Hi all, :bigwave:

I have just moved to an engineering services company which has a really old fashioned QMS, totally paper based. I am planning a rehaul and am fine with most of it.

Where I am unsure however and would appreciate some guidance is in the area of process and approval sign offs. I am trying to move entirely away from paper and physical signatures but right now the company fill in forms for most steps performed and sign them off. Then after most tasks some form of QA will be performed and people sign off these same sheets and then towards the end a senior engineer will sign off a form saying they have reviewed the report and that are happy with it. So at the end you typically have up to 10 sheets of different colours which get put in different boxes and when filled get put offsite.

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. As most projects are similar it only needs to be set up once and anything unique could be just added in. One of the main reasons is to allow me get some metrics and useful outputs as I have no benchmarks for anything.

If I go this route then I don’t want to have to get physical signatures so if anyone has any ideas as to what I can do here which will also allow us to comply with ISO I would appreciate it. I am guessing maybe electronic signatures would be an option but I don’t know how this would work with excel and I don’t know much of this area either.

Apologies if this is covered somewhere, I have looked about but did not find anything specific to this issue.

Thanks in advance for your help.:thanx:

Mark.

Hi Mark:

Yes, its a very good initiative you have undertaken. :applause:

Moving to a paperless QMS is a great way of being environment friendly, and organize documentation in a more systematic manner; basically, its going 'lean'. And I am particularly an advocate of such. That is why, I constantly try to learn simple new tricks to improve systems. And dont worry, you will be more than just in line with ISO requirements, ofcourse, as long as you fulfil standard requirements.

If you are completing a process electronically, the controlling issue is almost always related to signatures, unless if you have ERP setup or a simpler networked setup, where all signatories are given unique ID's and access to control their functions.

Recently, while I was practicing my hand at Excel 2007, I learnt that you can allocate single cells to a particular person, and password protect it. This means that any other signatory or user accessing the Excel form will not be able to work on that cell, unless he knows the password. So,
1. You can allocate signature cells to the respective signatories along with a password which only they have access to.
2. Generate a unique ID or signature for each signatory which he/she will enter into the cell (as a signature) after giving the password for that cell.
3. Maintain the form on the network accessible to all relevant users

In Excel 2007 - Go to the 'Review' tab --> Allow Users to Edit Ranges --> give the relevant values as required --> protect the sheet with cell selection access.

Also, you can connect your excel sheets to an SQL server, if you have one, and allow access to all relevant users, run an SQL script and run the show. I am not the best person to ask any further on this. :)

Honestly, I have not tried the above trick in real scenario yet, so I cannot really comment how well it might go.

All in all, for developing a good paperless QMS, go slow, as not everyone is tech savvy and many still do prefer the 'old-fashioned' way. ;)

Hope this helps.

Ciao.:cool:

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

Mark,


MS Excel and what you plan should be just fine, used in tandem with your company's email system, and give you the traceability desired. Attaching the working Excel file and having users forward it "up the chain" so to speak, until final review, then have final review forward you a copy of the finished file via email. Forwarded email should show each link in the chain, for traceability.

Regards,

Joe

Thanks Sam/Joe for the feedback, I appreciate your time.:)

My goal here is to aim to have the excel file situated in a single location and have the engineers who perform the various processes access it as they complete their tasks and enter data and then somehow sign it off. A number of processes may occur in parallel so moving a single file from person to person as it needs to be updated may not be possible.

Maybe I need to take a step back and ask what exactly does ISO require in terms of evidence and approvals for processes.

Do I need “evidence” (e-mail /signature/other) for every single function performed? It is some form of proof that a certain person did a particular task on a specific date or something else? Sorry of this is pretty obvious, I am sort of new to this and my previous employer had a system which did not require any of this to be performed.

Then can I just send the completed excel file to the senior engineer for his review and get a single final approval from him/her or am I being naive... If I am wrong on my assumption please let me know, thanks.

Sam, I like your excel idea, the only hitch for me (unless there is an obvious workaround) is that I would need to include a cell for everyone in the company for every step of the process if I wanted one global template for everyone to use (another goal here) which would run into hundreds of employees. To tailor it each time for the specific project team members would require everyone to know everyone else’s password for setup. Unless I can set it up for everyone and have an option to select the team members. Even then I suppose I would need a sign off from some engineers for multiple functions which could be difficult.

