AS9100D Non-conformance for 10.2.1 b 2 and 10.2.1. b 3 e and f - Corrective Action

ImLost

Starting to get Involved
#1
We hired an outside auditor to complete our internal audits; they gave us a non-conformance for 10.2.1 b 2 and 10.2.1. b 3 e and f.

We've added a drop down to in our CAR program to select possible Human Factors related, but I dont know how to implement the other 2.

Any suggestions?
 
Elsmar Forum Sponsor

ImLost

Starting to get Involved
#3
Its very vague;
Finding: The process for corrective action is not fully effective
Objective Evidence: The corrective action system does not address Human Factors, updating the risk and opportunities determined during planning, and make changes to the QMS.
Claue: 10.2.1
 

Pjservan

Involved In Discussions
#4
If you have a procedure, then state how these items are covered or addressed. If no procedure I have seen companies address this by including this as part of their form/system. The Human Factors as you described and the other two as a part of the closure of CAR where it is a question whether R/O or QMS changes/updates are needed to further address the CAR.
 

ImLost

Starting to get Involved
#5
The Human Factors as you described and the other two as a part of the closure of CAR where it is a question whether R/O or QMS changes/updates are needed to further address the CAR.
Thank you - We do have a procedure; I didn't want to unnecessarily bog down an already busy form with additional boxes, drop downs, etc.
We added the human factors box, but now I am wondering if we really need it (as we would have to select a HF with each non-conformance, right?)
 

Golfman25

Trusted Information Resource
#6
I think adding notes to your CA form is probably the most helpful. How many people actually refer to the procedure after a while? That can lead to a miss or forgetfulness. You always have the form in front of you during the CA process. Just check the box that you considered the requirement and move on.
 

ImLost

Starting to get Involved
#7
VERY good point @Golfman25!

So now - to play into that - it has to be considered, but does there need to always been an answer - would it be too simple to put buttons for YES and NO (as in were R/O considered)?
 

Pjservan

Involved In Discussions
#8
The requirement on human factors in corrective actions is: "determining the causes of the nonconformity, including, as applicable, those related to human factors;..." so agree, a Y/N question could work.
 

John Predmore

Quite Involved in Discussions
#9
I dont know how to implement the other 2
There are four clauses referenced. You said you already added Human factors to your CAR. AS9100 says
10.2.1 b. evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by: [... ]
- 2. determining the causes of the nonconformity, including, as applicable, those related to human factors;
- 3. determining if similar nonconformities exist, or could potentially occur;
- e. update risks and opportunities determined during planning, if necessary;
- f. make changes to the quality management system, if necessary;

I suggest you add comment fields to your CAR form whether
(b3) this problem/failure reads across to other lots, product lines or departments (use words that make sense in your factory).
(e) your risk document was/was-not updated based on this incident (if not, why?)
(f) QMS changes were made (if so, what? if not necessary, why?)
 

Big Jim

Trusted Information Resource
#10
If you have a procedure, then state how these items are covered or addressed. If no procedure I have seen companies address this by including this as part of their form/system. The Human Factors as you described and the other two as a part of the closure of CAR where it is a question whether R/O or QMS changes/updates are needed to further address the CAR.
Keep in mind that AS9100D requires a written procedure for corrective actions.

10.2.1 ends with: The organization shall maintain documented information that defines the nonconformity and corrective action management processes.
 
Thread starter Similar threads Forum Replies Date
B Purchasing AS9100D Standard in Japanese AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
Stefan Mundt AS9100D Major nonconformity due to recurrence of a NC during a subsequent CB audit. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
B AS9100D Sampling Plan AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
A What To Clauses Exclude - AS9100D AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
F AS9100D Internal auditing requirements Internal Auditing 3
A AS9100D FAI requirements needed? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
F AS9100D Process Matrix for a small cnc machine shop AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
C AS9100D -8.5.1j - Accountability For All Products Tiny Parts AS9100, IAQG 9100, Nadcap and related Aerospace 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 9100, Nadcap and related Aerospace Standards and Requirements 5
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
Nicole Desouza AS9100D - Calibration of Dies & Tooling - Plastic Extrusion AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
Q What is the difference between AS9100D 9.3.2.f and 9.3.3.a AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
S AS9100D PEAR - Examples for organization's method for determining process results? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
K AS9100D 8.4.1.1 external providers question - Walmart, Home Depot, our lawn care team. etc. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 20
W Core Process Metrics AS9100D for Product Planning? Quotes and sales? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
C Taking exception to customer requirements or specifications & AS9100D AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
M AS9100D Competence and Training Records - X-Ray AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
P Design exclusion in AS9100D for commercial products AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
N Claiming exemptions (N/A) in AS9100D - what is the methodology and location? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
M AS9100d (section 7.1.3) example of compliance in machine shop environment. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
D AS9100D implementation question AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
Y Time gap for First Surveillance Audit of AS9100D after initial certification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 13
H AS9100D Cert question - Small machine shop - Where can I buy a certificate? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
M AS9100d Controlling External Provided Processes (purchasing 8.4) - The customer want us to use supplier X AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
C AS9100D 7.1.5.2 / Calibration of Employee Owned Measuring Equipment AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
A CAR from 3rd party AS9100D auditor - Root cause dilemma AS9100, IAQG 9100, Nadcap and related Aerospace 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 9100, Nadcap and related Aerospace 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 9100, Nadcap and related Aerospace Standards and Requirements 0
L AS9100D Requirements vis-a-vis Section 8.5.1.3 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
J AS9100D Cl. 8.4.3d - The organization shall communicate to external providers... AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
J AS9100D Sections related to 1st Piece and In-Process Inspection Manufacturing and Related Processes 15
K AS9100D - Is the PEAR required? Internal Auditing 1
M CB and Internal auditors most common nonconformities against AS9100D AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 16
D AS9100D vs AS9120B differences AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
J AS9100D Clause Brain Fade - Tool was past due for Calibration AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
M AS9100D Process Map Requirements - PEAR Forms AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 18
C AS9100D Flag AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
K Maintenance requirements for Production Equipment in AS9100D General Auditing Discussions 8
I Trying to explain some of the Management Review Inputs (AS9100D) Management Review Meetings and related Processes 10
K AS9100D production process scheduling requirements Internal Auditing 14
D AS9100D 7.3 Awareness of customers quality policies AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 18
A AS9100D, Clause 8.4.1.1 - External Provider Scope of Approval AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 16
D Number of Audit Days - AS9100D Transition for a Small Shop AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
Similar threads


















































Top Bottom