How do I conduct my API Q1, ISO compliant internal audits?

roneljdsilva

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#1
Hello my people in Cove!:bigwave:

We recently faced a process audit from one of our major clients and among a few findings/observations (which I will get back here for help), he noted that the method of conducting our internal audits were inaccurate. Well basically, we scheduled our audits department wise and chose clauses from the QMS manual (API and ISO) relevant to that department to use as reference. Am I doing this wrong?
He mentioned that audits have to be conducted process based where at a given time a specific process is audited. How do I tackle this problem?

On another note regarding analysis of data, how do I analyse "characteristics and trends of processes and products including opportunities for preventive actions"?

It would be great if this was made clear to me cos I'm gonna have a hell of a job closing these findings in my limited time frame. :bonk:
 
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bluepagen

#2
Good Morning. You said you have done your audits by department and it was pointed out to you that you should do them by process. I would write down each department and then across from that, what process the department covers.
Sales --- Marketing, Quoting, Receipt of Order, Review Requirements, Order Entry. Each of these are a process that happens in a Sales department.
Quality---- Review of documentation- material certs, process documents, test documents), Calibration, Inspection, hardness checks, mag particle inspection, control of non conforming product, NCR's...... each of these things happen in a Quality department (depending on your size)
Purchasing --- Selection of Vendors, quotes for supplies or outside services, issuing purchase orders, contacting a vendor when something is non conforming.
But each of these different departments have things in common --documents - control, records - retention, personnel - training and competency, infrastructure - phones, fax, email, computers, office space. Work environment - heating, cooling, electrical, safety.
One process leads to another. Sales gets an order, engineering looks over it, purchasing agrees that the material can be purchased, production confirms they can get it into the schedule, quality confirms they have the tools to inspect. Maybe warehouse has some in stock (materials management) and can allocate it for the job, if it has to be ordered, receiving will confirm it is what was ordered and send it to quality for inspection.

This is how we audit. By process. This is how we do risk, by process. Look at who you have and determine what they do.

If you need additional help, send me a message and I will try to help you. Be patient, and you will receive other comments.
 
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