Use of white-out or obliterating a portion of a controlled drawing or document

C

cgaro

#1
Hi - can anyone tell me where in ISO 9001:2008, 13485 or AS9100 is the use of white-out or obliterating a portion of a controlled drawing or document prohibited?

Thanks!!
Cgaro
 
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Wes Bucey

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#3
Hi - can anyone tell me where in ISO 9001:2008, 13485 or AS9100 is the use of white-out or obliterating a portion of a controlled drawing or document prohibited?

Thanks!!
Cgaro
In the six intervening years since I responded to one of the threads Marc has cited (in post #3), I haven't seen any reason in subsequent revisions of any Standards to amend my response. The point is simply that changes to a document MUST follow a protocol. I discussed this in the thread Ethics - Moral law vs. Criminal law starting in post #1 where I wrote
  1. Confirm your suspicion that you witnessed wrongdoing on purpose versus from ignorance. A guy who realizes he transposed his digits the first time he wrote an inspection dimension and erases the error is not a criminal - just a fool. A manager who creates a forged SPC chart to meet a 1.33 Cpk requirement is both a fool and a criminal.
  2. If the wrongdoing is from ignorance, your primary responsibility is to inform someone in authority within the organization so they can investigate and take some sort of corrective or preventive action.
  3. If the wrongdoing is from criminal intent, you ought to determine if it is limited to one individual or is systemic.
  4. If individual, see item (2), unless it is the very top officer; if systemic, or the top officer, see a qualified employment lawyer first, before gathering documents or secret recordings. The primary purpose of the lawyer is to protect you and your family, then to expose the criminal activity to proper authorities, perhaps even to cooperate or collaborate with authorities. Under no circumstances should you attempt to do any cooperation or collaboration with authorities without advice and agreement from your attorney every step of the way.
inciting a spirited followup discussion. In post six, I wrote
Carl is correct. Humans make errors. Compounding the error by trying to cover it up by erasing, rather than acknowledging the error and making a notation WHY it was corrected has multiple ramifications:
  • can the work instruction or environment be modified to reduce or eliminate such errors? (We won't have an opportunity to improve if we don't know errors occurred.)
  • is there a governmental regulation which strictly forbids deleting or covering up errors? (is the employee aware of the regulation? was he properly instructed? does more emphasis need to be made in the training program?)
  • was there an atmosphere of FEAR which made the employee afraid to acknowledge an error for fear of retaliation or other penalty?
  • does the employee have real dyslexia? (Can it result in a mistake that he doesn't catch? Who will it affect? Is there life, health, safety involved?)
  • etc. etc. etc.
Does this put the "foolish" comment by me in perspective?
Ultimately, the point is NOT whether there was an erasure or whiteout, but that there was no traceability of who or why the correction was made.

If there is a notation as to WHO applied the whiteout, WHEN it was applied, and WHY, then the problem of traceability is ameliorated. In my experience, the issue is a management one - does the management have a specified process for changing documents? Do all personnel know and apply this process? Does management follow up to assure the process is adhered to and followed on every occasion? What is the process when a document is discovered changed without the requisite traceability notations? (In my opinion, any change without traceability of WHO, WHY, WHEN makes the document invalid for record purposes.)
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
The relevant clauses refer to records being legible.

The extent of the concern depends on what the records are for. Some industries are very particular while others are not. Many of the considerations are based on the role the records might play in legal proceedings. The interest there is generally ensuring the previous entry can be accurately read.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
<snip> Many of the considerations are based on the role the records might play in legal proceedings. The interest there is generally ensuring the previous entry can be accurately read.
Jennifer is right on. I was trying to think of an auditor in ISO 9001 who wanted to write up white-out stuff. My being from DoD work, it was always "strike through" and initial and date any change. Much stricter than any specific ISO 9001 requirement. It ended up as a observation. Regulated industries have much stricter requirements.

I'm old school - Any changes have to be initialed or signed and dated, and
any/all previous entry/entries can be accurately read.

Good example is Wikipedia reference-linkValuJet_Flight_592 - The oxygen generator inspections were "revised". AKA Fraud.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
I always ask my clients, sooner or later (that is, have I found white-out or writeovers/scribbles yet or not) what their policy is and what it's based on. The question has aroused a lot of interesting discussions but I know there are certain groups for whom legibility is important. One among them is Underwriters Laboratories, and of course the Process Safety Management record is also important. So I often end up writing an OFI on those premises, unless of course they have clear requirements - of course that ends up with an Action Request.
 
C

cgaro

#8
First, thank you everyone for input, it has been very helpful :applause:

The incident that occurred was this; a document control tech used white-out to obliterate a previous note (requirement) on a master test report used to verify test measurements against and then wrote in the new requirement rather than go through the process of retesting a known acceptable cable and updating the master test report the correct way.

And yes to all, our Doc Control Procedure does state that the use of white-out or pencil is prohibited for making changes.

All of the replies and comments are very helpful to me, again, thank you!!
 
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