Is a Procedure generally understood as 'Documented Procedure'

[db]

A procedure is the specified way to carry out a process. In many small organizations, most processes do not need a documented procedure. This is where 4.2.1 d) comes in handy (which I think is one of the most important parts of the standard). Required documentation has to include those documents determined by the organization to be necessary for the effective planning, implementation and control of its processes. If the absence of a documented procedure means you have variation in the process that leads to ineffectiveness, then a document needs to be generated. But, that document could be a work instruction rather than a procedure.

 

[Coury Ferguson]

In my opinion, if it is written, it is documented.

 

[quality person]

Re: Is a Procedure always understood as 'Documented Procedure'

hi,
not required that we need to have a document for every procedure, if it is defined and established in the organization that is sufficient as per the standard. For instance, training procedures need not be documented. However the effectiveness of the training can be measured through the records. Wherever the standard doesn't demand for a documented procedure, it is understood that procedure shall be EDIM - Established, Defined, Implemented, Maintained.

Good idea to reduce the no. of documented procedures as an objective, However all the departments holds equal responsibility for the same.

 

[somashekar]

Not a value adding goal to pursue, in my opinion. What are you going to achieve after all?

Not seriously sir .... Did you miss seeing the :wink: at the end....

But, that document could be a work instruction rather than a procedure.

Call it by any name sir, it still remains a procedure or documented procedure.

 

[howste]

How does one understand the word 'Procedure' . Do most look to see a document ... ?

I can't answer the poll because the option I choose is "It depends on the context." The poll is posted in the Documentation Control Systems, Procedures, Forms and Templates forum, so it's not specific to any standard or regulation.

As has been pointed out above, the definition for procedure in ISO 9000 states that "Procedures can be documented or not." So if the context is an ISO standard or in a standard based on ISO 9001, then the correct answer is "No" unless it says documented procedure.

However the FDA regulations in 21 CFR 820 state "Establish means define, document (in writing or electronically), and implement." In every case that a procedure is mentioned in this regulation, it says "established procedures" or "shall establish procedures." So in the case of the US FDA regulations, the correct answer is "Yes."

 

[quality person]

Hi,
The documented procedures are mandatory only for the above 6 mentioned procedures. The remaining procedures shall be documented, if the organization has specifically mentioned in their QM stating that they would be maintaining a documented procedure. Else, even if the procedure is available as a established process (defined), it meets the requirements of the ISO 9001 standard.

Thanks,
Quality6

 

[samsung]

.... Did you miss seeing the :wink: at the end....

 

[samsung]

Hi,
The documented procedures are mandatory only for the above 6 mentioned procedures. The remaining procedures shall be documented, if the organization has specifically mentioned in their QM stating that they would be maintaining a documented procedure. Else, even if the procedure is available as a established process (defined), it meets the requirements of the ISO 9001 standard.

Thanks,
Quality6

Infact the issue at hand is not whether documenting a procedure is mandatory or not, the purpose of this post, as far as I could understand, is to seek the opinions of people as to what they consider a 'document' as or what picture they frame up in their minds when they are questioned about a document (whatever, not necessarily the one relating to any particular ISO standard).

 

[Net Inquirer - 2010]

How does one understand the word 'Procedure' . Do most look to see a document ... ?

Mostly documented for consistency.

 

[Randy]

Re: Is a Procedure always understood as 'Documented Procedure'

Hi,
The ISO 9001 standard demands only for 6 mandatory documented procedures. All other procedures are documented based on the size & complexity of the organization. The remaining procedures shall be defined not mandatory to be documented. The 6 mandatory documented procedures are as follows.
1. Procedure for control of documents
2. Procedure for control of records
3. Procedure for Internal audit
4. Procedure for Corrective action
5. Procedure for Preventive action
6. Procedure for non conforming product.


thanks,
Quality6

Absolutely incorrect.

The requirement is for 6 procedures to be documented, not for 6 documented procedures.Theoretically if someone could combine all of them into 1 single document it would be acceptable and conforming to the requirements...Of course we all know that "that dog don't hunt".

As for me, the only things I look for documentation of are those things that afre required to be documented either from a specific source of because of identified need.