Handwriting/changes on controlled document

[ivan99]

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...

 

[noboxwine]

Is it time to go home yet?

Hey Ivan and Welcome to the Cove. I don't know how valuable my input is, but here goes.

Develop 4.2.3 and 4.2.4 to best suit your business needs and live to it. An auditor cannot ding you, unless your failing to live within your own documented guidelines. They may not like your approach, but they are there to audit you to the standard, not give their opinions on your business practices. You'll do just great. Good luck and let us know! Next.................

:thedeal:

 

[energy]

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!

 

[ivan99]

Reply to Energy

So Energy...what you saying is I CAN but only if I use your 5.2.2 example? Which means I won't be dinged if it is indicated in my document control procedure, right?

 

[tomvehoski]

I agree with Energy, but I don't go to quite the level of control as no pencil or whiteout. I usually just state in a procedure that "Insert title(s) here" is allowed to make temporary changes to process control documents by changing, initialing and dating the change. As long as the system allows handwritten changes (and they are kept to a minimum) you should not get "dinged". Some systems, such as aerospace, may need the tighter controls energy mentions.

Only time I have had a client hit in an area like this was because the change was on a post-it note with was not securely attached to the blueprint. As I recall it became a verbal "watch that" and was not even written as a nonconformance.

I have heard of auditors that will not allow pencil on ANY document and will even go to the point of erasing a clients document to "prove it is not protected". These auditors will never audit one of my clients.

Tom

 

[energy]

Re: Reply to Energy

ivan99 said:

So Energy...what you saying is I CAN but only if I use your 5.2.2 example? Which means I won't be dinged if it is indicated in my document control procedure, right?

Yup, for sure. YOU write the procedure. Nobody can tell you otherwise!

Tom,

Call it time aged semi--anal fear of allowing crayons or jumbo markers to make the changes. Whatever is in their pockets at the time, they think will do. Ain't got time to do it right. Got parts to make. Schedules to meet! Yea, but, whoa, you obscured all the relevant information, you MENSA membership lacking Lunkhead!

 

[Ken K]

I have heard of auditors that will not allow pencil on ANY document and will even go to the point of erasing a clients document to "prove it is not protected". These auditors will never audit one of my clients.

Personally, I think the auditor has a point. Like energy said, I'd hate to see it return marked up with crayon or magic marker.
Pencils have their place, but on a controlled document?

 

[gpainter]

We allow for handwritten changes as long as they are done in our specified way and by certain groups of people. Once they are turned in the changes are formally typed in. We have had no problem with this method.

 

[HFowler]

ivan99 said:

I intend to use my work order packet ...as a CONTROLLED DOCUMENTED procedure and a RECORD. Requirements on this packet of materials get amended by the order taker...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? ...

Ivan99,

I've never heard of using a work order packet as a procedure, not to say that it can't be done. IMO, the part that an auditor will have difficulty with are the "uncontrolled" revisions made by the order taker. I would at least make sure that those get dated and initialed.

Good Luck!
Hank Fowler

 

[ivan99]

reply to Hank F

Hank:
By placing instructions in the form of bar code on the WorkOrder to indicate the sub-process used. I am calling those a "procedure" since it tells the operator what to do? I do not really differentiate between a procedure and a work instruction, I call both procedures...makes life easier 4me...