Document Control vs Continual Improvement

P

pmgeens

#1
Hi All,

Just had an email pointing out that our complaints form contains some misleading information which has resulted in it being filled out incorrectly.

This got me thinking - do you think its sufficient to log this as a document change via our document control process only, or would anyone be tempted to log it as a continual improvement/corrective action too? Seems a shame to duplicate information but where does one draw the line in low level cases such as this?!

It's difficult to define a level of importance in such cases, as this seems quite a subjective area. Any ideas?

Many thanks!
 
Elsmar Forum Sponsor
#2
Before you do anything, do you have any description of what "correctly" is? It might be easy to diagnose the "form is wrong", but it should have gone through some type of review and approval by someone beforehand. Is it now someone's opinion that the process - and form - is now wrong?

Once you've determined what the real issue is, the relevant action can take place.
 
P

pmgeens

#3
Thanks AndyN,

It's an electronic form which should say "once completed please sign and submit this form" . This would forward the details to quality who would investigate/resolve/closeout the issue with the appropriate head of section (as per our complaints procedure).

However, the form said "once resolved please sign and submit this form" so it wasn't reaching quality for resolution in the first place as users were just entering the initial details and saving rather than submitting! Simply a poor choice of wording on the form in this case. The jump from paper to electronic format was recent so teething problems are inevitable I guess!
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
Very often an email like that would generate a corrective action, including the immediate action of a document control change to update the text in the form.

Some would disagree, saying "A corrective action is too much effort for such a small issue." But you have described teething problems involved with moving from paper to electronic format. Since part of a corrective action's response is a review of what else could be effected by the same issue, it makes sense to use the process now and find other errors so they can be fixed without risk of expense at worst, or at least the added hassle of this kind of reaction to an email notifying you of one mistake at a time. You can also use it to show internal communications are effectively received and responded to, and that corrective actions are done for more than audit findings.

I hope this helps!
 

Jim Wynne

Staff member
Admin
#5
Thanks AndyN,

It's an electronic form which should say "once completed please sign and submit this form" . This would forward the details to quality who would investigate/resolve/closeout the issue with the appropriate head of section (as per our complaints procedure).

However, the form said "once resolved please sign and submit this form" so it wasn't reaching quality for resolution in the first place as users were just entering the initial details and saving rather than submitting! Simply a poor choice of wording on the form in this case. The jump from paper to electronic format was recent so teething problems are inevitable I guess!
What do you mean by "electronic form"? How does an electronic form get "signed"? If it's a PDF or Word document, you should be able to highlight the fields that need to be filled out by the user, and just say "Please complete the highlighted fields and [submit, return, whatever]."

As far as how to classify the situation, as Jennifer suggests this could be a growing pains case and it might be helpful to document it and make sure that people are aware of the issue. Before there can be a nonconformity (hence corrective action) there has to be a requirement, so classifying this as an NC probably isn't appropriate. Be less concerned with what you call a thing than with what the thing accomplishes.
 
P

pmgeens

#6
Thanks for all your comments. I think I'll go for the corrective action in this case as I agree that it could impact other forms so a wider review is necessary. I'm not going to get too bogged down with this particular case in point but just thought I'd see what the general perception was in this area, so thanks for all your thoughts.

The form is an InfoPath form which utilises digital signatures and there's fairly complex workflows going on behind the scenes via SharePoint to make sure submitted forms end up with the right people. In this case, bad design was interrupting the workflow but all is well now!

Many thanks
 
#7
Was this issue discovered by your internal audits? I'm wondering why such a change to the QMS hadn't been audited - and hence this issue elevated for attention - unless your post is as a result of an internal audit.(?)
 
P

pmgeens

#8
The issue was noticed by the quality department as the complaint library contained unsigned complaint forms. This is a brand new procedure and as such has not yet been audited.

However, the implementation of electronic forms is seen as a significant change to the QMS and as such our change control process was followed. The above problem will of course form a part of the change control review and closeout.
 
#9
A good reason to get out and audit something! When it's "new" or "changed". You might also want to take a look at the motives behind your internal audit scheduling...:yes:
 
K

kgott

#10
Hi All,

Just had an email pointing out that our complaints form contains some misleading information which has resulted in it being filled out incorrectly.

