C
cgaro
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
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 wroteHi - 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
inciting a spirited followup discussion. In post six, I wrote
- 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.
- 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.
- If the wrongdoing is from criminal intent, you ought to determine if it is limited to one individual or is systemic.
- 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.
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:
Does this put the "foolish" comment by me in perspective?
- 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.
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.<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.