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Good Day Everyone!
First post here on the forum, I work as the Quality Manager of small ISO 13485:2016 certified facility that is a contract manufacturer for surgical instruments (non-sterile). We recently underwent our recertification audit and a Major NC was found and described as " Equipment Validation process is not effective because the organization does not document procedures for validation of process including:
a) defined criteria for review and approval of processes;
b) equipment qualification and qualification of personnel;
c) use of specific methods, procedures and acceptance criteria;
d) as appropriate, statistical techniques with rationale for sample sizes;
e) requirements for records;
f) revalidation, including criteria for revalidation;
g) approval of changes to the processes"
My reason for joining posting here, is to request help for how to proceed with my CAP. My current SOP specifies what processes we deem special internally, what specifics must be included in the report for special process validations, the other aspects of the validation program are captured in our MVP which is a controlled document. The MVP specifies re-validation frequencies, protocols, record keeping requirements, approval/change requirements for the document to be revised, and RPN scores for processes.
Could any one please provide some guidance on how to go about generating an acceptable Corrective action plan? This is my first audit to actually have a major NC. I know I will need to revise my procedure to encompass the above listed elements, but I am on a very short time table for the corrective action plan submission and want to be thorough to ensure its acceptance.
edit: I am in process on performing a 5 why root cause analysis now
Thank you all in advance for your help!
First post here on the forum, I work as the Quality Manager of small ISO 13485:2016 certified facility that is a contract manufacturer for surgical instruments (non-sterile). We recently underwent our recertification audit and a Major NC was found and described as " Equipment Validation process is not effective because the organization does not document procedures for validation of process including:
a) defined criteria for review and approval of processes;
b) equipment qualification and qualification of personnel;
c) use of specific methods, procedures and acceptance criteria;
d) as appropriate, statistical techniques with rationale for sample sizes;
e) requirements for records;
f) revalidation, including criteria for revalidation;
g) approval of changes to the processes"
My reason for joining posting here, is to request help for how to proceed with my CAP. My current SOP specifies what processes we deem special internally, what specifics must be included in the report for special process validations, the other aspects of the validation program are captured in our MVP which is a controlled document. The MVP specifies re-validation frequencies, protocols, record keeping requirements, approval/change requirements for the document to be revised, and RPN scores for processes.
Could any one please provide some guidance on how to go about generating an acceptable Corrective action plan? This is my first audit to actually have a major NC. I know I will need to revise my procedure to encompass the above listed elements, but I am on a very short time table for the corrective action plan submission and want to be thorough to ensure its acceptance.
edit: I am in process on performing a 5 why root cause analysis now
Thank you all in advance for your help!