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Hi all,
I'm new, so I should introduce myself really quick. I'm Lexie, and I'm coming from a few years of QA experience in medical device manufacturing and have now been recruited as Quality Director in the machine manufacturing industry. Part of my job at this new place is to obtain ISO certification, so of course the first thing I do is conduct my own mini-audit just to get a feel.
First issue: they have no work instructions for the major machines. At my previous place of employement, we had a work instruction for everything. When I brought up the idea of having WIs for the machines here, I got some eyebrow raises. They explained that 1) their customers are not asking for it, and 2) it's impossible because the machinists are hired on 10+ years of experience, and training is performed as an apprenticeship. According to the foreman, "I can tell whether they know the machines or not after watching them for 90 days." (Small family company, so I don't know if it makes a difference.)
Do you have any recommendations for handling this, and is a WI necessary for everything?
Thanks in advance!!
I'm new, so I should introduce myself really quick. I'm Lexie, and I'm coming from a few years of QA experience in medical device manufacturing and have now been recruited as Quality Director in the machine manufacturing industry. Part of my job at this new place is to obtain ISO certification, so of course the first thing I do is conduct my own mini-audit just to get a feel.
First issue: they have no work instructions for the major machines. At my previous place of employement, we had a work instruction for everything. When I brought up the idea of having WIs for the machines here, I got some eyebrow raises. They explained that 1) their customers are not asking for it, and 2) it's impossible because the machinists are hired on 10+ years of experience, and training is performed as an apprenticeship. According to the foreman, "I can tell whether they know the machines or not after watching them for 90 days." (Small family company, so I don't know if it makes a difference.)
Do you have any recommendations for handling this, and is a WI necessary for everything?
Thanks in advance!!

