Moving from physical signatures to a paperless QMS - Process and approval sign offs

[Joe Cruse]

Re: Moving from physical signatures to a paperless QMS - Process and approval sign of

Does your current, paper-driven system work for you, and is it compliant to the standard?

If so, does your proposed system, using Excel to capture all the change activity, review, and all other functions that the current, paper-driven system does, complete with record of approval (this can be recorded in pretty much anyway you want it done)? If so, good. It sounds like the senior engineer is the one with authority for final approval for release of the projects; if this system works just like your current one for him (hopefully easier/better), then he can show approval in any fashion you desire, including him reviewing the Excel file after you notify him it is ready for his final review. Email notification for this would be a great way to do it, but you could always do something with electronic signatures, either using Excel or sending the file as a PDF and using Adobe's electronic signatures. A field on the spreadsheet where he can put in his initials and date of final approval could work.

As Jane noted, while this is about controlling your documentation, this is a record. Her last post is great advice for you. We don't know your processes, so it's not easy to tell you exactly what to capture. Follow the 7 points she posted and you should be covered well. It actually sounds like you have it down, and are just confused as to how to show that someone is actually doing something, because they can't put an initial or signature down on a spreadsheet. But that is not necessary. Having then initial or type in their full name, along with the date they did their action, will suffice.

 

[Sam4Quality]

Re: Moving from physical signatures to a paperless QMS - Process and approval sign of

Originally Posted by mataylor (broken link removed)

Thanks Joe.
So if I have a spreadsheet which logs all changes (see attachment for example of how the output looks ) that also contains the following info for all functions performed:

(i) Engineers tick off their respective checklists against the analysis they have performed and initial/date this,
(ii) QA personnel look at the outputs and enter their findings and initial/date this, and
(iii) Have whomever does the rework also initial/date to say any changes have been carried out.

then I am meeting ISO requirements or do we somehow have to show versions of the outputs before QA and after rework.

You mention about how I control this, is it sufficient that only those who work on the project can update the file and initial it or is more needed to be done?

On traceability that you refer to I am not sure what exactly I would need to do here. Our engineers analyse data points using modelling software which produces a load of numbers. Someone then QA’s this list of numbers and determines if they were generated correctly, per (ii) above. Their findings would be reported in the spreadsheet and initialled. Is more required. We do lots of this analysis during the project and then at the end someone writes a report based on all the results. This report is then given to the client, nothing physical in terms of a product is produced.

I saw your spreadsheet attachment and from the data within it, I would as an auditor give you a clean chit provided you evidently show that this spreadsheet is directly related to the form in question. This log gives you everything of the 5 Wives and 1 Husband!

Just ensure when you want to implement this, do mention this method of control within the relevant procedure.

Why would you require anyone who is not involved with the project to sign, approve it? IMO, only those involved and the authorized person to finally approve the form need to initial it, electronically (as the spreadsheet)

I think I will try to utilize this spreadsheet within my company too! Thanks M!

Ciao.

________________________
Sincerely, SAM
"To achieve the impossible, it is precisely the unthinkable that must be thought!"

 

[Jim Wynne]

Re: Moving from physical signatures to a paperless QMS - Process and approval sign of

This log gives you everything of the 5 Wives and 1 Husband!

What does this mean? (I don't care much for those odds, btw )

 

[Sam4Quality]

Re: Moving from physical signatures to a paperless QMS - Process and approval sign of

No sweat Jim, I like you anyway.

5Wives = Who, What, Why, When, Where

1Husband = How

Its used as a catchy line during my presentations.


Ciao.

___________________________
Sincerely, SAM
"To achieve the impossible, it is precisely the unthinkable that must be thought!"

 

[mataylor]

Re: Moving from physical signatures to a paperless QMS - Process and approval sign of

Thanks everyone for your input, I really appreciate all your time.

Taking your points Jane:
1. Each individual process is pretty similar, Analysis – QA – Rework – Verify rework.
2. The control points are (i) the QA, this must be done and be done by someone senior, not a graduate role, (ii) all rework required must be completed.
3. Evidence is (i) Whomever does the analysis signs off the checklist, (ii) Someone senior does the QA, (iii) any required rework is done, (iv) the rework is verified as complete.
4.
a. 4.2.1 will be covered by a proposal which has a project plan/wbs etc and procedures related to the analysis tasks performed.
b. By having someone senior do the QA and having rework verified I presume 7.1 (realization process and product meets requirements) is met.
c. 7.2.2, customer requirements are covered in the proposal which the client signs off.
d. 7.5.3 will be covered as all the files relating to the project will be housed in a defined folder on the network, there is a defined nomenclature for files and write access is limited to the team.
e. 8.2.4 will be an email form the final approver signing off the final report.
f. 8.3/8.5.2/8.5.3 are covered through the relevant SOPs and other documentation.
5. What I am missing in terms of records are in relation to design, as all the analysis is used to produce a report telling our clients how to build a particular structure. This is new to me as my last company has exclusions to this so I will need to read up on this and no doubt follow up again on this here and if I get as much feedback I will get it sorted.
6. I have reviewed the current forms in detail with engineers asking what every cell is used for and if it serves no purpose it is being canned. Some forms we are getting rid of 90% as the information is already contained in previous forms or serves no purpose.
7. I hope to get the spreadsheet built in the next 3 weeks and pilot it locally before introducing it globally. Some sites are going to be a hard sell so I want it pretty much finished before they see it. On the signatures, I possibly don’t need it (given the feedback I have been seeing here) but given the mindset of some engineers who sign off checklists but still hand off substandard work I think it should be kept. Also for the QA at times I have noticed junior staff are doing the QA, I don’t want this occurring so again this may act as a gatekeeper to quality.

