Is a Quality Plan a document or record?

M

mjflkitty

Hi,

quick question, is quality plan a document or a records? does it mean design plan is also a document/records?

Thanks
 

Marc

Fully vaccinated are you?
Leader
A quality plan is one or more document(s). The results from the inspections / tests in the quality plan are records.
 

Al Rosen

Leader
Super Moderator
mjflkitty said:
Hi,

quick question, is quality plan a document or a records? does it mean design plan is also a document/records?

Thanks
Both are documents. A record is a type of document.

Ref: ANSI/ISO/ASQ Q9000:2000

3.7.2
document
information (3.7.1) and its supporting medium

EXAMPLE Record (3.7.6), specification (3.7.3), procedure document, drawing, report, standard.

NOTE 1 The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof.

NOTE 2 A set of documents, for example specifications and records, is frequently called “documentation”.

NOTE 3 Some requirements (3.1.2) (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).


3.7.5
quality plan
document (3.7.2) specifying which procedures (3.4.5) and associated resources shall be applied by whom and when to a specific project (3.4.3), product (3.4.2), process (3.4.1) or contract

NOTE 1 These procedures generally include those referring to quality management processes and to product realization processes.

NOTE 2 A quality plan often makes reference to parts of the quality manual (3.7.4) or to procedure documents.

NOTE 3 A quality plan is generally one of the results of quality planning (3.2.9).


3.7.6
record
document (3.7.2) stating results achieved or providing evidence of activities performed

NOTE 1 Records can be used, for example, to document traceability (3.5.4) and to provide evidence of verification (3.8.4), preventive action (3.6.4) and corrective action (3.6.5).

NOTE 2 Generally records need not be under revision control.
 

Marc

Fully vaccinated are you?
Leader
Definitions: Document vs. Record

Yes, technically both are 'documents' as a class. Actually, a record is typically a revision controlled 'document' (e.g. a controlled form) prior to data entry.

I can't think of a way to revise a record (which is what the form or whatever is after the data is entered, {or the report is written or what ever form the output takes}) unless incorrect data was entered or the instructions were not understood and data was entered incorrectly, so I think it would be a rare case where a record was subject to revision control. I understand what 3.7.6 Note 2 says, but I can't think of an example of a revision controlled record. Maybe someone can clue me in here.

Personally, I try to keep confusion down by not referring to a record as a document. A drawing is a 'document' as well, according to the qs 9000 definition you cite, but I wouldn't give a drawing to someone and say "Take a look at this document" - I'd say "Take a look at this drawing".

I believe the QS9000 folks were a bit broad when they defined a document as 'information' - That's a pretty broad interpretation.

Webster's Definition of 'information' confuses the issue a bit more:
1 : the communication or reception of knowledge or intelligence

2 a (1) : knowledge obtained from investigation, study, or instruction (2) : INTELLIGENCE, NEWS (3) : FACTS, DATA b : the attribute inherent in and communicated by one of two or more alternative sequences or arrangements of something (as nucleotides in DNA or binary digits in a computer program) that produce specific effects c (1) : a signal or character (as in a communication system or computer) representing data (2) : something (as a message, experimental data, or a picture) which justifies change in a construct (as a plan or theory) that represents physical or mental experience or another construct d : a quantitative measure of the content of information; specifically : a numerical quantity that measures the uncertainty in the outcome of an experiment to be performed

3 : the act of informing against a person

4 : a formal accusation of a crime made by a prosecuting officer as distinguished from an indictment presented by a grand jury
Webster's definition of 'document':
Function: noun

Etymology: Middle English, from Middle French, from Late Latin & Latin; Late Latin documentum official paper, from Latin, lesson, proof, from docEre to teach -- more at DOCILE

1 a archaic : PROOF, EVIDENCE b : an original or official paper relied on as the basis, proof, or support of something c : something (as a photograph or a recording) that serves as evidence or proof

2 a : a writing conveying information b : a material substance (as a coin or stone) having on it a representation of thoughts by means of some conventional mark or symbol c : DOCUMENTARY
Webster's definition of 'record':
Function: noun

1 : the state or fact of being recorded

2 : something that records : as a : something that recalls or relates past events b : an official document that records the acts of a public body or officer c : an authentic official copy of a document deposited with a legally designated officer d : the official copy of the papers used in a law case

3 a (1) : a body of known or recorded facts about something or someone especially with reference to a particular sphere of activity that often forms a discernible pattern <a good academic record> <a liberal voting record> (2) : a collection of related items of information (as in a database) treated as a unit b (1) : an attested top performance (2) : an unsurpassed statistic

4 : something on which sound or visual images have been recorded; specifically : a disc with a spiral groove carrying recorded sound for phonograph reproduction
 
D

db

Yep, both

One way to look at it is whether the quality plan is an input or output. If I use the quality plan to do my job (an input), then it is a document. If it is an output of quality planning, then it is a record. Some quality plans may include a sign-off. As one operator is finished with their process (or part of it) they initial showing their step was completed. Now, the quality plan may be both at the same time.

Don't get too wrapped up around if the plan is a record, or a document. Just make sure the level and type of control is sufficient.
 

Ettore

Quite Involved in Discussions
db said:
Don't get too wrapped up around if the plan is a record, or a document. Just make sure the level and type of control is sufficient.
good suggestion :applause:
 

Wes Bucey

Prophet of Profit
All pretty good answers so far. If you allow me to recap:
In general usage (for Quality purposes), there are two kinds of documents - controlled and uncontrolled.

Controlled documents usually imply creation, review, revision (if any), storage, access, retention, and destruction follow a set plan ("Document Control Procedure")

Most people agree "Records" are a special type of controlled document which are not normally modified or changed once created because they represent history of some activity.

The blank "Form" used to enter data to make a "record" is simply a document which does not become a "record" until the information about an activity has been entered.

Certain kinds of records may be "updated" with additional information as part of a process. The information previously entered is not modified, EVER, but may be "amended" to reflect correction of an error. The original erroneous information is left as an "audit trail" for future improvement or correction of the process which allowed the erroneous information to be entered.

In my mind and in the minds of many others, especially regulators like FDA and FAA, it is an absolute NO NO to erase or obliterate ANY part of a record. It is, however, acceptable to amend the record with correct information, while leaving the original erroneous info.

(Some individual organizations do NOT have to follow such rigid rules because they are not subject to regulation and those organizations may make their own rules about modifying records without leaving an audit trail.)

All in all, I think the Covers have "covered" the subject.:D
 
Last edited:

amjadrana

Involved - Posts
Document or record

It was a good summation from Wes.

I would add that uncontrolled documents are those that are copied out to certain deprtments or organizations for information purpose only. It is not required to send revisions unless specifically requested at a later date. Then it is copied again as an uncontrolled document.


A Quality plan is a document that sets out a way to accomplish an objective to fulfill a part of quality system. If, however, a form is used to provide evdence of activitites carried out, then it becomes a record. For example a quality plan may contain an item to buy a computer. It is subject to revision later as two computers may be needed. But, when a form is used to record prices etc, it becomes a record.
 
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