Good Day All,

Instead of re-inventing the wheel :bonk: I was wondering if anyone could share with me what they use/how they handle changes to equipment settings or SOPs that need to occur during non-regular business hours when the personnel who generally create and release change notifications are not around?

We are a 24-7 operation and are starting up several new pieces of equipment and robotics techs or maintenance are having to make changes to equipment (settings beyond those originally allowed, etc.) or production increasing inspection to 100% for a short duration, etc. just to run thru a night or weekend.

We have strict rules that production operators are NOT allowed to accept verbal instructions and are struggling with how to 'easily' control these changes based on the levels of personnel available at the time.

Any thought, ideas or help would be appreciated,

Thanks Muchly,

KD

The simplest way would be to allow temporary increases in inspection by authorized employees. Just state this in your containment procedure. As for process and procedure changes, I wouldn't allow them to make the changes. I presume each process has parameters in which the techs are allowed to make changes. These have been analyzed, documented and approved for the process. Under what circumstances would a tech need to change settings beyond approved process parameters? If they can't run within the approved parameters, they should be shutting down and getting help, not changing the process so it works.

I agree with the philosophy that production operators should not accept unwritten instructions. This is a good policy and no matter what you do you shouldn't allow "fudge room" in that policy. If an authorized employee wants to make a change (within his authority), write it on the instructions and sign it.

Dave

I'm assuming that there is someone present on the off-shifts who is responsible for ensuring product quality. Could that person be responsible for OKing changes and approving either an Internal Waiver and/or Abnormal Operating Instruction?

In my last manufacturing assignment the engineers has responsibility for, and control of, this sort of change. We DID allow verbal instructions in the off hours but required the operators to enter a comment into our on-line log giving the specifics of the change being made, the reason why, and who (by name) approved it over the phone.

For more complex changes we actually logged into the plant systems from home and made them ourselves. Of course, that meant we all had laptop computers that we took home each night/weekend, adequate network connections from home, and systems at the plant that allowed outside access--not all of which are available at all plants!

We rotated a formal "on call" engineer on weekends, but did not have a formal "on call" during the week. I'm not aware of any instances where the operators couldn't get hold of SOMEONE to help, when needed.

Sometimes it got almost silly--I shudder to think how many times I took my laptop on vacations or weekend trips to make sure I could access the systems to make or approve changes! :mg:

The business we were in was pretty quality intense. We made the closures that hold diapers in place. A closure failure is an ugly situation! :ca: :bonk:

Thanks for the responses. I have to add that the equipment is NEW and is being commissioned for a NEW product for a NEW customer who wants the 24-7 proof of operation. Therefore for this equip/product only, we have current 'guidelines' but no, they are not yet fully proven or tested they are simply restrictions on what maintenance and production can do without consulting Engineering. We need to start somewhere. Unfortunately we are not totally computer reliant, especially in production, so if something goes awry, Engineering is phoned and 'verbally' provides instruction (whatever it may be). We also do not have staff here who can turn this into a controlled doc for a portion of weekends or after midnight, nor can we afford to staff them. Is there a paper version, or should I create a paper version or email (Outlook) form of the log entry mentioned?

I don't think what you have said changes the situation any. To start with, you can provide for change documentation any way you want to for internal changes. If you decide to stick with calling an engineer who gives verbal instructions which are then written onto a log or a paper napkin and used as authorization, that's fine. All you have to do is allow for what you are doing in your procedure.

What I said about increasing inspection still applies. You can allow as many upward changes as you like but someone should document (on the work order?) that it was done.

I still wouldn't allow techs to make changes outside the approved parameters but if as you say, they call an engineer and he approves it - that is fine as long as it is documented somehow. You can use whatever you like as a log which IMHO would be suitable documentation.

Dave

Thanks for the responses. I have to add that the equipment is NEW and is being commissioned for a NEW product for a NEW customer who wants the 24-7 proof of operation. Therefore for this equip/product only, we have current 'guidelines' but no, they are not yet fully proven or tested they are simply restrictions on what maintenance and production can do without consulting Engineering. We need to start somewhere. Unfortunately we are not totally computer reliant, especially in production, so if something goes awry, Engineering is phoned and 'verbally' provides instruction (whatever it may be). We also do not have staff here who can turn this into a controlled doc for a portion of weekends or after midnight, nor can we afford to staff them. Is there a paper version, or should I create a paper version or email (Outlook) form of the log entry mentioned?

Most companies allow short term changes and modifications to parameters or instructions. However, to be compliant, a few simple things have to happen. Your procedures have to allow it. They should define what amount of changes are permissable, and who can make them, and how they have to notate them. And, they have to be a reasonable, controlled process. You do not have to turn them into controlled documents first.

Thanks again all,

I do understand that my system has to allow for the changes which really is why I am asking now, I am attempting to change the system. I guess my real question was related to "what should I change my system to?". i.e. from past experience what have you all found to work and not work? I want something quick and simple for those who are here but I want it controlled enough that it is not abused and does somehow find it way back into the controlled system once Engineers and Doc Control personnel are here.

I am very interested in hearing more about the references to internal waivers or abnormal operating instructions.

Thanks

Karen-Dawn,

I can explain the way we do things if you’re interested. It may be something you can adapt to work for your company. You didn’t mention if you are registered to a standard, or if there are any customer-specific requirements to deal with – that information might help us come up with a solution for you.

If we need to make a temporary change to the way we do things (i.e. product sort, repair, or changing a process parameter), we generate a temporary operation instruction. This is basically just a temporary work instruction.

The other option might be to create some type of waiver form that waives the official operating instruction.

The key to both of these is that you need someone who is competent to assess whether the changes to the process are capable of making good product. This is why I asked if there is someone on the off-shifts who is responsible for ensuring product quality (a requirement of the TS-16949 standard and I assume ISO 9001 as well). The person who has the authority to make a judgment on the acceptability of product should be authorized to approve a Temporary Work Instruction or a Waiver.

Please post or use the Private Message feature if you have any more questions, and I’ll be glad to elaborate.