C
Chris Ford
Hi All,
Here's the scenario:
The staff consists of very intelligent scientists who are all very busy. They have no understanding of the quality system requirements, or a sense of document controls. They need a system that is very simple to use, that will not add a major burden to their work environment.
My Plan:
My goal is to seamlessly integrate document controls into their system. They're aware that "some things are going to change" and they're willing to deal with that. They're going to have to start assigning numbers and conducting formal reviews, then they'll need to create paper master copies of everything. They don't have funding for a Part 11 system, or the time to validate one.
I've got everything defined in a way that I believe will satisfy the requirements for a Class III, moderate concern device in a tiny company like this one. The self-service idea with the periodic review is "OK", but it'll work. They've got adequate checks and balances and the internal audits will be conducted by third-parties anyway.
A manual document control system is extremely cumbersome no matter how you slice it. I need to create a document index first.... something they can assign numbers from. But, I need to be able to see the status of those documents, the revision levels, effective dates, etc.
I also need to create a DCO index with all of the pertinent DCO information.
Both should be managed in Excel, because that's probably the easiest and will be accessible to everyone on the network.
Of course, a paper copy will have to be maintained because there are no controls in place.
When a document number is first issued, the document is considered a DRAFT. That's it's status. When it's approved, it becomes ACTIVE. It can then become INACTIVE or OBSOLETE.
If I create an index that includes the status, they technically should create a new entry every time the status changes. I feel that if they overwrite information on the index, they're going to run into serious problems during an inspection. Though, I don't want to see their document index cluttered with multiple entries for each document. I'd rather see only the most current revision for each document on the list. The only way to accomplish this is to overwrite the status, revision level, effective date, DCO #, etc as they change.
The question any auditor or investigator will ask is, "how do you know that you didn't accidentally delete something or overwrite the wrong line?"
Their only safeguard is to overwrite then reprint the list every time. I don't see how this can work for this type of company.
I can easily establish a system with all the controls necessary, but the challenge here is to make this one as seamless and transparent as possible. This company will not be manufacturing the product; they are selling the design when the PMA is approved.
I'm looking for ideas and input. I'd love to see how other people who have worked in a Class III environment would approach this scenario. I've considered hiring myself as their document control department. That's not out of the question.
Throw ideas out here... think tank... brainstorm... whatever. I can also show you what I've written so far - though it's an incredibly long document. Hey... it's their preference so I'm not knocking it! But would still love to hear what you think!
Here's the scenario:
- Very small establishment consisting of six employees, including the President.
- The staff telecommutes from remote locations.
- They are developing a Class III medical device - software only.
- They currently store all documents electronically on a remote server.
- They have no document controls in place.
- No documents have been assigned numbers.
- There is little to no revision control.
The staff consists of very intelligent scientists who are all very busy. They have no understanding of the quality system requirements, or a sense of document controls. They need a system that is very simple to use, that will not add a major burden to their work environment.
My Plan:
- Establish a very simple 4-digit numbering system with a document prefix (e.g. SOP, WI, VAL, VER, SRD, etc.).
- Establish an approval matrix appropriate for the size of the company. In this case, I've decided to establish a single reviewer/approver requirement. Author signs, then reviewer approves. Either can add reviewers/approvers at their discretion, and the President (or designate) is designated as the one required approval.
- Contain all of the associated processes in one procedure under Document Controls. This staff prefers to work with "manuals" and doesn't like the idea of having to look for additional procedures, or open multiple procedures in order to accomplish something. So, for now, this is a very long document covering the document structure, numbering, issuing numbers, document life cycle / status, revision control, review / approval, the document control process, and even deviations.
- The system will be a "self-service" system. There is no one person to assign document control tasks to. This is how they currently do things so I've elected to keep it that way.
- I've installed a check system at the end of the procedure where the President will review every third DCO processed since the last review. There is a set of criteria to verify.
My goal is to seamlessly integrate document controls into their system. They're aware that "some things are going to change" and they're willing to deal with that. They're going to have to start assigning numbers and conducting formal reviews, then they'll need to create paper master copies of everything. They don't have funding for a Part 11 system, or the time to validate one.
I've got everything defined in a way that I believe will satisfy the requirements for a Class III, moderate concern device in a tiny company like this one. The self-service idea with the periodic review is "OK", but it'll work. They've got adequate checks and balances and the internal audits will be conducted by third-parties anyway.
A manual document control system is extremely cumbersome no matter how you slice it. I need to create a document index first.... something they can assign numbers from. But, I need to be able to see the status of those documents, the revision levels, effective dates, etc.
I also need to create a DCO index with all of the pertinent DCO information.
Both should be managed in Excel, because that's probably the easiest and will be accessible to everyone on the network.
Of course, a paper copy will have to be maintained because there are no controls in place.
When a document number is first issued, the document is considered a DRAFT. That's it's status. When it's approved, it becomes ACTIVE. It can then become INACTIVE or OBSOLETE.
If I create an index that includes the status, they technically should create a new entry every time the status changes. I feel that if they overwrite information on the index, they're going to run into serious problems during an inspection. Though, I don't want to see their document index cluttered with multiple entries for each document. I'd rather see only the most current revision for each document on the list. The only way to accomplish this is to overwrite the status, revision level, effective date, DCO #, etc as they change.
The question any auditor or investigator will ask is, "how do you know that you didn't accidentally delete something or overwrite the wrong line?"
Their only safeguard is to overwrite then reprint the list every time. I don't see how this can work for this type of company.
I can easily establish a system with all the controls necessary, but the challenge here is to make this one as seamless and transparent as possible. This company will not be manufacturing the product; they are selling the design when the PMA is approved.
I'm looking for ideas and input. I'd love to see how other people who have worked in a Class III environment would approach this scenario. I've considered hiring myself as their document control department. That's not out of the question.
Throw ideas out here... think tank... brainstorm... whatever. I can also show you what I've written so far - though it's an incredibly long document. Hey... it's their preference so I'm not knocking it! But would still love to hear what you think!
