My father recently asked me to check on the system being used by his company. As expected, I have seen some loop holes which disappoints me as well as my father. I am looking to something that might be able to help even if I am not around. Perhaps something that can monitor or track changes made into the system? Or better, if there is something that can automatically tracks what went wrong. I am hoping to be able to find a solution for my dad.
Um, I reported this for a forum change for you. As a new poster, you really don’t want this in the BBQ Pit.
Yes, it’s much better suited for What The Hell Are You Talking About.
Neat.
You should probably make an appointment with someone in Systems Engineering or Quality Assurance.
Hell no. Those guys are definitely in on it.
Did they have a compliance analysis or compliance matrix? That would yield a gap analysis, right? Which, in turn, would give them an action plan for re-achieving compliance, and then they could maintain that compliance.
As mentioned earlier this shouldn’t be in the Pit. This seems better suited for IMHO.
No, this is definitely a job for Central Services.
Also, welcome to the Dope, Phyllida.
What you should be doing is consulting someone who is familiar with the ISO9001 standard.
There are a few of us on this board who work with the standard and would be happy to answer any specific questions.
It might not be this standard, it might also be ISO13485.
And yes we’d be happy to answer specific questions.
Actually the first thing you should do in this scenario is determine if that man is really your dad.
A good resource to check is the Elsmar Cove site: Elsmar Cove Quality and Business Standards Discussions.
Many sub-forums, including one specific to ISO 9000 / 9001 / 9004: ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
Also, the ISO13485-specific forum:
Take a look at their sub-forums. Some of us here on the Dope have experience and can help. Many more here have opinions and you’ve seen some already. The Elsmar Cove forum will be much more focused. I’ve been a member there since 2007.
Sounds like somebody forgot about the new cover sheets for their TPS reports.
Hmmm. Did she get the memo?
ISO13485, are you crazy?? She’s trying to track changes made into the system. You’re out of order! The whole freaking system is out of order!
What’s the acceptable tolerance?
I object! I object!
Wait a minute, I need My Cousin Vinnie!
None, dammit! I object! Didn’t you hear me?
Um, can you repeat the part of the stuff where you said all about the…things?
It’s an old story. The man had a system, the system done did him wrong, and a lady is there to pick up the pieces. What more do you need to know?