SBS - The best value in QMS software

Risk Management - To what extent is Risk Management required by AS9100?

B

Big Jim

Super Moderator
#11
#11
Do the production documents include what was determined to mitigate the risk? In other words, when risk was identified at the quote stage, did that get translated into specific things the workers are told to do that would mitigate risk?

After risk assessment, did someone figure out what was necessary to control the risk throughout product realization, and did that result in specifications or instructions being modified?

If that is happening, I would agree with your management that the workers need not worry about risk, as someone before them did and included what was needed into production planning.

If you are saying that nothing is being done about risk other than identifying it, I would agree with you that it is inadequate.
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
D

dwend

#12
#12
Hello,

I was going to open up a new thread on this forum but see that it would be helpful to just jump in on this one as I believe my questions/comments will be useful to the OP.
We just went through our AS9100C Stage 2 (we are B now) and received a NCR for failure to implement risk throughout product realization (not totally surprised about this by the way). During the audit our CB said they have written up 9 out of the 10 companies they have done a 9100C in the past year. We had a pretty decent form/process setup for risk management on quoting/planning/contact etc but lacked implementation in other areas of the product realization process. He specifically cited "organization" as part of the 7.1.2. We had a decent approach but not to the overall organization as it effected product (includes HR, purchasing, etc.) He pointed to the SCMH handbook on IAQG as an example of proper risk management. I had used the slides extensively in our prep but our organization was a little reluctant to get into more risk details but this result will propel us forward. I raise all of this for the following:
1) To let others know that one or two flow maps or a blurb in a Quality Manual might not be sufficient for some CB's, particularly as time moves on. This requirement will only get more involved as people look around and see what is required.
2) Ping the community to see what others are experiencing in their 9100C registration audits.

I suspect that our CB was a little more discriminating on this subject than some but we welcomed the opportunity for improvement and I was sort of glad to see it identified so we can get everyone else on board. It really helps the business side to identify, assess, and mitigate risks in all facets of the organization.:thanx:
 
R

Rickser

#13
#13
We focused on the product and those things that could go wrong with it. We also do a risk analysis and mitigation when replying to a request for proposal. Our basic approach is: if it doesn't apply to the product, it then falls into some other area outside of AS9100 requirements. We will see how this works as as our first audit is within two months.
 
D

dbaca0903

#14
#14
Rickser said:
We focused on the product and those things that could go wrong with it. We also do a risk analysis and mitigation when replying to a request for proposal. Our basic approach is: if it doesn't apply to the product, it then falls into some other area outside of AS9100 requirements. We will see how this works as as our first audit is within two months.
Click to expand...
Rickser,
How did your approach pan out? At my company, we try to take that approach with the whole standard. Our auditor doesn't seem to like our ways too much.
 
J

Jan T

#15
#15
We just had our stage 2 certification audit. The auditor dinged us for not having risk management (FMEA) for ALL QMS processes. I.e. receiving, QC etc. We had done them for the production (plating) of parts and calibration, doc control, CAPA, etc.
 
A

AndyN

Moved On
#16
#16
Jan T said:
We just had our stage 2 certification audit. The auditor dinged us for not having risk management (FMEA) for ALL QMS processes. I.e. receiving, QC etc. We had done them for the production (plating) of parts and calibration, doc control, CAPA, etc.
Click to expand...
Did you SAY (in your qms) you would have an FMEA for all processes?
 
B

Big Jim

Super Moderator
#17
#17
Jan T said:
We just had our stage 2 certification audit. The auditor dinged us for not having risk management (FMEA) for ALL QMS processes. I.e. receiving, QC etc. We had done them for the production (plating) of parts and calibration, doc control, CAPA, etc.
Click to expand...
Unless you said you would, the auditor is making up his own rules and you should hold him accountable.
 
J

Joy

#18
#18
"The organization shall establish, implement and maintain a process for managing risk to the achievement of applicable requirements, that includes as appropriate to the organization and the product"

So for meeting applicable requirements, if these processes have any risk then you need to have a process to manage those risks.The standard does not say that it need to be FMEA.As my friends have already mentioned that if you mentioned that you will establish FMEA for all processes, you need to respect that.Else the auditor will have onus to establish and convince the probable risks from those processes for meeting applicable requirements to raise NCR.
 

