Risk Analysis 7.2.2.2 - How is Risk Analysis defined by auditors?

R

R-Moore

#1
#1
How is Risk Analysis defined by auditors?

To what extent should one take the risk analysis? During the up front contract review we look at the obvious, i.e. Liability issues, performance to schedules ...

Am I missing the point???

thanks in advance,
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
S

Sam

#2
#2
Risk Analysis an assessment of the organization's capacity and capability to effectively and efficiently provide the customer specific deliverable. The risk analysis should include program timing, resources, development costs and investments. Risk assessment should be undertaken to assess the potential for, and the effect of, possibel failures or faults in processes including the organization's direct suppliers.

IMO,sounds like the FMEA process to me.

Incidently, at the recent supplier auditor certification training, the only discussion pertaining to risk analysis was the completion of a "Turtle" diagram (for each process) which asks the questions; with what?, with who?, how many?, how?.

Cheers
 
R

R-Moore

#3
#3
Thank you Sam! I could not find a definition for Risk Analysis, hence I was not sure if we were addressing the basic requirements.

Thanks again for your help,

-bob
 
S

Sam

#5
#5
s_warin,
Think of the process as a "turtle shell" at the end of the 4 legs would be the questions; with what, with who, how many, how.
At the tail would be the customer input, at the head would be the process output that meets customer requirements.
When sketched on paper, the diagram should resemble the skeletel figure of a turtle.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
H Risk Analysis and Probability of Occurrence ISO 14971 - Medical Device Risk Management 3
B Risk analysis for defective measuring or measuring equipment out of calibration General Measurement Device and Calibration Topics 2
P Benefit risk analysis on pFMEA ISO 14971 - Medical Device Risk Management 9
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2
E Normal Condition Hazards in Risk Analysis ISO 14971 - Medical Device Risk Management 3
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
R ECG Risk Analysis Standards ISO 14971 - Medical Device Risk Management 2
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
M IATF 16949 (6.1.1 - Planning and Risk Analysis for a remote site) Process Maps, Process Mapping and Turtle Diagrams 5
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
M An example of risk analysis of class I MD ISO 14971 - Medical Device Risk Management 36
T Risk analysis of QMS software - Validating software we use for QMS ISO 13485:2016 - Medical Device Quality Management Systems 8
B Grouping of Products for Risk Analysis ISO 14971 - Medical Device Risk Management 9
A Risk-benefit Analysis - Hazard Analysis (HA) and FMEAs ISO 14971 - Medical Device Risk Management 18
R The difference b/w FMEA & Risk analysis as per iso 14971 ISO 14971 - Medical Device Risk Management 8
K Risk Analysis Updates due to complaints ISO 14971 - Medical Device Risk Management 10
S The Severity of a Medical Device Hazard - Risk Analysis Clarification ISO 14971 - Medical Device Risk Management 6
Ed Panek Transition to IEC 60601 4th Edition - Risk Analysis and test submissions CE Marking (Conformité Européene) / CB Scheme 2
S In a risk analysis, how can we tie mobile app security breach to ISO 14971? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Risk / benefit Analysis in Risk Management Report CE Marking (Conformité Européene) / CB Scheme 12
R IATF 16949 Clause 6.1.2.1 - Lessons Learned and Risk Analysis IATF 16949 - Automotive Quality Systems Standard 6
S Risk analysis 6.1 and contingency plans 6.1.2.3, are they related? IATF 16949 - Automotive Quality Systems Standard 26
B Software Class A - Lengthy further risk analysis IEC 62304 - Medical Device Software Life Cycle Processes 9
W Biocompatibility Risk Analysis for Clinical Practitioner 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F Risk Analysis of a Medical Device Accessory ISO 14971 - Medical Device Risk Management 4
S How we can use risk analysis for suppliers IATF 16949 - Automotive Quality Systems Standard 6
I Medical Device Software Risk Analysis ISO 14971 - Medical Device Risk Management 4
Q Risk Analysis - Same Risk Treatment for Context and Interested Parties ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Risk Analysis for COTS/OTS Risk Management Principles and Generic Guidelines 4
M IATF 16949 Cl. 8.7.1.4 - Risk analysis for decision making about rework IATF 16949 - Automotive Quality Systems Standard 2
E Risk Analysis - Events which may cause to Data Loss ISO 14971 - Medical Device Risk Management 12
W Risk Benefit Analysis - ISO 14971:2012 Requirements ISO 14971 - Medical Device Risk Management 27
F Medical Device HACCP (Hazard Analysis and Critical Control Point) Risk Management ISO 14971 - Medical Device Risk Management 2
Q Risk Tools in ISO 31010 - Root Cause Analysis vs. Cause-and-effect Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Organizing Risk Analysis and Controls for a New Medical Device (ISO 14971) ISO 14971 - Medical Device Risk Management 4
S Please review my Risk Analysis Table ISO 14971 - Medical Device Risk Management 13
K Risk Analysis and "Information for Safety" / Labeling ISO 14971 - Medical Device Risk Management 10
M Risk analysis - ISO/TS 16949 clause 7.2.2.2 IATF 16949 - Automotive Quality Systems Standard 2
C Help with Risk/Benefit Analysis Self-help Device for Diabetics ISO 14971 - Medical Device Risk Management 3
A FTA-Top/Down approach to Risk Analysis ISO 14971 - Medical Device Risk Management 2
A Industry best practice about Post-Market Surveillance and Risk Analysis ISO 14971 - Medical Device Risk Management 6
T Risk Analysis help for CE Marking Class I Medical Device ISO 14971 - Medical Device Risk Management 10
T Risk Analysis for moving manufacturing equipment ISO 14971 - Medical Device Risk Management 17
D Different kinds of Risk Analysis for various Hazards ISO 14971 - Medical Device Risk Management 3
L GHTF/SG3/N15R8 - Process Validation and Risk Analysis ISO 13485:2016 - Medical Device Quality Management Systems 4
R Risk Analysis of Class IIb Disinfectant ISO 14971 - Medical Device Risk Management 6
J Does anyone have an example of Risk-Benefit Analysis per ISO 14971? Other ISO and International Standards and European Regulations 2

Similar threads

Top Bottom