38 polls so far and going at 50% each way. Interesting ~~~
Is a Procedure generally understood as 'Documented Procedure'
- Thread starter somashekar
- Start date
S
samsung
I will not be surprised if, more or less, the same trend persists in 2020 or beyond.
I think the answer for the general perception of "Procedure = documented procedure" lies in the reasons for the need of "Documented Procedures".
You require a procedure when you are required to achieve the target through
* "following specific set of steps/people/route",
* "ensure uniformity of interpretation/implementation across time & people",
* "to investigate/review retrospectively"
* "finally, an evidence that the specific procedure is actually implemented and followed".(this may specifically relevant where product requirements, product data and decisions are to be recorded.! )
Having said that, I acknowledge that there is absolute need ensure 'optimum efficiency of the process' . This is specifically true for pharma industry.
You require a procedure when you are required to achieve the target through
* "following specific set of steps/people/route",
* "ensure uniformity of interpretation/implementation across time & people",
* "to investigate/review retrospectively"
* "finally, an evidence that the specific procedure is actually implemented and followed".(this may specifically relevant where product requirements, product data and decisions are to be recorded.! )
Having said that, I acknowledge that there is absolute need ensure 'optimum efficiency of the process' . This is specifically true for pharma industry.
I think the answer for the general perception of "Procedure = documented procedure" lies in the reasons for the need of "Documented Procedures".
You require a procedure when you are required to achieve the target through
* "following specific set of steps/people/route",
* "ensure uniformity of interpretation/implementation across time & people",
* "to investigate/review retrospectively"
* "finally, an evidence that the specific procedure is actually implemented and followed".(this may specifically relevant where product requirements, product data and decisions are to be recorded.! )
Having said that, I acknowledge that there is absolute need ensure 'optimum efficiency of the process' . This is specifically true for pharma industry.
You left one out:
To preserve knowledge...
Stijloor.
I voted No and can see after ten years how much more work we have to do.
In reading some of the posts it seems to me that ISO/TC 176 made a brave decision in recognizing the fact the many procedures are not documented.
This includes the process and task details that would insult the intelligence of a competent worker. Indeed, some of the detailed "how-to" documents may be better placed and used in a training manual than the management system.
Many users dare not criticize the documents issued by the "we know best department"
so we should help them.
Deciding what should remain in the documented management system is a great opportunity to involve the users. They can advise what needs to be documented and how (text, photo, video, diagram, flowchart etc... They can also advise what needs to be mistake-proofed and automated.
Documented management systems tend to grow documents that once may have been useful but can become redundant to workers made competent by the system's effective recruiting and training processes.
ISO 9001 includes many requirements that add documentation but no requirement to rid the system of its unnecessary documentation. Hence many poorly tended mature systems are over-documented. The idea of setting a Quality Objective against this one-way valve to streamline system documentation appeals to me.
The six orphan processes often have no natural owner. A company cannot exist without many other processes (such as marketing, designing, selling, buying, making, invoicing) but the six are often neglected in mature organizations. This is why the six processes may not even exist. ISO 9001 wisely specifies documented procedures for these processes so they can be designed, owned, nurtured and used for the improvement of the whole system.
BTW, just about everyone who travels to work follows an undocumented work instruction type of a procedure.
In reading some of the posts it seems to me that ISO/TC 176 made a brave decision in recognizing the fact the many procedures are not documented.
This includes the process and task details that would insult the intelligence of a competent worker.
Indeed, some of the detailed "how-to" documents may be better placed and used in a training manual than the management system.Many users dare not criticize the documents issued by the "we know best department"
so we should help them. Deciding what should remain in the documented management system is a great opportunity to involve the users. They can advise what needs to be documented and how (text, photo, video, diagram, flowchart etc... They can also advise what needs to be mistake-proofed and automated.
Documented management systems tend to grow documents that once may have been useful but can become redundant to workers made competent by the system's effective recruiting and training processes.
ISO 9001 includes many requirements that add documentation but no requirement to rid the system of its unnecessary documentation. Hence many poorly tended mature systems are over-documented. The idea of setting a Quality Objective against this one-way valve to streamline system documentation appeals to me.
The six orphan processes often have no natural owner. A company cannot exist without many other processes (such as marketing, designing, selling, buying, making, invoicing) but the six are often neglected in mature organizations. This is why the six processes may not even exist. ISO 9001 wisely specifies documented procedures for these processes so they can be designed, owned, nurtured and used for the improvement of the whole system.
BTW, just about everyone who travels to work follows an undocumented work instruction type of a procedure.
Hi Nancy.
