Records are a special type of document - Can anyone clarify this statement? 4.2.3

D

ddunn

ralphsulser said:
I agree with Steel on this one. Every recorded piece of informattion or data cannot possibly be validated, there is way too much. Sampling of the info can be validated.

Don't read too much into "validate". The extent and method of validation would depend on the scope of the record. Sampling may be an acceptable validation for some records. It's still validation.

Why would you not want to validate the record information?
 
S

silly girl

vinaynin said:
Again my question is which type of records are special type of documents ? ...<snip>...
I just wanted to know the intent of writing this-“Records are special type of documents” is it Records like –Trial Runs, Capability Reports etc. used for future referance and it’s retention period should have more compare to general records and also it should have distribution matrix like master list of documents.

Please guide me further.

Vinay

Vinay-

The various standards typically call out what things must be kept as records. For instance, in ISO 9001:2000 there are a number of potentially required records:

  • Management Review (5.6.1)
  • Competence, awareness and training (6.2.2)
  • Records of product realization processes and product conformance (7.1 & 8.2.4)
  • Product requirements review results and actions (7.2.2)
  • Design and development inputs (7.3.2)
  • Design and development reviews (7.3.4 - 7.3.7)
  • Supplier evaluations (7.4.1)
  • Special processes - required records (7.5.2)
  • Customer property loss (7.5.4)
  • Calibration (7.6)
  • Nonconforming product (8.3)
  • Corrective actions (8.5.2)
  • Preventive actions (8.5.3)

I may have missed a few! At any rate, each clause of the standard you follow will indicate whether there is a required record. You may also want to keep other records for your own purposes.

I hope this is helpful.
SG
 
A

alekra

silly girl said:
Vinay-

For instance, in ISO 9001:2000 there are a number of potentially required records:

  • Management Review (5.6.1)
  • Competence, awareness and training (6.2.2)
  • Records of product realization processes and product conformance (7.1 & 8.2.4)
  • Product requirements review results and actions (7.2.2)
  • Design and development inputs (7.3.2)
  • Design and development reviews (7.3.4 - 7.3.7)
  • Supplier evaluations (7.4.1)
  • Special processes - required records (7.5.2)
  • Customer property loss (7.5.4)
  • Calibration (7.6)
  • Nonconforming product (8.3)
  • Corrective actions (8.5.2)
  • Preventive actions (8.5.3)

I may have missed a few!

Hi,
I´ve attached a translation (in portuguese, sorry, but it´s only to give the complete list of the required registers) of a paper from TC 176 from ISO. You can see on page 6 the complete list of the ISO 9000 items that require records. Besides that, it depends on your procedures.
 

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A

alekra

Vinay,
- Again my question is which type of records are special type of documents ? ...<snip>...
All records are considered special type of documents, OK?

- it should have distribution matrix like master list of documents.
What do you mean? If is it necessary a master list of registers? I suggest you to do the same you do with documents, following what is written in your procedures.
 
Z

ziziy2k

Randy,

Your definition is the simplest. You have made it clear and brief.

Very accurate as well.

Ziziy2k
 
J

joelsivi

Documents are essentially living things subject to change but records provide information of historical nature or past occurances, conditions, events, etc.
 
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