Charts and Diagrams as Controlled Documents - Do all kinds have to be controlled?

Q

qavalentine

#1
Our procedure states that "Charts and Diagrams that provide operator instructions or facility developed specifications shall be considered controlled documents and will be maintained as part of the Charts and Diagrams work instructions" It goes on to say..." Any other chart and diagram with information that is not directly controlled by this facility (temperature conversion charts, state codes, etc.) may be used at individual workstations in an uncontrolled status."

A third party auditor made an observation that all charts and diagrams need to be "controlled" documents. Would anyone suggest controlling these charts or deleting this sentence all together.....Any suggestions would be appreciated.
 
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K

Kevin H

#2
Stating that all charts and diagrams need to be controlled, is a bit overreaching and an easy way for an auditor to find a "gotcha" every time they audit you. You need to find some way to determine what charts and diagrams are used, and how you want to control them. For example, in a prior position we used Rockwell Hardness equivalency charts provided by Wilson Instruments when we had to report a Rockwell 30N hardness, but due to material thickness of the sample being tested we had tested a Rockwell 15N hardness. We used the chart to calculate the equivalent hardness number on the desired Rockwell scale. We ended up controling those equivalency charts.

Basically, if you use a chart or diagram and it's important to use a particular one or a particular revision of one it should be controlled.
 
#3
Hello qavalentine, and welcome to the Cove
qavalentine said:
A third party auditor made an observation that all charts and diagrams need to be "controlled" documents.
My first questions will be: Why, and acc. to what clause? Can you provide us with the exact wording of the observation?

/Claes
 
B

bakdbeenz

#4
qavalentine,

Had the same observation / finding on my ISO9001 pre-registration audit a few years ago.

Simple solution: Each form that is used to construct a chart is controlled (eg XR Charts). The completed chart becomes a quality record and is dealt with in the usual manner. In controlling the form, when charting requirements change, that change is defacto communicated. We keep all our controlled forms in an electronic document vault - accessible/printable facility wide. The problem becomes, some operators like to printout a 1/2 year's worth of forms, rather than printing what they need this week. Thus still frequently find obsolete forms in use.
 
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