When you say electronic, does that infer digital or does simply typing your initials suffice. The tracking facility will verify the employee also, but if that was not there (forgotton to turn on) would a simple initial do?

I believe the implications of not having the forms will be (i) reduced costs, (ii) less time spent updating forms/records at each stage and filling in of repetitive data, (iii) I will get the right employees doing the right functions (iv) a medium which can provide metrics/reports, so all good!! I don’t foresee any negatives.

Joe, the current paper system works and is compliant but it is difficult to see changes week to week and from one analysis to another. Also they are badly designed with large excesses of information requested.

You are right in your assumption, I was concerned about how to provide evidence of something being done and by whom.

Sam, glad you liked the spreadsheet. I will come back and share the final product once completed. Hopefully it may help other.

 

[JaneB]

Re: Moving from physical signatures to a paperless QMS - Process and approval sign of

Some forms we are getting rid of 90% as the information is already contained in previous forms or serves no purpose.

That's what I'm guessing too. Someone created forms... and they keep getting filled in and filed, but if they really serve no purpose/duplicates, they can go. But do check the requirements for design records.

If you're getting rid of needless info recorded - wonderful!! That's why I advised you to check what is needed and 'important', rather than 'everything that's in the current paper system'. Sometimes people create these systems and make them needlessly complicated, rather than doing the steps I listed.

When you say electronic, does that infer digital or does simply typing your initials suffice.

Really depends ... sorry! If anyone at all can go in and change the spreadsheet, how is that controlled? But if you can design a reasonable system with reasonable controls, entries into an e-file can be fine. We're talking records here - up to you to determine how to record and store them.

The expected benefits you list are all excellent!

 

[xplr8n]

Re: Moving from physical signatures to a paperless QMS - Process and approval sign of

Good Discussion/thread!

I am managing the same effort with a different approach:
my document-less (reduction, if not elimination) enabled by ERP
Valid signatures = wanded ID badge and password
Validation via downstream QM online/realtime
CAPA of the System comes where a rubberstamp of NCM triggers an alarm at the down stream node (next process step)
All captured and recorded realtime, and Data backed up in 6hr increments
All steps/QMS Reqts/checks/records and the accompaning training/KB accessable with a mouse click at the POU (Point of Use)

Did all this to better my odds of compliance with great but non-complient people...also tried to reduce my day to day "cat-chasing" infavor of CPI.

For what its worth

 

[shocked]

Re: Moving from physical signatures to a paperless QMS - Process and approval sign of

Great discussion, I'm also dealing with similar paperless systems.

I've had numerous audits of my Quality Complaint system which uses a form for the individual complaint and a log to track status. my form is divided into sections and those sections are completed by the responsible parties, the form is emailed back to me (QMR) as I'm the gate keeper. Once the senior offical has "signed off", I file the form in our quality directory on the server. only a couple people have access to this directory.

"Signatures" are typed into specific cells on the section and responsibility and are backed up by email which are archived. The log is readonly and public so most employees can see what's going or the status of individual issues.

I'm currently investigating ways of using MS Outlook to automate and track-to make a good system even better. But, need an SQL server to take it to the next level. Unfortunately, the server upgrade keeps getting delayed.

 

[Yarik]

Re: Moving from physical signatures to a paperless QMS - Process and approval sign of

Hi Mark,

What I would like to do is create a single .xls spreadsheet to house all project function information, each step/function would have a separate tab. Per function the analysis work, the QA and the rework would be on a single tab. Then for senior review and sign offs there would be another.

If you still are considering going for signatres in Excel workbook... and if you want

• to have some level of protection against "signature forgery" (intentional or accidental),
• to avoid a burden of maintaining additional password for every person whose signature might be required,
• to avoid exposure of all those passwords to you (or whoever would be responsible to maintain the workbook),

here is a relatively simple alternative to using Excel's built-in workbook protection features:

You can write a simple "embedded" VBA script that would make sure that certain cells don't allow any user to enter anything else but the user's own Windows account name (i.e. the name used to log in into Windows).

In other words, anybody could "sign" any of those cells by entering their own names. So, as long as nobody can log in into Windows using somebody else's name, these "signatures" cannot be forged.
​

This trick is not perfect. It has certain obvious drawbacks (for example, anybody can remove somebody else's "signature"). But the cost/benefit ratio of this trick might be quite reasonable, at least for some organizations.

If you (or anybody else) is interested, I am attaching a sample workbook that demonstrates this technique.

FULL DISCLOSURE: I've come up with this idea (and created this samlple) while reading this thread. It means that I did not test it in any real working environment. So please use it at your own risk.

 

[somashekar]

Re: Moving from physical signatures to a paperless QMS - Process and approval sign of

Anyone here has used the 'Master Control' Quality suite ... ? I guess it has all the requirements built in. Looking for user's feedback.