QMS Overload

[DesantisJ]

Thank you all for the help.

IF the nonconformances that the OP is referencing (that his boss wants to see a reduction in non-conformances) then no amount of paper, documents, gap analyses, audits or certification will help. IF the real problem here is that there are too many defects then the OPs references to documents and QMS things is probably just his only point of reference - given that he said that his past role was in documentation. IF so, that is all just a bunch of red herrings. We should hear from the OP on what the real problem is.

My problems are numerous, but I believe my real problem lies in the fact that there is little to no control of procedures and no quality records for me to refer back to.

by non-conformance’s do you mean defects?

In short, yes. But I also consider parts that are simply out of dimension at the detail level as a non-conformance.

With all this in mind, I believe my first course of action needs to be developing my inspection/review process. At the current moment, I have no way of knowing how often an issue repeats. I've put together a basic NCR form and log to begin catching this data.

 

[Golfman25]

Thank you all for the help.

My problems are numerous, but I believe my real problem lies in the fact that there is little to no control of procedures and no quality records for me to refer back to.

In short, yes. But I also consider parts that are simply out of dimension at the detail level as a non-conformance.

With all this in mind, I believe my first course of action needs to be developing my inspection/review process. At the current moment, I have no way of knowing how often an issue repeats. I've put together a basic NCR form and log to begin catching this data.

So it sounds to me you're some type of part manufacturer. I would caution that you don't grind the place to a halt with bunches of non-conformances, leading to corrections/corrective actions. You probably have the most bang for your buck here, but you'll need to get the leadership on-board.

 

[Randy]

But I also consider parts that are simply out of dimension at the detail level as a non-conformance

OK lesson #1....For purposes of a 9001 based QMS what we consider is meaningless, so with regards to the statement above engrave this in your memory bank.....Any non-fulfillment of any requirement is a Non-conformance, no if's and's or but's. Now what we choose to do with the Non-conformance is where the decision making and associated risk it presents in addition to the procedures we have in place to manage them comes into play.

 

[Bev D]

So it sounds to me you're some type of part manufacturer. I would caution that you don't grind the place to a halt with bunches of non-conformances, leading to corrections/corrective actions. You probably have the most bang for your buck here, but you'll need to get the leadership on-board.

I think the OP is saying that he has product non-conformances. Defects and parts out of spec - he isn’t talking about procedural nonconformances - hence the idea of improving his inspection and data collection not ‘auditing of procedures. although his background is in documents so he talks a lot about documents. They aren’t certified to any QMS standard per the OP. I think. The OP is hampered by his background and lack of Quality engineering expertise.

 

[Bev D]

Thank you all for the help.

My problems are numerous, but I believe my real problem lies in the fact that there is little to no control of procedures and no quality records for me to refer back to.

In short, yes. But I also consider parts that are simply out of dimension at the detail level as a non-conformance.

With all this in mind, I believe my first course of action needs to be developing my inspection/review process. At the current moment, I have no way of knowing how often an issue repeats. I've put together a basic NCR form and log to begin catching this data.

When all you have is a hammer, everything looks like a nail. IF your organization’s true problem is too many defects and out of tolerance parts then you have a part problem not a a documented procedure problem. Better inspection of the parts and recording of the data will help. More documents and better internal auditing won’t. You seem to be lacking in quality engineering skills: Don’t forget MSA for your inspection. Problem solving skills, Data Analysis, experimental design, error proofing, SPC, and finally FMEA & Toyota Production System.

 

[Ed Panek]

Go to the area with NC and inspect them. Talk to floor personnel.l. Get their take on it. A lot of times floor employees know the problem perfectly and deal with it daily. They dont like paper work so they naturally obsess on it. They spend hours unintentionally thinking about it. Don't waste that brainpower expense.

 

[Golfman25]

I think the OP is saying that he has product non-conformances. Defects and parts out of spec - he isn’t talking about procedural nonconformances - hence the idea of improving his inspection and data collection not ‘auditing of procedures. although his background is in documents so he talks a lot about documents. They aren’t certified to any QMS standard per the OP. I think. The OP is hampered by his background and lack of Quality engineering expertise.

Right, that's what I am taking about. You can grind the place to a halt stopping production for every little NC on parts that have been running for years. It becomes especially cumbersome if you have to correct tooling and such for each NC.

 

[Mike S.]

Right, that's what I am taking about. You can grind the place to a halt stopping production for every little NC on parts that have been running for years. It becomes especially cumbersome if you have to correct tooling and such for each NC.

I guess it all depends on the nature of the nonconformances as to whether he should "grind the place to a halt". What may be considered a "little NC" by some might have a lot of risk associated with it. Been there, done that.

 

[Bev D]

I guess it all depends on the nature of the nonconformances as to whether he should "grind the place to a halt". What may be considered a "little NC" by some might have a lot of risk associated with it. Been there, done that.

Yep I’ve some of those parts with ‘little’ NCs’ grind my Customers to a halt and cause them to abandon our product. In some cases injury and harm has resulted. OF COURSE the severity of the effect must be taken into account. Not all part NCs are created equal. I’ve so occurence rates of very severe defects cause havoc and large occurrence rates of trivial parts NCs not matter a whit. Then we must acknowledge that if the specifications are ‘estimates” the worst part problem may even be within specification and those parts that are out of specification may be perfectly fine. Seen all of these.

I think the OP could also benefit from talking to his boss more about what they are worried about. The OP has a lot to learn…

 

[Golfman25]

I guess it all depends on the nature of the nonconformances as to whether he should "grind the place to a halt". What may be considered a "little NC" by some might have a lot of risk associated with it. Been there, done that.

Of course they have been going along all these years with no QMS and "crappy" parts, so I am not convinced the the risk is there.