Another reason for moving from paper is that our projects are cross global sites and more than one person can work on a task. If anyone has any other ideas I would appreciate them sharing with me, thanks again all.:yes:

Edit:

Just looking into options on this for excel, I found the following demo on the web which allows you to track changes on a workbook. You have an option which the demo does not cover to "List changes on a new sheet" which gives you a summary of every change made to the workbook, who did it, when etc. Is something like this enabled on the workbook I am proposing to build going to provide enough evidence to show particular individuals did certain tasks?

http://www.brainstorminc.com/cbt/microsoft/help.php?file=excel12

Maybe I need to take a step back and ask what exactly does ISO require in terms of evidence and approvals for processes.
That's a really good idea - in fact the best place to start :D Go back to the source & aim to understand that, otherwise you'll just get other people's opinions & interpretations.

IF you are talking here about document control - (clause 4.2.3)
it says "A documented procedure shall be established to define the controls needed" - ie, you define the controls needed in your organisation. You need, of course, reasonable justificaioin for your decisions.

IF you are talking about what records are mandatory (4.2.4), then see this thread (http://elsmar.com/Forums/showthread.php?t=32307&highlight=mandatory+records+9001).

Then can I just send the completed excel file to the senior engineer for his review and get a single final approval from him/her or am I being naive...
No, you're on the right track. I'd call it being simple and practical, and would encourage you to keep being both!

If I am wrong on my assumption please let me know, thanks.
nother reason for moving from paper is that our projects are cross global sites and more than one person can work on a task. If anyone has any other ideas I would appreciate them sharing with me, thanks again all.:yes:

Suggest you do a search for threads looking for electronic documentation, paperless, etc. as there have been a number of previous discussions of this. Like this one (http://elsmar.com/Forums/showthread.php?t=1675&highlight=paperless+system%2C+electronic+documentation) for example.

Thanks JaneB.:D

I don’t believe what I am trying to manage here comes under document control although I could be wrong. I am trying to determine what evidence (if any) there needs to be available as a record to prove to our auditor that functions were performed, by whom and when. Maybe it is not required and then I have nothing to worry about?

Currently through the life of a project, engineers here will typically do the following a number of times (i) analysis on data generating outputs (ii) a second will QA the work methodology and generated outputs (iii) a third (possibly the first engineer) will do any rework.

Right now every single function requires a separate physical form to be filled in. Each sheet has (i) fields for general project info, (ii) a checklist for the engineer to tick off before handing off to QA (iii) a section for the QA person to fill in their comments when they have the QA completed and (iv) a section where the engineer indicates whether the rework needs to be verified. For parts (ii), (iii) and (iv) there is a section for the person doing the task to enter (write) their initials.

Each of these forms once completed just gets filed away. I am hoping to combine them all to a single spreadsheet to improve quality and so we can get some outputs.

What I am trying to establish is that if I move all the forms to an excel sheet do I still need to have a signature, either physical/digital/other or can someone just initial the excel spreadsheet and this will serve as enough for ISO.

Thanks again.

I'd say the use of tracking changes on the Excel file would work well. You might even just have a field on the worksheet for the initials of the user who just performed work on it, with a date of action, then, as you'd noted, send off to the senior engineer for final approval. Your record of final approval could be via email, or whatever you wish. The standard is not specific on HOW you do this, but does require you to control it. It should be in a way that makes sense for your organization, or there is no benefit. Once you decide how to handle this, document it in your QMS. This DOES sound like something that you will need to be able to show traceability of review/work, but there's no reason you can't transfer all the current paper forms you mentioned for each project to an Excel sheet to track the same things. I think you're on the right track.

Originally Posted by mataylor http://elsmar.com/Forums/images/buttons/viewpost.gif (http://elsmar.com/Forums/showthread.php?p=304545#post304545)

Sam, I like your excel idea, the only hitch for me (unless there is an obvious workaround) is that I would need to include a cell for everyone in the company for every step of the process if I wanted one global template for everyone to use (another goal here) which would run into hundreds of employees. To tailor it each time for the specific project team members would require everyone to know everyone else’s password for setup. Unless I can set it up for everyone and have an option to select the team members. Even then I suppose I would need a sign off from some engineers for multiple functions which could be difficult.

Now, wait a minute, I am trying to understand something here. Why would you require, in your global template (one of your goals), a cell for everyone in the company or even hundreds of employees? :confused:As you have mentioned, just have drop down lists for your team members and their job titles/functions and things could be easier. Or no?

