Question
During our certification for AS9100C the auditor found some documents with correction liquid that we have used for years. We have prohibited the use of any type of correction on all processes company wide.
It is common that during the prototype stage we performed dozens of changes due to the differences between the calculating/design program (electrical) and what happens in real life. During those adjustments we change manually circuits, values, etc. from the original version, with white-out tapes (before was liquid paper) once the prototype works those changes are incorporated as “Initial release” in the package that goes out for manufacturing. Do you guys see any problem using white out tape / correction tape on the controlled copies during prototype stage? My point is that the original values are recorded on the originals that will be obsoleted and the new ones on the initial release, keeping the controlled copies marked as records of the prototype.
Response
Thanks for contacting ASQ’s Ask the Experts program.
With regard to your inquiry, changing the documented results of inspection or test activities should be avoided or at least strictly controlled. This is of special importance if these records are intended to provide evidence of product or process conformance.
However, prototype test results which may be subject to frequent changes during preliminary inspection or test activities, doesn’t require the same level of control. These results are usually intended for informational purposes only and not for final acceptance of a process or product.
Bill Aston
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
Kingwood, TX
http://www.astontechconsult.com
Drawings and other supporting documents used during prototype testing or product development will normally go through numerous changes before they are finally approved and issued to produce a finished product. Marking, initialing and dating every change made on preliminary design documents during the prototype phase is a good idea in theory, but may not always be practical. This is especially true when complex design is involved and prototype work may include frequent changes and last for weeks, months or longer.
I certainly don’t recommend or support the use of whiteout or correction tape on controlled documents, particularly when the changes are isolated or infrequent. In this situation, changes could easily be marked, initialed and dated. However, as already mentioned, documents used for informational purposes during the product design stage are not normally expected to meet the same requirements as documents that have been approved and issued to produce a finished product. If so, every change made during the product design stage could require an EDC (Engineering Design Change) package to be issued to document and approve the change. This would be cost prohibitive and counterproductive.
What’s the point? The use of whiteout or correction tape may not be a preferred method for handling document corrections, however, there is no industry standard that specifically prohibits its use. Every organization has a responsibility to establish their own levels of control (policies/procedures) to ensure the integrity and validity of their documents and records. The level of control required should be relative to the potential level of risk associated with the activity. The more risk involved, the more control may be needed.
I hope this helps.
Bill Aston
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
Kingwood, TX
http://www.astontechconsult.com
Not sure I agree with the expert’s response. The key is when do the drawings become controlled copies and/or how much control do you want during engineering development. But, even during that stage ,I would never use white out. Make pen and ink changes, initial and date so that you have a readable history. Let the engineers play with the design during development until they settle on a prototype. Then place the drawings and design package under CM control.