Pat McGhie said:
Katy, I am just about where you were.... Anything you can share on risk assessment???
We make plastic molded parts that are components of someone elses device. No design of the parts etc.. We have a contract and build to PO/Print
Pat McGhie
Do what is best for your operation. The biggest key is to prove that you are addressing risks at THROUGHOUT your process. If you do not decide to create
FMEA's or other typical methods of documentation, think of the logical places in your process that may pose risks: like taking orders for new products, making changes to drawings and processes, reworking parts, salvaging nonconforming materials, and other activities not listed here. If you can list the "activities" that may pose a risk to your product/process integrity, you can decide how you want to document/prove the risks have been identified, evaluated, and addressed. This may be a fairly simple record like adding a block to the appropriate forms for listing product risks, identifying actions to address the risks, and approval authority. Also, device masters tie into the equation. At first I tried to get everything together in one location, including records of risk assessments, until I realized it was easier in the procedure to simply list the items that make up a device master and their storage locations.
I had a document review by my Registrar prior to the audit. You may want to do it so that you know the documentation has been written in a manner that supports the requirements of your standard before you have to "prove" that you are doing it during the audit.
Good Luck!
By the way, WELCOME TO THE COVE!
ZeissUser huh??? I do miss my Zeiss, we run Brown and Sharpe now with PCDMIS. It is fun to get out from under the paperwork sometimes and do some hands on programming. Best of luck with your registration audit!
