Will this fulfill the AS9100D Risk Management Requirement

J

jmariscal90

#1
I am wondering if this will fulfill the AS9100D requirement of risk management.


Most of our risk assessment is done during the quote/review stage for production. we use the questions found on the second page of the attached sheet.

we do PFMEAs but only when the required by the customer.

Also, when we are asked for new products we hold a "new part production meeting" which usually includes supervisors/quality/manufacturing management. we use the list on page 1 of the attached document to review the processes the part will go through and what can potentially happen. (we do not keep records of this meeting)

and of course we conduct FAIs but that is a given for new products.

will this suffice AS9100D requirements of risk management
 

Attachments

Elsmar Forum Sponsor

howste

Thaumaturge
Super Moderator
#2
It looks like if it's implemented it could cover the operational risk requirements in 8.1.1. I don't think it meets the broader requirements (including opportunities) of 6.1.
 

Big Jim

Super Moderator
#3
If you have not done so yet, read the appendix about risk based thinking.

You will be expected to explain how you are aware of risks throughout the quality management system.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
I am wondering if this will fulfill the AS9100D requirement of risk management.

...SNIP....

will this suffice AS9100D requirements of risk management
That's impossible to answer. With so much variation between auditors, the range of answers could go from "heck, what nonsense is this?".....all the way to "why the overkill?"

The IAQG presentation has the following two slides on Risk Management.


As mentioned, there is an expectation for a formal risk management in place. Put one in place that you believe makes sense and present it to the auditor. If s/he says it is not good enough, then the question you must ask is: what is the requirement not being complied with?

Good luck.
 

Big Jim

Super Moderator
#5
That's impossible to answer. With so much variation between auditors, the range of answers could go from "heck, what nonsense is this?".....all the way to "why the overkill?"

The IAQG presentation has the following two slides on Risk Management.


As mentioned, there is an expectation for a formal risk management in place. Put one in place that you believe makes sense and present it to the auditor. If s/he says it is not good enough, then the question you must ask is: what is the requirement not being complied with?

Good luck.
I'm not sure if the word "formal" is quite the right or best term here. Established might be a better fit. A documented procedure is not required and record keeping specifically for 6.1 is not required although risk will likely show up in other required records.

I completely agree here that you need to have something that works and fits YOUR organization, and it can be as "formal" as you want it to be.
 
J

jmariscal90

#8
thanks for the inputs, I feel like I need to be further educated on the matter. In the mean time, I will review the risk management appendix mentioned.
 
Thread starter Similar threads Forum Replies Date
S How to fulfill PFMEA "requirement" column? FMEA and Control Plans 2
Q Is a DHR enough to fulfill 13485:2016's Medical Device File requirement? ISO 13485:2016 - Medical Device Quality Management Systems 3
MDD_QNA IEC 60601-1 Ed2 vs Ed3 - Does a product that conforms to Ed3 also fulfill Ed2? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T How to fulfill IEC 60601-1-2 EMC Testing Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
P What is to be documented to fulfill the requirements of ?820.65 Traceability? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Would Design & Process FMEA (PCBA) be sufficient to fulfill requirement of Cl 7.1? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Does that Q-Policy fulfill ISO 9001 requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L How do you fulfill TS 16949 Clause 5.5.3? IATF 16949 - Automotive Quality Systems Standard 4
H Does Powerway's APQP - PPAP fulfill TS16949 document and data control requirements? Customer and Company Specific Requirements 2
A AS9100D 8.1.4 Prevention of Counterfeit Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
B Purchasing AS9100D Standard in Japanese AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Stefan Mundt AS9100D Major nonconformity due to recurrence of a NC during a subsequent CB audit. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B AS9100D Sampling Plan AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What To Clauses Exclude - AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
F AS9100D Internal auditing requirements Internal Auditing 3
A AS9100D FAI requirements needed? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
F AS9100D Process Matrix for a small cnc machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
C AS9100D -8.5.1j - Accountability For All Products Tiny Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Free downloadable AS9100D audit checklist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
K AS9100D Clause 7.5.2.a) - What is considered to be "documented information"? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
Nicole Desouza AS9100D - Calibration of Dies & Tooling - Plastic Extrusion AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
S AS9100D PEAR - Examples for organization's method for determining process results? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
K AS9100D 8.4.1.1 external providers question - Walmart, Home Depot, our lawn care team. etc. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
W Core Process Metrics AS9100D for Product Planning? Quotes and sales? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
C Taking exception to customer requirements or specifications & AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
I AS9100D Non-conformance for 10.2.1 b 2 and 10.2.1. b 3 e and f - Corrective Action AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
M AS9100D Competence and Training Records - X-Ray AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P Design exclusion in AS9100D for commercial products AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
N Claiming exemptions (N/A) in AS9100D - what is the methodology and location? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M AS9100d (section 7.1.3) example of compliance in machine shop environment. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D AS9100D implementation question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
Y Time gap for First Surveillance Audit of AS9100D after initial certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
H AS9100D Cert question - Small machine shop - Where can I buy a certificate? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M AS9100d Controlling External Provided Processes (purchasing 8.4) - The customer want us to use supplier X AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
C AS9100D 7.1.5.2 / Calibration of Employee Owned Measuring Equipment AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A CAR from 3rd party AS9100D auditor - Root cause dilemma AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 45
Q AS9100D Corrective Action Procedure needed Document Control Systems, Procedures, Forms and Templates 1
A What does a good business practice Process Audit look like for AS9100D? Process Audits and Layered Process Audits 9
J AS9100D - Good ways to document an internal audit plan / schedule Internal Auditing 25
C AS9100D, Clause 8.1 - Operational Planning and Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
C AS9100D Contract Review Contract Review Process 8
J What to expect during a Change of Location Audit under AS9100D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L AS9100D Requirements vis-a-vis Section 8.5.1.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J AS9100D Cl. 8.4.3d - The organization shall communicate to external providers... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J AS9100D Sections related to 1st Piece and In-Process Inspection Manufacturing and Related Processes 15

Similar threads

Top Bottom