Originally Posted by mataylor http://elsmar.com/Forums/images/buttons/viewpost.gif (http://elsmar.com/Forums/showthread.php?p=304545#post304545)

Edit:
Just looking into options on this for excel, I found the following demo on the web which allows you to track changes on a workbook. You have an option which the demo does not cover to "List changes on a new sheet" which gives you a summary of every change made to the workbook, who did it, when etc. Is something like this enabled on the workbook I am proposing to build going to provide enough evidence to show particular individuals did certain tasks?

http://www.brainstorminc.com/cbt/mic...p?file=excel12 (http://www.brainstorminc.com/cbt/microsoft/help.php?file=excel12)

If the summary can be modified by any other user, or the data tampered with, then its probably of lesser use. I just looked at it, I could'nt find any place I could include a new member name (who). Also, after making a change, it did not appear on the screen as it mentioned.

Originally Posted by mataylor http://elsmar.com/Forums/images/buttons/viewpost.gif (http://elsmar.com/Forums/showthread.php?p=304545#post304545)

Right now every single function requires a separate physical form to be filled in. Each sheet has (i) fields for general project info, (ii) a checklist for the engineer to tick off before handing off to QA (iii) a section for the QA person to fill in their comments when they have the QA completed and (iv) a section where the engineer indicates whether the rework needs to be verified. For parts (ii), (iii) and (iv) there is a section for the person doing the task to enter (write) their initials.


Do you mean, the same form (having the contents i to iv), is used multiple times for different functions of a process? If all these personnel are located at diferent places, I can still gulp it down, else its totally out of sync, especially that the functions put in the form are in sequential order.


IMO, you should really go ahead and successfully complete this very valuable task of having such processes paperless and more controllable, despite the many obstacles. Best of luck for that! :agree1:

All in all, I recommend, after you do get some more good suggestions out here, have a prototype template made (it might take some grey cells!) in excel, and get back here. By looking at the template, things will definitely get a lot clearer and help you get the most optimized solution to your query. :)

Keep us posted on this.

Ciao. :cool:

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

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 don’t believe what I am trying to manage here comes under document control although I could be wrong. I am trying to determine what evidence (if any) there needs to be available as a record to prove to our auditor that functions were performed, by whom and when. Maybe it is not required and then I have nothing to worry about?

No, it's records.

Can I suggest that you're possibly going about this the wrong way - putting the cart before the horse, as it were?

I'd start by forgetting about having to 'prove' it to the auditor or 'for ISO'. (I know that can be difficult when you have the kind of form-heavy system you describe). Focus first on the aims and overall purpose of your system, eg, customer satisfaction and consistency.

What I'd do is:

Look at each of the processes involved.
Figure out where the CCPs are - critical control points.
Decide what evidence is required - what YOU need to capture and maintain as a business in order to maintain good management control, mitigate risk.
Then, cross-check that back against the mandated evidence in the Standard (all the required records).
ANy gaps? If you find, decide how to fill.
Then - and only then - I'd review against the current system to determine what I can get rid of.
Pilot new system, and see if in my desire to simplify, if I've actually lost anything important (eg, if only ONE sig/whatever at the end, is that adequate or do I need to capture everyone else's? If I do, why? If I don't, why?

IWhat I am trying to establish is that if I move all the forms to an excel sheet do I still need to have a signature, either physical/digital/other or can someone just initial the excel spreadsheet and this will serve as enough for ISO.

You need RECORDS. 9001 says what, but not how. You decide what format that is in - electronic or manual signature. Or even other (eg, files moved to a protected location, only accessible to certain people).[/QUOTE]

But note that I cannot see the detail sof what you're describing, and I don't know the context. (On the other hand, I just love chucking out needless complexity or bureaucracy!) I don't know the implications of not having such forms... but it's entirely likely that the 'form for everything in triplicate' is a legacy, and/or is just ONE way that someone decided to manage it. That doesn't mean it has to be done that way.

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.

Originally Posted by mataylor http://elsmar.com/Forums/images/buttons/viewpost.gif (http://elsmar.com/Forums/showthread.php?p=304636#post304636)

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. :cool:

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

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 :tg:)

No sweat Jim, I like you anyway.

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

1Husband = How

Its used as a catchy line during my presentations. :D


Ciao. :cool:

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

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

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.

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!

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

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.

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. :cool:

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

Yarik, this is sweet!