APQP and PPAP 8
G AS9100C Upgrade Audit - 4.1c&f - The "Always" NCR? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
S Ppk & Cpk - Within Subgroup Variation is always smaller than Total Variation Capability, Accuracy and Stability - Processes, Machines, etc. 18
M Is a Significant Aspect always a Significant Aspect? Miscellaneous Environmental Standards and EMS Related Discussions 13
Z Isn't 'Improvement Always' a meaningful work? Misc. Quality Assurance and Business Systems Related Topics 3
Q CAPA (Corrective Action and Preventive Action) after Correction always? Nonconformance and Corrective Action 10
Q Corrective Action - Disposition always Correction? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Scrap + Replacement always? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Why Cp should always be greater than Cpk Capability, Accuracy and Stability - Processes, Machines, etc. 7
P Must Key Product/Process Characteristics (KPC's) always be variables? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
R Does IVD 510k application always goes to pre-IDE and IDE process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Why is the first bid quotation always rejected Coffee Break and Water Cooler Discussions 7
W Internal Auditor always on duty? Internal Auditing 8
Q Purchasing mapped if not always participate? Is Purchasing a Support System? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Is Six Sigma always Green? The Impact of Six Sigma Six Sigma 8
E Correction and Corrective Action - ALWAYS DOCUMENT BOTH Nonconformance and Corrective Action 13
M Special Cause Variation ALWAYS human related? Six Sigma 6
G Is Medical Grade Gas always a drug? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
M Do nonconformances always result in corrective action ISO 13485:2016 - Medical Device Quality Management Systems 67
L FMEA - Should a severity of 9 or 10 be always followed by recommended actions? FMEA and Control Plans 2
Marc Acronym FORD Acronyms (aka 'Initialisms' - Not Always True Acronyms) List Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 17
S Welding - Is welding always a special process per ISO9001:2000 Clause 7.5.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
Icy Mountain Answering a Finding that is Not? Work instructions are not always followed IATF 16949 - Automotive Quality Systems Standard 9
Jim Wynne Another reason why things always go wrong Coffee Break and Water Cooler Discussions 14
A Customer is always right Coffee Break and Water Cooler Discussions 34
H Does a Nonconforming Material Report always generate a Corrective Action? Nonconformance and Corrective Action 9
H 7.6 investigation - Do most operations always record the gage# on all test reports? Records and Data - Quality, Legal and Other Evidence 8
Claes Gefvenberg Is the customer always right? Personally, I strongly disagree. Philosophy, Gurus, Innovation and Evolution 47
D Production before Quality - Is the Customer Always Right? Misc. Quality Assurance and Business Systems Related Topics 9

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