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Re: How can an employee know that he is using the most current version of documentati
Let's look at this situation from a cost point of view. Let's say in our company we have a thousand documents and 50 employees. And let's say the company has created this policy which states that before any employee uses a document they should check with the online Master List to ensure that they are using the most "Current" copy.
Let's say the 1,000 documents are accessed on the average of 12 times a month. So that's 12,000 events or interaction between employee and documents. And let's multiply that by 12 months for a grand total of 144,000 events for a one year period. Now let's say Document Control has created a Master List and the average time it takes for any employee to look up a document is 5 minutes. If we multiply the number of events 144,000 by 5 minutes that would work out to 720,000 minutes or 12,000 hours. Depending on how your company costs out hours at, this would be your cost to meet compliance. You can see I've used some relatively low numbers to illustrate this examples. Some interactions could easily reach a few million to billions, depending on the company. What looks like a simple act could easily become a monster.
So some of the questions would be: With 144,000 events, how would you ensure that all 144,000 events will take place? What would the cost be to the company if the wrong document was used? How many nonconformances will be issued? Correction Actions and so on. How much down time would there be when an employee finds out they don't have the most current copy? With 144,000 events, what do you think are the chances that an auditor will find a mismatch, which would result in an observation?
Other questions will arise: how do you ensure that the Master List is current? If you maintain everything in a database, who would be responsible for the integrity of a database? All it takes is a few errors in a database and the database becomes worthless. Imagine finding out that there are errors in your database, who can afford the time to go through each and every document and compare it to the database to ensure that there is a 100% match? And how many times will you have to review and check the database before that happens? I can just see it now, if someone in your company points out to your boss that there are errors in the database, guess who will have to go through the database to ensure that the database is 100% accurate?
Other questions include, how do you handle Change Control? Obsoletion of documents? Just sit down and start analyzing the possible interaction between employee and documents and you will start to get a good picture of how serious of a problem it can be or how it will impact the products or services you provide your customers. Aside from that, you will get a pretty good perspective of how Document Control works in your company.
The purpose of Document Control is to create a system that will ensure that only current version of a document should be used. If you left this up to all your employees the company would fail miserably. Document Control in this scenario is shifting their responsibility to the many employees and guess whose job is on the line when wrong documents are being used throughout the document?
You should concentrate on how you control documents in the company. You should define what is a controlled document is for your company. What is the difference between "Controlled" documents and "Uncontrolled" Documents. If you as Document Control, controls how the documents are issued then you are a lot closer to meeting this compliance. That is, Document Control must control who has access to what documents for the company. You also need to analyze how you handle Change Control and Obsoletion of a document. Start by drawing a process map of the life cycle of your documents so you can understand the whole picture. The question always in the back of the mind is what is the real impact if an employee uses the wrong document. Document Control is one of the hardest elements to maintain 100% compliance. Is there such a thing as a bullet-proof Document Control System?
Let's look at this situation from a cost point of view. Let's say in our company we have a thousand documents and 50 employees. And let's say the company has created this policy which states that before any employee uses a document they should check with the online Master List to ensure that they are using the most "Current" copy.
Let's say the 1,000 documents are accessed on the average of 12 times a month. So that's 12,000 events or interaction between employee and documents. And let's multiply that by 12 months for a grand total of 144,000 events for a one year period. Now let's say Document Control has created a Master List and the average time it takes for any employee to look up a document is 5 minutes. If we multiply the number of events 144,000 by 5 minutes that would work out to 720,000 minutes or 12,000 hours. Depending on how your company costs out hours at, this would be your cost to meet compliance. You can see I've used some relatively low numbers to illustrate this examples. Some interactions could easily reach a few million to billions, depending on the company. What looks like a simple act could easily become a monster.
So some of the questions would be: With 144,000 events, how would you ensure that all 144,000 events will take place? What would the cost be to the company if the wrong document was used? How many nonconformances will be issued? Correction Actions and so on. How much down time would there be when an employee finds out they don't have the most current copy? With 144,000 events, what do you think are the chances that an auditor will find a mismatch, which would result in an observation?
Other questions will arise: how do you ensure that the Master List is current? If you maintain everything in a database, who would be responsible for the integrity of a database? All it takes is a few errors in a database and the database becomes worthless. Imagine finding out that there are errors in your database, who can afford the time to go through each and every document and compare it to the database to ensure that there is a 100% match? And how many times will you have to review and check the database before that happens? I can just see it now, if someone in your company points out to your boss that there are errors in the database, guess who will have to go through the database to ensure that the database is 100% accurate?
Other questions include, how do you handle Change Control? Obsoletion of documents? Just sit down and start analyzing the possible interaction between employee and documents and you will start to get a good picture of how serious of a problem it can be or how it will impact the products or services you provide your customers. Aside from that, you will get a pretty good perspective of how Document Control works in your company.
The purpose of Document Control is to create a system that will ensure that only current version of a document should be used. If you left this up to all your employees the company would fail miserably. Document Control in this scenario is shifting their responsibility to the many employees and guess whose job is on the line when wrong documents are being used throughout the document?
You should concentrate on how you control documents in the company. You should define what is a controlled document is for your company. What is the difference between "Controlled" documents and "Uncontrolled" Documents. If you as Document Control, controls how the documents are issued then you are a lot closer to meeting this compliance. That is, Document Control must control who has access to what documents for the company. You also need to analyze how you handle Change Control and Obsoletion of a document. Start by drawing a process map of the life cycle of your documents so you can understand the whole picture. The question always in the back of the mind is what is the real impact if an employee uses the wrong document. Document Control is one of the hardest elements to maintain 100% compliance. Is there such a thing as a bullet-proof Document Control System?
