First off, I need to say a quick ‘welcome’ to the new members of this group. Many thanks for coming on board after seeing the blog. This is where we kick around some fresh ideas about 9001.
Now this time, instead of telling a story in the usual format, I have decided to throw a case study into the mix. Let’s see how well you respond to the challenge of actually putting your knowledge into practice. It’s just a bit of fun but, in all seriousness, I am sure you like me want to keep your skills honed and there is no better way in my opinion.
Bear in mind these two questions and leave your replies in the box at the bottom:
a. Would you raise a CAR based on what you know already and if so what would it be and which paragraph would you raise it against.
b. Are there any other areas where you are thinking there is a possible CAR but would seek out more evidence before making a decision?
CASE STUDY STARTS
The company is a single site and fabricates cabinets out of metal sheet by using a computerised laser cutting machine; a forming press; general machining and TIG and MIG welding.
You discuss the control of documents with the QA Representative and start by asking to see the Index and Change Control system. You are handed the Quality Manual and told that the index is at the back in an appendix. You verify a list of procedures only but note that there is no revision number included, only the title. When you query this you are told “Well if we added that then every time we amend a procedure then we would have to amend the manual which would be a real bind”.
When you ask if there is any other document containing this information then you are told “No, we’ve always done it that way”. You ask to see a copy of the relevant procedure for Document Control but are told they have never been told they need one which is when you spot it is not on the list.
You enquire as to how the procedures are authorised and reviewed before issue and how the company then communicates with staff that amendments have been made. You are shown that each procedure has the author’s name typed into the footer of each procedure with the date of issue and that staff aren’t told of amendments.
New or amended procedures are filed in the main binder with a copy in each of the 4 departmental binders (Sales and Purchasing office, Drawing office, Warehouse and shop floor) and the old version shredded.
CASE STUDY ENDS
I look forward to hearing your opinions and I will send an Amazon voucher as a thank you to whoever I feel puts together the best case. Make your Quality stand out!