Attachments

You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
T Biological Evaluation (10993) & Risk Management ISO 14971 - Medical Device Risk Management 7
D Cybersecurity and Risk Management: Loss of confidentiality IEC 62304 - Medical Device Software Life Cycle Processes 4
S Risk Management Review ISO 14971 - Medical Device Risk Management 4
S Risk Management and other Files ISO 14971 - Medical Device Risk Management 8
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
A 21 CFR 820 - Risk Management - Looking for some guidance US Food and Drug Administration (FDA) 3
Sravan Manchikanti Software Risk Management & probability of occurrence as per IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
T How do you define your Hazards? <a Risk Management discussion> ISO 14971 - Medical Device Risk Management 16
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B ATP 5-19 "Risk Management" Misc. Quality Assurance and Business Systems Related Topics 2
N Risk Management besides mandated FDA requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Identifying Hazards - Risk management process ISO 14971 - Medical Device Risk Management 6
R Risk Management in the Medical Device Industry ISO 14971 - Medical Device Risk Management 4
F Linking an ISO 31000 Risk management SOP to ISO 17025 ISO 17025 related Discussions 2
Ronen E The unbearable insensitivity of risk management language Other Medical Device and Orthopedic Related Topics 1
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
M Risk/Benefit vs. benefit-risk - Revising an SOP covering Risk Management with the MDR in mind EU Medical Device Regulations 10
A Defining Expected Service Life in Risk Management File Reliability Analysis - Predictions, Testing and Standards 5
R Linking the Processes of Continual Improvement, Change Management, Risk Management, Action Planning, etc? Preventive Action and Continuous Improvement 5
D Risk management according to ISO 14971 - When to document risk controls? ISO 14971 - Medical Device Risk Management 10
J Software for Techfiles and Risk management ISO 14971 - Medical Device Risk Management 1
M Informational ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 6
M Medical Device News ISO TC 210 IEC SC 62A JWG 1 Medical device risk management – São Paulo meeting 2019 Medical Device and FDA Regulations and Standards News 0
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
M Informational ISO TC 210 JWG 1 meeting in São Paulo – Revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management Medical Device and FDA Regulations and Standards News 0
T Risk Management Report as per MDR Requirements EU Medical Device Regulations 4
S Medical Device Cybersecurity Risk Management File ISO 14971 - Medical Device Risk Management 2
M Medical Device News Health Canada Notice of intent: Strengthening the post-market surveillance and risk management Canada Medical Device Regulations 1
Q Evidence of precautions (clinical evaluation report, risk management report) EU Medical Device Regulations 6
Q Risk / benefit Analysis in Risk Management Report CE Marking (Conformité Européene) / CB Scheme 12
A How to view supplier APQP timeline and do risk management APQP and PPAP 4
O Medical Device EMC Risk Management CE Marking (Conformité Européene) / CB Scheme 4
S ISO 13485:2016 - How I can integrate a risk management approach in our SOPs ISO 13485:2016 - Medical Device Quality Management Systems 1
B Time necessary for all Risk Management activities ISO 14971 - Medical Device Risk Management 2
W Virtual Manufacturer and Risk Management ISO 14971 - Medical Device Risk Management 3
O CQE Handbook - Missing Section VII - Risk Management Misc. Quality Assurance and Business Systems Related Topics 1
F Medical Device HACCP (Hazard Analysis and Critical Control Point) Risk Management ISO 14971 - Medical Device Risk Management 2
J Differences between a Risk Management Plan vs. Production Part Approval Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Free Risk Management Webinar - Design for Quality - May 2017 Risk Management Principles and Generic Guidelines 1
J Will this fulfill the AS9100D Risk Management Requirement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
A Including all Processes in Risk Management - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 8
F Risk Management vs. FMEA ISO 14971 - Medical Device Risk Management 11
T Using Risk Management in ISO 10993 - Medical Device Accessory 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q Risk Management - Additional Process in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom