7.5.3 prod id and traceability master list of records

J

juliov

#1
I need your opinion about the following point:
I did search the cove threads about this topic but did not find the correct interpretation. Here it goes:

Clause 7.5.3 in the records required by ISO 9001 : 2000 is listed as required
I would welcome to read your interpretation of this clause as to how to show compliance, the issue I am having is what records are needed (one suggestion stated: "the unique identification of the product, where traceability is required") can you expand a bit further, any examples would help visualize the depth and breadth of this clause. I am trying to fill in the master list of records with location, filing, retention and disposition. Since there are many functions how do we address this correctly.

Thanks,
 
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R

ralphsulser

#2
Identifications we use are lot tickets placed in part containers from each process department. The lot tickets contain lot numbers, part numbers, process name, raw steel heat numbers, die numbers, barcode scan codes, etc. We can trace all parts from each process back to the steel chemical analysis report we receive with each lot of steel received. Each process also logs lot numbers coming in from the previous department, and lot numbers going out from their department, on their checksheets.
 

GStough

Leader
Super Moderator
#3
In addition to barcodes as Ralph mentioned, labels, ink stamps, sewn-in labels, etc. may also be used, depending on the product.

Our identifiers contain the product style number, production lot number and/or case ID number, which can be traced to the date, shift, and in some cases the inspector who packed the product, depending on the type of product. The application of these means of identification and traceability is documented in approved procedures.
 
T

Ted Schmitt

#4
Clause 7.5.3 in the records required by ISO 9001 : 2000 is listed as required
I would welcome to read your interpretation of this clause as to how to show compliance, the issue I am having is what records are needed (one suggestion stated: "the unique identification of the product, where traceability is required") can you expand a bit further, any examples would help visualize the depth and breadth of this clause. I am trying to fill in the master list of records with location, filing, retention and disposition. Since there are many functions how do we address this correctly.

Thanks,
We have a single number for each product assembled. During final inspection, we register this unique number and along with all of the subcomponents traceability numbers.

Ex. :

Unique Part number HA 001
Body : 12306
Bonnet : 12407
Stem : HQ
Rings : AB
Wedge : 12407
Weld on wedge : BZ
etc...

Each quality certificate we receive for the above components is verified and if approved, we write down the individual traceability number on it.

Hope this helps...
 
J

juliov

#5
Thanks for the info. How can the records in the master list of records be entered under the headings of Location, Filing, retention and disposition.
specifically who would be the records custodians? since prod id and traceability can be encountered everywhere in the plant,
thanks,
 
T

Ted Schmitt

#6
Thanks for the info. How can the records in the master list of records be entered under the headings of Location, Filing, retention and disposition.
specifically who would be the records custodians? since prod id and traceability can be encountered everywhere in the plant,
thanks,
IMO, 4.2.4 only applies to the maintenance of the traceability records and not the identification of the products...

I maintain as a record my suppliers quality certs and my Master assembly list...

Location : File cabinet in CQ
Filing : by supplier / by cert #
Retention : 20 years
Disposition : recycle
 
R

ralphsulser

#7
Thanks for the info. How can the records in the master list of records be entered under the headings of Location, Filing, retention and disposition.
specifically who would be the records custodians? since prod id and traceability can be encountered everywhere in the plant,
thanks,
This is included in our procedure for "Control of Records". Quality Control is the custodian of all the records relating to quality documents, such as check sheets, X bar & R charts. Filed in QC and after 1 year put in storage boxes identified with all the pertinent info. Then the boxes are stretched wrapped to a skid and stored in a safe palce in the plant on racks. Our procedure specifies all records will be maintained for 7 years unless otherwise specified, before disposition.( this was an edict from corporate headquarters to satisfy their requirements)
 
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