Documentation During Improvement Efforts

[gakiss2]

Quick question. Our CA form and SOP are written very specifically focused on "nonconformities". Most of the things I want to change are not incorrect as they are, just in need of improvement.

Is there any risk to using Corrective Action forms without a formal nonconformity?
Or would it be better to make a form specifically for continuous improvement actions?

'Nonconformity' is just a more specific term for 'issue'. You can really call it what you like. My preference is 'Problem Statement'.

 

[Sidney Vianna]

Or would it be better to make a form specifically for continuous improvement actions?

Why have a form for continual/continuous/continoalous Improvement?

As for using a corrective action form for CI activities, you always run the risk of a misguided CB auditor writing you up for lack of verification of effectiveness, something that is not always practicable in improvement efforts.

 

[Kurt Smith]

Why have a form for continual/continuous/continoalous Improvement?

As for using a corrective action form for CI activities, you always run the risk of a misguided CB auditor writing you up for lack of verification of effectiveness, something that is not always practicable in improvement efforts.

That is kind of my concern. And on point to my original question.

In a setting that is already currently certified iso9001 and does not have any open audit findings, how do you document major changes to your processes?

If you find yourself in the middle of a process changeover, how do you show an auditor that the changes are being controlled and documented? Corrective Actions? Continuous Improvement forms? Project Charters? I know most of this is not necessarily required. But if we expect to have one or more improvement projects going at any time, isn't it wise to have something to show what is going on at any particular time?

 

[Golfman25]

That is kind of my concern. And on point to my original question.

In a setting that is already currently certified iso9001 and does not have any open audit findings, how do you document major changes to your processes?

If you find yourself in the middle of a process changeover, how do you show an auditor that the changes are being controlled and documented? Corrective Actions? Continuous Improvement forms? Project Charters? I know most of this is not necessarily required. But if we expect to have one or more improvement projects going at any time, isn't it wise to have something to show what is going on at any particular time?

what documents are you creating now?

Say you flow chart a process and want to modify steps, so up pencil in changes to the flowchart to see if they work? Why isn't that good enough?

Or what happens a lot in our case, we want to modify a routing. We write the change on the old one, see if it works, and then load it into our computer if we decide that is the way we want to go.

 

[Kurt Smith]

what documents are you creating now?

Say you flow chart a process and want to modify steps, so up pencil in changes to the flowchart to see if they work? Why isn't that good enough?

Or what happens a lot in our case, we want to modify a routing. We write the change on the old one, see if it works, and then load it into our computer if we decide that is the way we want to go.

Makes sense. How about a small example.

We do assembly work regularly, but it isn't an everyday thing. Over the years the number of different sizes of hardware we keep in stock has grown. We have no formal system in place for keeping track of what is where, when something is running low, or how to identify one piece from another. So far we haven't had any issues of incorrect hardware used or shortages causing delays. But as we do more and more assemblies problems will be inevitable.

I want to implement some basic visual management / Kanban systems to make it clear what's what and how our stock levels are sitting. I suspect it will go into place fairly easily. But, we will still need to train our people on using the cards and make work instructions. There might be a few weeks of rollout where mistakes are made.

If I was expecting an audit soon, and I wasn't confident that everyone would be using the new system correctly in time, how would I document things to keep the auditor happy? There is currently zero detail in our manual or SOP's about how our bolts and things are organized. Do I wait to update them until the process is in place and final? Do I make a project plan to show what we are trying to do?

Obviously the best answer is to not have projects open during an audit. (and this would be a pretty quick and easy project as these things go.) But since we are pushing for some large-scale improvement in a shorter time frame, I don't want to stop everything in prep for an audit.

 

[Golfman25]

Makes sense. How about a small example.

We do assembly work regularly, but it isn't an everyday thing. Over the years the number of different sizes of hardware we keep in stock has grown. We have no formal system in place for keeping track of what is where, when something is running low, or how to identify one piece from another. So far we haven't had any issues of incorrect hardware used or shortages causing delays. But as we do more and more assemblies problems will be inevitable.

