Q
QA-RA Jones
All:
I am hoping someone can help identify to me if we are on the right track with our system or not in how we differentiate complaints vs nonconformances...
Customer Complaints (External nonconformance): When a customer identifies an issue with our parts we issue a customer complaint in our system (often times there will be an NCMR form the customer will send us identifying the issues they found - this record will be maintained in the complaint processes form). Through this complaint system we complete three steps: Complaint Initiation, Complaint Investigation/Root Cause, and Complaint Resolution (Corrective and/or Preventive Actions). We always address corrective and possible preventive actions through this system as applicable. If we receive more than one complaint and it continues to be an issue we will launch our CAPA form for a systematic addressing of the issues at hand and more in depth look at to what systematically needs to be addressed, this would further include verification of systematic correction after a period of 3-6 months depending on the issue.
Nonconformances (internal nonconformance): When we identify an issue with a part internally during final inspections we will issue a nonconformance internally, if this is in relation to work a vendor completed we will issue them our form to complete the investigation/root cause and possible corrective/preventive action. Through this form we complete the following steps: Nonconformance initiation, Nonconformance investigation/root cause, and Nonconformance Resolution (Corrective and/or Preventive actions determined by MRB). If we receive more than one nonconformance on the same issue we will launch our CAPA (or SCAR) form for a systematic addressing of the issues at hand and more in depth look at what systematically needs to be addressed.
Outside of these two processes CAPA's can be initiated based off an observation or audit finding, etc (we utilize a risk based approach to determining if CAPA is necessary).
In order to reduce the amount of paperwork we do not issue a nonconformance for any of our complaints, as this is extremely redundant and provides the same output in either form. We are always doing an investigation and resolution determination for both processes and they both feed into the CAPA system.
Does this seem like an adequate way to approach these systems?
Also, if we receive a complaint on a product in the field and it is a vendor supplied part my thought is that we could just issue them our complaint form with the initiation completed so that they can address the investigation/root cause. No additional nonconformance forms would need to be created, again due to redundancy. Does this seem like a correct approach?
Thanks for any input you can all offer. It is greatly appreciated!
I am hoping someone can help identify to me if we are on the right track with our system or not in how we differentiate complaints vs nonconformances...
Customer Complaints (External nonconformance): When a customer identifies an issue with our parts we issue a customer complaint in our system (often times there will be an NCMR form the customer will send us identifying the issues they found - this record will be maintained in the complaint processes form). Through this complaint system we complete three steps: Complaint Initiation, Complaint Investigation/Root Cause, and Complaint Resolution (Corrective and/or Preventive Actions). We always address corrective and possible preventive actions through this system as applicable. If we receive more than one complaint and it continues to be an issue we will launch our CAPA form for a systematic addressing of the issues at hand and more in depth look at to what systematically needs to be addressed, this would further include verification of systematic correction after a period of 3-6 months depending on the issue.
Nonconformances (internal nonconformance): When we identify an issue with a part internally during final inspections we will issue a nonconformance internally, if this is in relation to work a vendor completed we will issue them our form to complete the investigation/root cause and possible corrective/preventive action. Through this form we complete the following steps: Nonconformance initiation, Nonconformance investigation/root cause, and Nonconformance Resolution (Corrective and/or Preventive actions determined by MRB). If we receive more than one nonconformance on the same issue we will launch our CAPA (or SCAR) form for a systematic addressing of the issues at hand and more in depth look at what systematically needs to be addressed.
Outside of these two processes CAPA's can be initiated based off an observation or audit finding, etc (we utilize a risk based approach to determining if CAPA is necessary).
In order to reduce the amount of paperwork we do not issue a nonconformance for any of our complaints, as this is extremely redundant and provides the same output in either form. We are always doing an investigation and resolution determination for both processes and they both feed into the CAPA system.
Does this seem like an adequate way to approach these systems?
Also, if we receive a complaint on a product in the field and it is a vendor supplied part my thought is that we could just issue them our complaint form with the initiation completed so that they can address the investigation/root cause. No additional nonconformance forms would need to be created, again due to redundancy. Does this seem like a correct approach?
Thanks for any input you can all offer. It is greatly appreciated!