Not every INCIDENT report will lead to a corrective action

Elsmar Forum Sponsor

Ninja

Looking for Reality
Moderator
#2
1. Trusted supplier rated for "Dock to stock" with no internal testing sent a bad batch for the first time in 20yrs...3 out of spec parts out of 400pcs.

My response: record the incident and tell the supplier. No further action necessary.
Why do a bunch of process through a CA system for something that probably won't happen again anyway?
If it does happen again (we have the incident on record to see that it's a repeat), we can choose differently then.

2. Operator put a label on upside down and the customer threw a fit.
1 issue over 10,000 labels over 4 years.
...the only reason that would even go in the incident log is the customer complaint.
There would be a CA stemming from the complaint...the CA would be "wait and see if it happens again in the next 6 months".

3. Z-axis motor on CMM broke during part measurement.
Replace it/fix it...stuff happens.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
But are these the reported events you listed?
If you want precise answers, you have to properly formulate the question. You are using terms like incidents, reported events, etc...If you are specifically asking about REGULATED ADVERSE EVENTS, be clear about what you are asking, the context, etc...

Quality of responses depend on the clarity of the question.
 

Ninja

Looking for Reality
Moderator
#5
1. Trusted supplier rated for "Dock to stock" with no internal testing sent a bad batch for the first time in 20yrs
This was reported from my guys when the fab run went south and we lost a day of casting...so "Yes".

2. Operator put a label on upside down and the customer threw a fit.
I'm the one whos ear got chewed off by the particularly OCD customer...so "Yes".

3. Z-axis motor on CMM broke during part measurement.
I was admin for the CMM and software...so "Yes".

Any of these could have been put into the corrective action system, none of them were by my choice (well, technically #2 was since it was a customer complaint, but it was closed about 2min. after it was entered into the system).

You wanted examples of "incidents" that didn't require a Corrective Action...I gave you two that had No CA at all, and one that had a wave of the hand in the CA system. If not these, what are you looking for (ref. Sidney's post)?
 

monoj mon

Quite Involved in Discussions
#6
Can anyone give some examples of corrective actions that are not always required for incidents?
We once received notification from regulatory authority about one 'event' reported by the 'user facility'. Later it was analyzed to be 'use error' where the user had previous history of repeating the same error with other devices (as conveyed by the user facility to our distributor) which never happened before with our device when used by other users and was the only isolated incident reported so far for our device. It was concluded not to have any corrective action for this.
 

Roland chung

Trusted Information Resource
#7
1. Trusted supplier rated for "Dock to stock" with no internal testing sent a bad batch for the first time in 20yrs
This was reported from my guys when the fab run went south and we lost a day of casting...so "Yes".

2. Operator put a label on upside down and the customer threw a fit.
I'm the one whos ear got chewed off by the particularly OCD customer...so "Yes".

3. Z-axis motor on CMM broke during part measurement.
I was admin for the CMM and software...so "Yes".

Any of these could have been put into the corrective action system, none of them were by my choice (well, technically #2 was since it was a customer complaint, but it was closed about 2min. after it was entered into the system).

You wanted examples of "incidents" that didn't require a Corrective Action...I gave you two that had No CA at all, and one that had a wave of the hand in the CA system. If not these, what are you looking for (ref. Sidney's post)?
Sorry, I thought everyone would automatically jump to vigilance when it comes to incidents and reported events.
Monoj mon did reply exactly what I wanted. You are welcome to keep adding to it, if any.
 
Thread starter Similar threads Forum Replies Date
T AS9100D Clause 10.2.1g Supplier Corrective Action for each and every nonconformity? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
D Does every piece of equipment used in a laboratory need to have an IQ protocol written and executed? ISO 13485:2016 - Medical Device Quality Management Systems 5
V Every good documentation practice observation is an data integrity issue US Food and Drug Administration (FDA) 7
E Does every metallic part have to be protectively earthed (class I ME)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R In a software development company: Is every bug reported by the customer a complaint? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
U SI 13 - Not Every Process Requires an Efficiency Measure IATF 16949 - Automotive Quality Systems Standard 1
Howard Atkins MSAs are now required on every feature of the control plan - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 13
K Is evidence of second party audits required for every supplier? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Interpretation or Definition of ‘Once Every 5 Days’ ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Defect Rate for asking for an RMA - Company wants an RMA for every defect found Supplier Quality Assurance and other Supplier Issues 10
A Is normal for FORD EU ask for the PSW every year APQP and PPAP 5
A Identifying context for every process in an organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
J Is it sufficient to send in my instruments for calibration every second year? Manufacturing and Related Processes 2
U Must every procedure be proceeded by a policy? Document Control Systems, Procedures, Forms and Templates 2
A Personal names in docs - Goes against every documenation practice I know! Document Control Systems, Procedures, Forms and Templates 30
D Anyone Practicing Approval Signatures on Every Page of a Doc? ISO 13485:2016 - Medical Device Quality Management Systems 2
S Conduct Customer Satisfaction Survey for every submitted Bid? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I Run a batch every year to revalidate the validated condition? Qualification and Validation (including 21 CFR Part 11) 4
O Is a full Internal Audit cycle every year required? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
A Is it mandatory to revise MSDS every three years? ISO 14001:2015 Specific Discussions 3
L Does every document on a project require a document number? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P Audit Design Process every Surveillance Audit - AS9104 Requirement? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
Ajit Basrur 10 Things Extraordinary People Say Every Day Coffee Break and Water Cooler Discussions 5
K Autoclave Log - Do we have to monitor the usage for every load? General Measurement Device and Calibration Topics 3
Y Must every Process have a Quality Objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
A Addressing every clause in ISO 17025 ISO 17025 related Discussions 1
N New to ISO 9001 - NCR for every defect? Nonconformance and Corrective Action 5
A Do controlled documents require a signature on every page as per 21 CFR 820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D Are signatures required on every page of a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
K Customer issues invalid SCAR and Chargeback every March Customer Complaints 6
F Is every activity required to be mentioned in BSC strategy map ? Quality Tools, Improvement and Analysis 1
C Does every procedure need to be included within a policy? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Does Every Staff need to read the ISO9001 Quality Manual from Cover to Cover? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
A Shall we raise SCAR/CAR for every defect as per our current procedure? Nonconformance and Corrective Action 4
Q 510K Checklist that considers every Design Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
V Do I need dimensionals performed for PPAP for every revision change? APQP and PPAP 2
E Every US state has Medical Device Regulations beside FDA Regulations Other US Medical Device Regulations 11
T Living Documents which change every day - Control or Uncontrolled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
Q Drawing Review Records Required for every Drawing (Print)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Process Objectives and Metrics - Should every documented process have objective? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T Is a Nonconformance Report required for every Customer Complaint? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
C BMU=CMC for every Calibration? ILAC Policy Clarification Measurement Uncertainty (MU) 3
K Must every CCP (Critical Control Point) have a (documented) procedure? Food Safety - ISO 22000, HACCP (21 CFR 120) 4
Q Does 21 CFR 820 really revise every year? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4

Similar threads

Top Bottom