I agree with you that clarity of a procedure will come across to many when in a document type. But the question is does all document type procedure have to be made a documented procedure in terms of controls needed to review / approve / change / available at point of use / legible / identifiable...
S
samsung
Yes. If something is documented, it needs to be controlled because it makes a good sense and also the standards require them to be controlled. If you take it from a different perspective, all the elements that you described need to be taken into consideration even when the procedures are not documented. Undocumented procedures are also subjected to informal reviews/changes when needed, someone approves them (or atleast not disapproves them if they provide consistent & desired results), they have to be legible (understandable for the people who use them) but virtually they aren't available at the point of use yet the people, trained on those procedures, are themselves available at the point where the procedures are to be performed.
So, in my opinion, procedures can be 'undocumented', nevertheless they shouldn't be 'uncontrolled'.
Helmut Jilling
Auditor / Consultant
I read the last 30 posts, and became weary of the conversation. This question was answered pretty clearly years ago. When the ISO 9001:2000 standards came out, there were a number of articles that helped people understand the "intent" of the changes. One particular article was written by Jack West, who I believe was the chairperson of the USA group to TAG 176. That article and several others indicated the following principles:
1. A key desire of the new standard was to get away from redundant and unnecessary documentation. The old 1994 standard began each element with the requirement to "have a 'documented' procedure..." They wanted to reduce it to beneficial documents thatw ere needed.
2. A "procedure" is any methodology or routine that is followed to perform a certain task. The routine you follow to get ready for work each morning is typically the same routine and steps. That would be a procedure, a method that is followed. The way you prepare coffee in the morning is typical the same steps and routine...a "procedure." Neither example would typically be documented, but it is a consistent methodology. It is your procedure.
3. Cl 4.2.1.d says that a company should document those routines and methods, where the document will help ensure that the process or methods are followed, and result in controlled results. For example, your method to make coffee is not documented. But, at work, if the coffee is routinely poor, with a lot of variation in taste, it might be that someone will write out a short recipe and steps (instruction) to be followed, to make the coffee more predictable and satisfying (process control). That would then be a "documented" procedure.
Thus, the intent was that a procedure is a procedure (method), whether it is documented or not. Documentation just takes it to the next level of control. It is not necessary nor intended that every single thing must be documented.
PS: I did not vote in the poll because the way the question is worded skews the answers. Yes, it is generally "understood" by many people that a procedure is a document. But, as I explained in my answer, that was not the intent, nor is it required. It is "generally understood" but in error.
1. A key desire of the new standard was to get away from redundant and unnecessary documentation. The old 1994 standard began each element with the requirement to "have a 'documented' procedure..." They wanted to reduce it to beneficial documents thatw ere needed.
2. A "procedure" is any methodology or routine that is followed to perform a certain task. The routine you follow to get ready for work each morning is typically the same routine and steps. That would be a procedure, a method that is followed. The way you prepare coffee in the morning is typical the same steps and routine...a "procedure." Neither example would typically be documented, but it is a consistent methodology. It is your procedure.
3. Cl 4.2.1.d says that a company should document those routines and methods, where the document will help ensure that the process or methods are followed, and result in controlled results. For example, your method to make coffee is not documented. But, at work, if the coffee is routinely poor, with a lot of variation in taste, it might be that someone will write out a short recipe and steps (instruction) to be followed, to make the coffee more predictable and satisfying (process control). That would then be a "documented" procedure.
Thus, the intent was that a procedure is a procedure (method), whether it is documented or not. Documentation just takes it to the next level of control. It is not necessary nor intended that every single thing must be documented.
PS: I did not vote in the poll because the way the question is worded skews the answers. Yes, it is generally "understood" by many people that a procedure is a document. But, as I explained in my answer, that was not the intent, nor is it required. It is "generally understood" but in error.
D
ddchhaya
Re: Is a Procedure always understood as 'Documented Procedure'
In ISO 9001:2008 there are six procedures with a word "documented procedures". These have been mentioned by other readers also. However, in ISO 14001 and OHSAS 18001, there is only one procedure with a mandate of "documented procedure". There are other requirements of procedures but there is no mandate for "documented procedure". This means that when we talk about procedures ISO specifies procedures which need to be documented and where there is no mandate for documentation of procedures, there can be a procedure but no documentation.
In ISO 9001:2008 there are six procedures with a word "documented procedures". These have been mentioned by other readers also. However, in ISO 14001 and OHSAS 18001, there is only one procedure with a mandate of "documented procedure". There are other requirements of procedures but there is no mandate for "documented procedure". This means that when we talk about procedures ISO specifies procedures which need to be documented and where there is no mandate for documentation of procedures, there can be a procedure but no documentation.
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