On-the-floor work instructions - Appropriate control of

J

jwesser

#1
#1
We have been experiencing some 'challenges' with our on-the-floor work instructions and the appropriate control of these documents. A quick background...these instructions are for the operator to use when assembling a product. We do not expect a well-trained and experienced operator to thumb through these instructions everytime the product is built. These work instructions and revision level are referenced on the work order, so that an operator knows what work instructions are available to him/her. These documents are mostly for new employees, and are referenced in the Training Guidelines. We are currently labeling these on-the-floor work instructions as uncontrolled. The operator is required to reference the Work Order, where the document number and revision level are inputed, to determine if he/she has the appropriate documentation. I was just curious to see what other people have done to comply with ISO requirements, how does your perspective differ from ours? Is this the wrong approach? Are there more efficient ways of communicating this information?

Thank You,
Justin
 
QMS for Medical Device Companies
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R

richard b. thomas

#2
#2
It is my understanding that you identify in the documents and/or work orders the current revision level for each work instruction. What would the operator do if he/she reviews the revision level stated in the work order and it isn't the same as the revision level of the work instruction currently being used or issued? Taking this scenario I would expect that your quality system should control these documents to ensure that the most recent or current issue is in place and those that become obsolete are removed promptly. I have found from my experience that it is best to control documents that have a direct affect on quality.
 
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