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Hi fellow cove dwellers,
I am designing a light weight and efficient QMS for a *very* small SW company. Most CAPA threads seem to very HW oriented.
If you go by the book you would have different procedures, and possibly tools, for problem reports, customer complaints, CAPA, incident reporting etc.
This is simply out of the question for my client, they would never make it work in practice.
What I am thinking of is to use one tool for "issues" from many sources, from simple internal bugs to adverse event reporting.
The tool will have provisions, check boxes and information fields, that will support the different processes.
As an example, a prototype version has a checkbox: "Risk analysis needs to be updated" [Yes, No, Not checked (Default)] This way I want to force them to make active decisions.
The only thing I have to do is to write a SOP to guide them through the "issue" handling and prescribe what steps have to be taken for different classes of issues. The current prototype uses ["Simple bug", "Larger change that needs document changes", "Documentation change", "Adverse event"].
The C and P in CAPA would simply be decisions in the "issue" handling process.
Any thoughts on my approach?
I am designing a light weight and efficient QMS for a *very* small SW company. Most CAPA threads seem to very HW oriented.
If you go by the book you would have different procedures, and possibly tools, for problem reports, customer complaints, CAPA, incident reporting etc.
This is simply out of the question for my client, they would never make it work in practice.
What I am thinking of is to use one tool for "issues" from many sources, from simple internal bugs to adverse event reporting.
The tool will have provisions, check boxes and information fields, that will support the different processes.
As an example, a prototype version has a checkbox: "Risk analysis needs to be updated" [Yes, No, Not checked (Default)] This way I want to force them to make active decisions.
The only thing I have to do is to write a SOP to guide them through the "issue" handling and prescribe what steps have to be taken for different classes of issues. The current prototype uses ["Simple bug", "Larger change that needs document changes", "Documentation change", "Adverse event"].
The C and P in CAPA would simply be decisions in the "issue" handling process.
Any thoughts on my approach?