The DREADED...."White Out"!!! *insert scary music*

G

gfreely

#1
Hey all...

I ran into something the other day that I haven't seen in YEARS...I was randomly sampling our router packages and I found corrections with White Out in some of the process entries. I almost had kittens on the spot. :mad:

I brought it up to some management peoples and received various responses, from "That's not supposed to happen" to "So? It looks neater." It *almost* escalated beyond my control :argue: (I am still employed so it didn't go TOO far...:lol:)

I scoured 9001:2k and our QAM, searching for something to back me up so I can shout from the rooftops (or the top of a desk at least) that this CANNOT go on. I can just see the expression on our ISO auditor or a customer auditor's face when they see a huge splotch of correction fluid on one of our controlled documents!

Can anyone tell me where I might find this in writing? If it needs to be incorporated into our QS, then so be it...but I wanted to find backup to see if maybe the follks who wrote this system maybe just...forgot? :confused:

ANY help would be greatly appreciated!
 
Elsmar Forum Sponsor

Wes Bucey

Quite Involved in Discussions
#3
To my knowledge and experience, the primary proscription for white out or erasure is only in regulated industries (pharmaceuticals, for one.)

Individual organizations may have specific procedures or work instructions which describe how changes may be made, but none of the Standards like ISO 9001, or even ISO 13485 (to my own recollection) have such a clause against erasure or whiteout.

What they DO SAY is the organization must (shall) have a procedure for controlling a document against UNAUTHORIZED changes. The case you have described is not so much against the manner of erasure or whiteout, but the fact the identity of the person making a change was not disclosed, nor the reason (audit trail) for such change.

If the organization's procedures and work instructions are silent on WHO may make a change (need more than one approval?) and the manner of change (x-out, line out, erase, whiteout, reprint, etc.), then the procedure probably should be modified (approvals, etc.) and all pertinent personnel trained and evaluated on the revised procedure.

In point of fact, the auditor would only ask to see the procedure which governs document changes, not go ballistic.
 

GStough

Staff member
Super Moderator
#4
What I've learned in my 16+ years in an FDA-regulated industry (medical devices) is that when someone uses white-out on a record, an FDA investigator may take it to mean that someone was trying to cover up something (nonconforming measurements, etc.) or falsify a record.

This is a very good reason NOT to use white-out, IMO. :yes:
 

John Broomfield

Staff member
Super Moderator
#5
It is in ISO 9001, see the requirement in clause 4.2.4 for legible records (the original record cannot be read) :).

You may need to have the managers teach this discipline to everyone, below is a fair-use extract from clause 4.13.2.3 of ISO 17025:2005:

"When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside. All such alterations to records shall be signed or initialled by
the person making the correction. In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data." :read:

Hope this helps (I think the "when" instead of "if" is very helpful).
 

John Broomfield

Staff member
Super Moderator
#6
I am also worried about the extent of this problem. For someone to go buy some White Out (fairly rarely needed these days) may indicate a chronic nonconformity.
 

bobdoering

Stop X-bar/R Madness!!
Trusted Information Resource
#7
If you have white-out on a controlled document ( print, procedure, etc.), you have an uncontrolled change. It may not be spelled out in the standard as "do not use white out", but the uncontrolled change is worth a finding in an audit.

Now, as far as data on a controlled form, ISO9000:2000 may not be as straight forward. What everyone mentioned about the regulated industries is well known to those folks. But, outside of that it would be up to you to specify that in your procedures. But, also, be fair. If you have cramped forms with no place to strike out and rewrite data be ready to get a mess that would fail clause 4.2.4 for legible records.

Don't feel bad. In spite what you have in your procedures, I would have likely reacted the same way you did.:cool:
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#8
This sounds so familiar. In my career that has expanded 25 years, this was instilled into my head that the use of white-out is wrong.

Funny that you brought this question up, because it was identified in my AS9100 Stage 2 assessment. There is nothing specifically addressing the use of white out, but as someone said, the records must be legible. That is what the Assessor stood on. I didn't disagree.
 
C

Craig H.

#9
There might be another concern here, but I could not find a reference to it. Years ago when I was a lab tech with my very own bound lab notebook (that I wish they had let me keep when I left...) I was told that there are times when those documents can be used for filing a patent, defending a patent, or defending an infringement claim (lawsuit). Therefore whiteout was not even allowed in the labs.
 
Last edited by a moderator:
Z

zancky

#10
just a consideration.
I remember that a long time ago when designers were artists working on A0 film, it was too expensive to print again the drawing. The designer "white out" the dimension to be changed and overprint the new requirement reporting the change in the note of the drawing. That may be a reason for ISO 9k and TS not to mention "white out is not allowed". It make no sense now on the Pc era.
 
