The end of history of confusin "DOCUMENT with RECORDS" (2000,Aug-5)
In ISO9000:2000, there will be clear definitions of gDOCUMENT and RECORDh.
But there has been a long way to arrive at the clear terminology.
1. Quotation from ISO9004:1987
It says in the clause of "17. Quality documentation and records" that;
17.2 Quality documentation
The following are examples if the types of documents requiring control: - drawing, specifications, blueprints, inspection instructions, test procedures, work instructions, operation sheets, quality manual, operational procedures, quality assurance procedures.
@
17.3 Quality records
The following are examples of the types of quality records, including charts, requiring control.
- inspection reports, test data, qualification reports, validation reports, survey and audit reports, material review reports, calibration records and quality-related cost reports.
@
This classification of documents and records is understandable.
2. A problem arised: Quotation from ISO9004:1994
It says in the clause of g17. Quality recordsh that;
17.2 @
The following are examples of the types of quality records, including charts, requiring control.
-inspection reports, test data, qualification reports, validation reports, survey and audit reports, material review reports, calibration records and quality-related cost reports..
@
17.3 Control of quality records
The following are examples if the types of documents requiring control:
- drawing, specifications, blueprints, inspection instructions, test procedures, work instructions, operation sheets, quality manual, operational procedures, quality assurance procedures.
3. Comparison with ISO9004 and iSO9004-1
The title of g17. Quality documentation and recordsh was changed to g17.Quality recordsh. Why documentation disappeared? Why did the reverse order of quality documentation and quality records occur? What happened in TC176.
The change showed that ISO9004-1:1994 had no clear idea about the difference between documents and records.
4. Clear definition of documents and records in gISO9000 for small
businesses; What to do: Advice from ISO/TC176"; issued in 1996"
The book says that essentially, documents are used to describe or control how things are to be done and capable of being revised to reflect changing circumstances.
In another part the book also says that these should not be confused with records. Records are generated as a result of some activity and are a statement of facts existing at the time and cannot be revised.
The book also says that 4.5 clause of ISO9001:1994 describes document control; record control is covered by 4.16.
These sentences make a very clear and correct definition of documents and records. I thought TC176 would have finally reached at the correct answer.
5. ISO9000:2000/CD1
First appeared a definition of DOCUMENTS in the terminology of ISO9000:2000CD1. That was "medium containing information".
But by this definition of document, the document control means to control of storage conditions and protection of media from deteriorations, etc., not to control of authorization and identifying the current version about information that media hold. How ridiculous!
Moreover, the definition said that document includes records. But requirements to control documents cannot be applied to records. Is it possible to define retention period for a document? No, it is impossible. Because document differs from records and accordingly each control requirements must be different without getting them mixed up.
ISO9001:2000 CD1 requires control of document in clause5.5.6 and control of records in 5.5.7 clause. Therefore, ISO9001:2000 CD1 and ISO9000:2000 CD1 are inconsistent about document and records.
@
6. ISO9000:2000/CD2
The definition was unchanged.
@
7. ISO9000:2000/DIS
The definition largely changed. It says "information and its supportmedium".
But still as an example of documents, records are listed. Half improved.
@
8. ISO9000:2000/FIDS
It is said to be the difference between documents and records will be clearly defined in NOTES as follows.
"document: NOTE3 Some requirements (e.g. the requirement to be readable) relate to all types of documents, however there can be different requirements for specifications (e.g. the requirement to be revision controlled) and records( e.g. the requirement to be retrievable)."
"record:NOTE2 Generally records need not be under revision control."
But still the definition in "ISO9000 for small businesses; What to do: Advice from ISO/TC176" is the best.
9. The cause of the confusion
Document has three different meanings. It is the basic cause of the confusion in these ten years.
In order to clear the difference I will call each as document A, document B and C.
Document A means information that is used to describe or control how things are to be done and capable of being revised to reflect changing circumstances.
Document B means medium, which holds information of document A or a record. But this can be divided into document A or document C.
Document C means information that is generated as a result of some activity and are a statement of facts existing at the time and cannot be revised.
This can be replaced by record.
Let's look at some of present requirements in ISO9001:1994, taking consideration of the above definition.
(1) 4.10.4 clause the 3rd paragraph
"------ associated data and documentation are available---
Some of auditors may require control of the document, because the word of "documentation" is used, But in this case, documentation means document C. So can be replaced by records.
@
(2) 4.11.2 f) clause
"asses and document the validity -----"
Some of auditors may require control of the document, because the word of "document" is used, But in this case, documentation means document C. So can be replaced by making records..
The new terminology still has problem as shown in following chart.
Document-------- ________ document
|
|_______ record
Weak points of management standards are definition of words, comparing with technical standards. Words have historical and cultural backgrounds. Can TC176 effectively deal with this word problems in future?