Information Gathering Documents and Document/Record Control Requirements

[thekellyg]

We are going to start putting a 'Machine Run Parameters' sheet in all our production packages that go to the floor. Once every two hours, the machine operator will write down the current machine parameters such as heat, extrudate temp etc. I am gathering this data to eventually develop a BKM for any particular product type. Does this document need to be controlled? I'm thinking yes as it will be a record of each particular job and the conditions under which the product was produced but wanted the thoughts of the Cove.

Thanks in advance!!

 

[Mikishots]

Are you operating under any statutory, regulatory, customer or standard requirements? You haven't mentioned anything. If not, you're not obligated to control anything; you would keep records as you see fit.

 

[thekellyg]

Sorry for the omission Mikishots! We are working toward ISO certification and are a custom profile extrusion company.

 

[PaulJSmith]

Yup, pretty much what Mikishots said. If there is no customer/contractual or regulatory requirements for such records (if there was, you'd already be keeping them, right?), then it's your own internal procedures that would govern whether or not you need to control them. ISO 9001:2008 clause 4.2.1 leaves a vast leeway in that area.

 

[hogheavenfarm]

We did something similar at an extrusion facility I was at, we recorded the puller speeds, various front and rear extruder temps, extrudite weight, etc as well as a standard sample with key characteristics every hour. While we didn't control the form itself, the record became a controlled item and was filed with the job, as well as being used to optimise the setup for the next run. It was a fairly well documented SPC project and it worked very well.

 

[John Broomfield]

thekellyg,

Yes, make the record and keep it so you can use it.

But do not expect ISO 9001 to tell you explicitly.

Clause 7.1d feeds into 4.2.4 though. So if this record is planned then you may be asked to retrieve it.

John

 

[thekellyg]

Thanks everyone for your guidance! Next phase question, once the completed form is returned from Production, can I scan the hard copy into my Records section with a unique ID for retrieval and shred the hard copy? We will utilize it in much the same manner mentioned by hogheavenfarm, to optimize future setups. I appreciate everyone patience and input on what may be very simple questions but my previous experience has been within a large company where everything was already established. Currently, I'm tasked with setting up and implementing an entire system on my own.

 

[John Broomfield]

Thanks everyone for your guidance! Next phase question, once the completed form is returned from Production, can I scan the hard copy into my Records section with a unique ID for retrieval and shred the hard copy? We will utilize it in much the same manner mentioned by hogheavenfarm, to optimize future setups. I appreciate everyone patience and input on what may be very simple questions but my previous experience has been within a large company where everything was already established. Currently, I'm tasked with setting up and implementing an entire system on my own.

thekellyg,

Yes, provided you can rely on the back-ups of your electronic information.

BTW, you could be working with your process owners in developing your process-based management system.

John

 

[thekellyg]

Thanks John, I was pretty confident I could but if I have any doubt, I come to the Cove! Our server is backed up every night to tape and I'll probably keep the hard copies for a month or so just to be safe.

As far as process owners go, that is a LONG story. The Quality Manager here is the only other person who has ANY knowledge of ISO requirements and we are battling a half century of mom/pop "quality isn't important" culture with many production/maintenance people having been here over 30 years.

I use the analogy of: "How do you eat an elephant? One bite at a time." I figure I'm about 25% of the way up the little tuft of hair on the tail and the elephant eats a lot every day.

 

[Mikishots]

Yep, subclause 4.2.4 makes no mention of what format the records are to be in. As long as they are identified, protected and can be readily retrieved, you're good to go.