Control of Computer Generated (Electronic) Forms - TS 16949 Control Requirements

D

dmhillsburg

#1
Does the TS standard require revision control of all forms used in the quality system- even those computer generated? In the old ISO 9001 1194- we had all forms used on a master list by department and then each form had to have a revision and authorizing initials on it. Is this still necessary in the TS standard? Thanks!
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
I think there are some threads on this, but I tried a search and didn't find one searching titles. Let me take a closer look.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
I didn't find a specific thread, but essentially computer generated forms must be 'controlled' at least as far as content goes. Typically if you're using 'store bought' software control isn't an issue because the format and content is fixed. But if, for example, you have a database you wrote in Access and you can change the form, you have to control it. There are different ways to control those forms.

Give us some info about your system (such as are you able to change the form? Is it something like an acces database?) and we can better help with more specifics.
 

The Taz!

Quite Involved in Discussions
#4
I believe that the actual control can be accomplished with limited access and authority specified in the Procedure or Work Instruction. Limited control, even in Access, can be set by your system administrator and even in the access program. Authorized personnel have all rights, users have limited Read Only rights. This does not prevent printing of the documents.

If you are networked, you can specify that the latest rev is available in controlled subdirectories or folders on the network. Now it is up to your change control system to maintain it that way.

JMHO
 

Caster

An Early Cover
Trusted Information Resource
#5
Keep it simple

dmhillsburg said:
Does the TS standard require revision control of all forms used in the quality system- even those computer generated?
I think "control" is a good idea even if ISO/TS did not require it. I've seen too many costly mistakes from the use of stale information.

But it can be real simple for computer forms.

In an access database, just add a version control table that lists all changes, dates, approvals and ensure the current version number prints on all forms.

In Excel add a worksheet that also lists all changes, dates, approvals and again print the current rev on all forms. If anyone knows how to put a link to a rev number cell in several worksheet footers, I'd love to know how.

Purchased software just needs a reference to the current version in your master list.

Another thing we've done is to put some "weasel words" in the doc control procedure to the effect that the format of a form is unimportant, but it must contain as a minimum the fields shown in the current version. This way even a handwritten form can be used in a pinch. Some auditors scratch their heads for a bit over this one, but it has survived many audits, and more important it's so simple that people actually use it rather than find clever ways to get around it.

Good luck!
 
T

TownDawg

#6
Private Sub Workbook_BeforeSave(ByVal SaveAsUI As Boolean, Cancel As Boolean)
ActiveSheet.PageSetup.RightFooter = "Last Saved " & Date
End Sub

Private Sub Workbook_BeforePrint(Cancel As Boolean)
ActiveSheet.PageSetup.LeftFooter = ThisWorkbook.FullName
End Sub
 
T

TownDawg

#7
By the way.. on the subj of control.. I tend to think like Taz does.. control the ability to change.. to make inputs.. rather than focus on trying to have all sorts of extraordinary controls on the outputs.
 
D

DocConPolice

#8
Electronic Document Control

We had issues trying to store and control electronic versions of documents. We created a website within our intranet and it only shows the latest PDF of the document and if you have a template that you want everyone to use then post the word document of the template for them to download. We have one administrator that governs the approval process and the format of every document, me. I review content and make sure that everything is correct and then insert the PDF into our website. Now people and view the latest and greatest but cannot modify it unless they are the author or the department that it pertains to and then I send them the next revision of the document to modify changes to. Word has a great option of using markups so you can track who does what to the document and review it before you create a PDF of the document.

That is my two sence on electronic document control. I recently had my process and work area audited for ISO 9001:2000 compliance and I passed with flying colors.
 

CarolX

Super Moderator
Super Moderator
#9
Adobe also has a form feature that can allow for forms to filled out electronically, without changing the form.

Adobe can be a pretty powerful tool if you know all it's features.
 
I

IEGeek - 2006

#10
I was going to suggest the Adobe features as well. I have created some pretty great stuff (I am a little modest) with Adobe Designer and it is spectacular. The only rub was that everyone had to have the latest version of Adobe Reader to use all the fill in stuff. Now that everyone is up to par, we are enjoying our access control and the masses seem pleased.

Well worth the cost of Adobe Professional
 
Thread starter Similar threads Forum Replies Date
D Control of Computer Generated Forms - TS 16949 requirements Document Control Systems, Procedures, Forms and Templates 1
Gman2 Control of Documents and (FORMS) on a Computer Network ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
H ISO 9001:2008 Clause 7.6 Control of Monitoring and Measurement (Computer Software) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K I.T. Management in Clause 4.2.3? Control of Computer Data Backup and Access Security ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Medical Diagnostic Equipment Control Computer Repair Other US Medical Device Regulations 3
T Medical Device Manufacturer Document Control Computer System Validation Qualification and Validation (including 21 CFR Part 11) 4
W Computer Software - ISO 9001 Clause 7.6 Control of Monitoring and Measuring equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Control of monitoring and measuring devices - Computer forensics company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Control of PC (computer) based Documents Document Control Systems, Procedures, Forms and Templates 3
D Control Number for Class III and IV devices Canada Medical Device Regulations 0
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
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C UDI Questions on Control Units Other US Medical Device Regulations 6
A Quality Control Datasheets Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
M Control-self assessment Internal Auditing 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
A Prototype control plan FMEA and Control Plans 2
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
W FMEA - Current control and occurrence rating FMEA and Control Plans 3
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 1
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
A Fabric roll inspection - What type of Control Chart to use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C Monitoring and Control Instruments RoHS, REACH, ELV, IMDS and Restricted Substances 3
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 3
T Risks arising from control measures vs. ineffective control measures ISO 14971 - Medical Device Risk Management 11
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
P IQ, OQ, PQ protocol, and report templates for Distributed Control Systems in Pharmaceutical Manufacturing Systems. Qualification and Validation (including 21 CFR Part 11) 0
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
T Linking Control Plans and PFMEA's FMEA and Control Plans 3
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C 8.5.1.1 Control of Equipment, Tools, and Software Programs - Questions about the extent of control of NC programs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Q Version/Revision Control of CAD files Document Control Systems, Procedures, Forms and Templates 2
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 12
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
Z Putting back excluded rows/data points in a control chart Using Minitab Software 0
J Control Plan use on the manufacturing floor FMEA and Control Plans 4
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
D All Dimensions listed on control plan FMEA and Control Plans 10
W Need for current design or process control FMEA and Control Plans 2
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
C Corrective action for failure in documents control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10

Similar threads

Top Bottom