This got me thinking - do you think its sufficient to log this as a document change via our document control process only, or would anyone be tempted to log it as a continual improvement/corrective action too? Seems a shame to duplicate information but where does one draw the line in low level cases such as this?!

It's difficult to define a level of importance in such cases, as this seems quite a subjective area. Any ideas?

Many thanks!
If a problem has been identified in the document you can simply fix it and leave it at that and you can use it as an example of low level improvement or correction if you are looking for examples to use for these actions.

Of greater concern is that your process requires nonconformances to be brought to the attention of the QA person not the process owner first with a link to the QA office. Perhaps you might like to consider keeping NC within the process concerned.
 
Thread starter Similar threads Forum Replies Date
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Control of downloaded document copies by employees Document Control Systems, Procedures, Forms and Templates 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
O Vendor vs Engineering Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A ISO9001:2015 Document control and training aids ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Document Control Software Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Document Control - Revision Number in Document Names Document Control Systems, Procedures, Forms and Templates 4
I First Time Implementing Document Control for ISO-9001 - how far back do you go? Document Control Systems, Procedures, Forms and Templates 15
I Document Control Workflow Document Control Systems, Procedures, Forms and Templates 2
D ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions Document Control Systems, Procedures, Forms and Templates 51
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
B Referencing to Supplier Outputs within our Document Control System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Sidney Vianna IAF Mandatory Document #23 - Control of CB Franchisees and Agents Registrars and Notified Bodies 3
C Document Control - old revision vs new revision Document Control Systems, Procedures, Forms and Templates 22
D Software for advancing with Document Control Quality Assurance and Compliance Software Tools and Solutions 4
L IATF 16949 Cl. 7.1 - Lotus Notes for Document Control IATF 16949 - Automotive Quality Systems Standard 0
A Removing purchase order form from document control - should it be done? Document Control Systems, Procedures, Forms and Templates 9
I Video under Document Control SOP ISO 13485:2016 - Medical Device Quality Management Systems 2
S Change Control Form vs. Document Change Notification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Document control for tooling drawings (Document control clause 7.5.3) IATF 16949 - Automotive Quality Systems Standard 5
J Document Control Newbie - Control of Nonconforming / Returns Log AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
P Document Control - Do hard copies of documents need to be signed? Document Control Systems, Procedures, Forms and Templates 3
R External Standards List (Document Control) Document Control Systems, Procedures, Forms and Templates 3
M Retiring documents in Document Control Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
M Cross Function Process Map for Document Control Process Maps, Process Mapping and Turtle Diagrams 3
0 How to deal with resistance to GDP Document Control Discipline Document Control Systems, Procedures, Forms and Templates 7
dubrizo Restructuring Document Control Numbering System Document Control Systems, Procedures, Forms and Templates 3
G Migrating to an ISO 13485:2016 Compliant Document Control System ISO 13485:2016 - Medical Device Quality Management Systems 6
E Document Control MS Access Database Document Control Systems, Procedures, Forms and Templates 42
S Looking for Document Control Templates Document Control Systems, Procedures, Forms and Templates 1
S Document Control Guidelines in Engineering Projects - Excel sheets with VBA coding Document Control Systems, Procedures, Forms and Templates 3
E Challenges in document control, revisional control, and change control Document Control Systems, Procedures, Forms and Templates 8
tony s Performance Indicators for Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
M Document Control Management - External documents flowed down from customers Document Control Systems, Procedures, Forms and Templates 2
T Document Control of FMEAs and Control Plans FMEA and Control Plans 5
T Is there a difference between form control and document control ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
x-files Proper Document Control Requests Document Control Systems, Procedures, Forms and Templates 1
D Nonconformance on document control - Unapproved document on production server Document Control Systems, Procedures, Forms and Templates 4
M Where does Document Revision Control Start? Rev 0 or Rev 1 Document Control Systems, Procedures, Forms and Templates 19
I How to build a Microsoft Access MDB Database for Document Control Document Control Systems, Procedures, Forms and Templates 6

Similar threads

Top Bottom