SBS - The Best Value in QMS software

What are some defined requirements for determining potential noncon & causes?

R

Raptorwild

#1
#1
Can anyone give some examples of "Defined requirements for determining potential nonconformities and their causes"?

Is the standard asking for actual instructions to do this and do they need to be documented in the Preventive action procedure?

Thanks
Paula:bigwave:
 
Popular whitepapers from DISCUS
Elsmar Forum Sponsor
B

Bill Ryan - 2007

#3
#3
I don't know if I'm fully awake yet this morning but Paula's first line just "screams" PFMEA to me. As to the second question, I suppose a blurb mentioning PFMEA and any other risk analysis methodology employed could be in the PA procedure.

As I reread this, it came to me that a Feasibility Analysis should also be included which would incorporate more of the "service" departments into the PA process.
 
Last edited by a moderator:
C

cncmarine

#4
#4
Good Stuff

The most important thing to remember is that the system needs to be documented and have defined requirements for closure.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S No Process Defined to Capture the Special Requirements of Customers Problem Solving, Root Cause Fault and Failure Analysis 10
P Defined Records Retention Time Of Customer/Regulatory Requirements Records and Data - Quality, Legal and Other Evidence 4
apestate Poorly Defined Product Requirements - ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
apestate Integrity in reporting, and Poorly defined Tolerances and Requirements Records and Data - Quality, Legal and Other Evidence 4
J 7.6.3.1 Internal Laboratory - Are "Technical requirements" defined somehow? IATF 16949 - Automotive Quality Systems Standard 2
L What is defined as a Laboratory? Supplier Laboratory Requirements - QS-9000 4.10.6 General Measurement Device and Calibration Topics 7
G Remote support - IATF allowed words defined? IATF 16949 - Automotive Quality Systems Standard 9
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
J Action Not defined in procedure - NC - Incoming inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
M Is there any pre-defined Control plan format/template acc. VDA? VDA Standards - Germany's Automotive Standards 1
C Design and implementation of process audits as defined within IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
T No Defined Shelf Life/Expiration Date - Disposable single-use, non-invasive, non-sterile Other Medical Device Regulations World-Wide 2
S How are Medical Device Components and Subassemblies defined? ISO 13485:2016 - Medical Device Quality Management Systems 1
Mikishots Definition Defined - Definition and meaning of "defined" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 10
E Defined Roles in Small Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
A Short Term vs. Long Term SPC Study - Where is Cp and Cpk Defined Statistical Analysis Tools, Techniques and SPC 8
P Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Review ISO 13485:2016 - Medical Device Quality Management Systems 7
J Measuring Leakage Currents with IEC 60601 defined Measurement Device (MD) IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
R Technical Files Sampling Rule defined in NBOG 2009-4 EU Medical Device Regulations 2
J What results need to be defined in IATF 16949 Clause 8.3.4 IATF 16949 - Automotive Quality Systems Standard 3
J Deformation specification not defined in print Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
S How others have defined "reaudits"? 21 CFR Part 820.22 Internal Auditing 1
R Property - What is defined as Property in ISO 14971 ISO 14971 - Medical Device Risk Management 4
C AS9100 Requirement Definition - Defined vs. Documented AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
X Are defined roles and responsibilities mandatory for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Root Cause of 'Supplier Evaluation Not defined' Nonconformance and Corrective Action 15
J Is painting considered a Special Process as defined by ISO 9001 7.5.2? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
sagai Preventive Action vs. Corrective Action as defined by 21CFR820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
A How is Segregation of Duties defined in the IT World? IEC 27001 - Information Security Management Systems (ISMS) 4
Q Must Support Processes have defined KPI's (Key Performance Indicators)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K What constitutes (is defined as) as a Medical Device? Other Medical Device and Orthopedic Related Topics 3
Chennaiite External Audit re-defined Imported Legacy Blogs 4
B Definition Diagnostic - Is "diagnostic" defined in the EU Medical Device Standards? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 10
H Document Control Defined? Determining what documents must be controlled ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
V QbD Approach - What are the "New Processes" to be "Defined / Introduced" US Food and Drug Administration (FDA) 6
kedarg6500 What is the meaning of "define/defined" in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
G How is a Medical Device defined in the EU? ISO 13485:2016 - Medical Device Quality Management Systems 2
Q Suspect Product: How can Suspect Product be defined? TS 16949 IATF 16949 - Automotive Quality Systems Standard 15
G SEI CMMI Dev v1.3 - Defined (ML2) and Managed (ML3) Process Areas Software Quality Assurance 1
T TS 16949 Internal Audit Effectiveness Defined Internal Auditing 5
V Definition Documented versus Defined Procedures Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
J Control of Outsourced Processes defined within the Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
I Does a QMS defined by the element-by-element approach meet the intent of 4.1a? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
T A confusing Non-conformity - No defined QMS processes intended for 'Management' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Defined intervals for review of quality system documents? Document Control Systems, Procedures, Forms and Templates 13
S Non-conformance regarding Lean Process - Lean Process is not defined ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
P Specified stages of design and development shall be defined - TS 16949 clause 7.3.4.1 IATF 16949 - Automotive Quality Systems Standard 4
M Common tools defined Funny Stuff - Jokes and Humour 3
C Measurement of Uncertainty ?as defined by the US Pharmacopeia? Measurement Uncertainty (MU) 9

Similar threads

Top Bottom