ivan99 said:
I intend to use my work order packet (contains drawings, process instructions etc...) which travels with the product throughout all the product realization processes as a CONTROLLED DOCUMENTED procedure and a RECORD. It gets signatures along the way and data are entered manually in it by operators. Sometimes, more often than not, certain requirements on this packaet of materials get amended by the order taker (customer service usually) but that person does not sign or date the change...am I going to be "dinged" on this by the auditors or can I address it in my document control procedure? and get away with it as is? thanQ all for you valuable input...
IMHO, yes you will get "dinged" because of what appears to be unauthorized changes to controlled documents. Here is an excerpt from a procedure used in my previous life:
5.2 Revisions to Master Process and Process Traveler
5.2.1 Any revisions to a Master Process shall be recorded on an XXX-XXX-XX Engineering Change Request form. The form shall be signed off by the QA Manager or QA Engineer and a member of Engineering, as well as Production Control. The revision of the Engineering Change shall be denoted on the Process Traveler and the completed form shall be retained in Engineering indefinitely.
5.2.2 All additions and/or corrections to the Process Traveler shall be made using ink. Pencils or white-out shall be prohibited. If entry is to make a correction, a single line will be drawn through the incorrect information and the correction legibly added. Authorized personnel (Dept. Supervisors) making such entries shall initial and date the Process Traveler adjacent to same.
Just an idea!