Thread starter Similar threads Forum Replies Date
C The Dreaded Uncertainty Measurements - Confidence in your results Measurement Uncertainty (MU) 1
Wes Bucey That dreaded Job Interview Salary Question Career and Occupation Discussions 46
P MSDS for MVQ FDA White, Vinyl Methyl Silicone Rubber EU Medical Device Regulations 4
K AS9100 - 7.3 - Are these black and white questions with specific correct answers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Informational US – MITA UPDATES SERVICING AND REMANUFACTURING WHITE PAPER Medical Device and FDA Regulations and Standards News 0
M Informational DITTA White Paper on Cybersecurity: Best Practices in the Medical Technology Manufacturing Environment Medical Device and FDA Regulations and Standards News 0
M Medical Device News NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application” Medical Device and FDA Regulations and Standards News 0
optomist1 Recommend Primer Details of Non-Contact White/Blue Light Scanning General Measurement Device and Calibration Topics 0
L Color measurements R&R: what's wrong with white? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
L BSI White Paper on Human Factors/Usability Engineering IEC 62366 - Medical Device Usability Engineering 12
MichaelDRoach Where in ISO 9001 is White Out on Forms and Records Prohibited? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Use of white-out or obliterating a portion of a controlled drawing or document Document Control Systems, Procedures, Forms and Templates 7
P EU MDD revisions white paper on the proposals for the Medical Device Regulations EU Medical Device Regulations 1
B I'm Dreaming of a White Christmas... Coffee Break and Water Cooler Discussions 31
P White Light vs. Laser Scanner - Investing in a 3d Scanner Quality Tools, Improvement and Analysis 6
V Where to find Red/White Rust Rating Requirements? APQP and PPAP 4
L Discoloration of Tin Plated Surface from White to Black or Yellow during Storage Manufacturing and Related Processes 7
AnaMariaVR2 [White Paper] Writing & Enforcing Your SOPs for GxP Compliance Success Document Control Systems, Procedures, Forms and Templates 0
R Red LED vs. White Light Inspection Lamp Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
S What's a White Paper and how is one applicable in the Medical Device field? Other US Medical Device Regulations 9
O European or Asian equivalents for white tinplate (GZHK) TU U 14-4-422-97 Other ISO and International Standards and European Regulations 3
D BIW (Body in White) 100 Grid Line picture Manufacturing and Related Processes 3
Jim Wynne Ford plans white-collar layoffs World News 3
N The Term for Black and White Art Coffee Break and Water Cooler Discussions 18
M Validation White Papers The Reading Room 1
D Zinc Phosphate problems - Green Bath has turned White Manufacturing and Related Processes 11
S How do you control White Paper Documents in Engineering OR QA? Document Control Systems, Procedures, Forms and Templates 2
Ajit Basrur Are "Controlled Rooms" or "White Rooms" referred as ISO Class 9 rooms? ISO 13485:2016 - Medical Device Quality Management Systems 3
Brizilla "Measuring the quality of white collar employees and productivity." Misc. Quality Assurance and Business Systems Related Topics 6
Marc Detroit's Big Three seek White House help World News 6
Claes Gefvenberg Why is it so hard to get white collars to visit the factory floor? Philosophy, Gurus, Innovation and Evolution 22
Q 2005 World Series - White Sox or Astros Coffee Break and Water Cooler Discussions 33
Marc Ford reduces earnings forecasts - To axe 1,700 more white-collar jobs - 2005 World News 2
D QMI White Paper, RE: AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Wes Bucey GM to Cut North American White-Collar Workers World News 28
M I am looking for some good white collar productivity articles World News 1
Marc MS Chief Security Officer to work for White House After Work and Weekend Discussion Topics 13
Marc The Use Of White-Out on Quality and Other Records Records and Data - Quality, Legal and Other Evidence 11
A Time plan for the "white print" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Marc Did You Know? - 1995 - Richard White - First person to be declared a Munition World News 0
M Ford Motor Company's Black/Gray/White Box Systems QS-9000 - American Automotive Manufacturers Standard 2
Marc IBM Joins The White Hats! After Work and Weekend Discussion Topics 0
J Disposal of White and Brown goods Decree Miscellaneous Environmental Standards and EMS Related Discussions 4
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
M Medical device package insert in EU and USA Japan Medical Device Regulations 2
A Minitab - Using the INSERT command to copy-paste text from and to a worksheet Using Minitab Software 6
A STI (Screw Thread Insert) Thread Gauge-use Before or After Insertion? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
M Insert Empty Column Using Minitab Macro Using Minitab Software 2
B Pdf expert needed - Insert current date in header Document Control Systems, Procedures, Forms and Templates 5
P For non-US manufacturors: Statement of distributor on insert/labelling US Food and Drug Administration (FDA) 1

Similar threads

Top Bottom