I want to implement some basic visual management / Kanban systems to make it clear what's what and how our stock levels are sitting. I suspect it will go into place fairly easily. But, we will still need to train our people on using the cards and make work instructions. There might be a few weeks of rollout where mistakes are made.

If I was expecting an audit soon, and I wasn't confident that everyone would be using the new system correctly in time, how would I document things to keep the auditor happy? There is currently zero detail in our manual or SOP's about how our bolts and things are organized. Do I wait to update them until the process is in place and final? Do I make a project plan to show what we are trying to do?

Obviously the best answer is to not have projects open during an audit. (and this would be a pretty quick and easy project as these things go.) But since we are pushing for some large-scale improvement in a shorter time frame, I don't want to stop everything in prep for an audit.

Way overthinking it. If the audit occurs in the middle of an improvement process, the auditor won't care. They will identify it as a current continual improvement process and you'll get "points" for that. I can't imaging even the worst auditors are going to audit who is and who isn't trained or using the Kanban system that isn't fully implemented.

Good auditors understand the world doesn't stop. And business as usual must continue. I don't foresee a problem. Problems will arise if you have long established process that people don't follow which causes adverse quality problems for your customers.

 

[Kurt Smith]

Way overthinking it. If the audit occurs in the middle of an improvement process, the auditor won't care. They will identify it as a current continual improvement process and you'll get "points" for that. I can't imaging even the worst auditors are going to audit who is and who isn't trained or using the Kanban system that isn't fully implemented.

Good auditors understand the world doesn't stop. And business as usual must continue. I don't foresee a problem. Problems will arise if you have long established process that people don't follow which causes adverse quality problems for your customers.

Gotcha. Thank you again.

Worst part of a small place like this being my first QM position is not having any established precedent to check against. I can't tell when I am missing things completely or way overthinking it.

 

[Golfman25]

Gotcha. Thank you again.

Worst part of a small place like this being my first QM position is not having any established precedent to check against. I can't tell when I am missing things completely or way overthinking it.

No problem. Sounds like we are in similar businesses -- Small companies making metal parts. Been down this road before.

 

[greatwhitebuffalo]

Makes sense. How about a small example.

We do assembly work regularly, but it isn't an everyday thing. Over the years the number of different sizes of hardware we keep in stock has grown. We have no formal system in place for keeping track of what is where, when something is running low, or how to identify one piece from another. So far we haven't had any issues of incorrect hardware used or shortages causing delays. But as we do more and more assemblies problems will be inevitable.

I want to implement some basic visual management / Kanban systems to make it clear what's what and how our stock levels are sitting. I suspect it will go into place fairly easily. But, we will still need to train our people on using the cards and make work instructions. There might be a few weeks of rollout where mistakes are made.

If I was expecting an audit soon, and I wasn't confident that everyone would be using the new system correctly in time, how would I document things to keep the auditor happy? There is currently zero detail in our manual or SOP's about how our bolts and things are organized. Do I wait to update them until the process is in place and final? Do I make a project plan to show what we are trying to do?

Obviously the best answer is to not have projects open during an audit. (and this would be a pretty quick and easy project as these things go.) But since we are pushing for some large-scale improvement in a shorter time frame, I don't want to stop everything in prep for an aud

For something like that I would log it in Management Review minutes, we typically do one a month before the audit (or so) to prove we have planned for the change. I also do use my CA forms for a variety of things when I can in order to consolidate things, for example, when I have a ring gage require adjustment at calibration, I will open up a "CA" for the gage and investigate past jobs to ensure the issue didn't cause any problems, log it all in the form. Have had some comments from auditors about it, but they have been positive.

 

[MrsQuality]

You can always write a process deviation and set a time limit on it. It is important to outline what you wish to accomplish and have the supporting documents listed.