Now that you have created your SOPs, you (QA mostly) must track them and monitor them to verify that they are 1)current and 2) being used as written.
A good document tracking software is invaluable for this. If you're in a small company and just starting out, a well designed Microsoft Excel Spreadsheet will suffice for logging and tracking your SOPs. However, as your company grow and the number of procedures developed grows, you will need something like Lotus Notes, Documentum, Trackwise, QPulse or OpenText Livelink (just to name a few that I'm personally familiar with) to manage this process efficiently. There are many choices and various prices out there so do your homework and choose the software that is right for you and your budget.
First - for tracking purposes - you should have the following headings:
> SOP Title
> Date Effective
> SOP Author
> Responsible Department
> Review Due Date
> Date Submitted for Review
> **Currently Under Revision
> Date Review Completed
> Retired
For 10, 15 even 25 SOPs you might be able to track this information using a Microsoft Excel Spreadsheet. However, over the years, as your company soars on the fasttrack of success; even this number may become difficult to sort and maintain accurately and you will need a real database. You can have one built using Microsoft Access or you can purchase off-the-shelf software. Either way, I strongly recommend that you encourage your company to invest in a tracking software.
Now, I realize that QA is usually the last to be granted funds as so many CEOs and managers do not grasp the importance of QA until all hell breaks loose - but it is imperative that you help management understand that this software is important for compliance.
With the software, you will be able to document the history of each SOP and then when the company is inspected (it is never IF, but always a matter of WHEN), QA can pull the history on the requested SOP ensuring the inspector gets only the information requested and not a summary of all your SOPs history (just in case you missed updating one because that will be the one that they spot!).
Second - ask each responsible department to assign a person for the review. Communicate via email or create a form where the responsible author requests the current SOP from QA in the appropriate format for editing. If using Lotus Notes, Documentum and some of the other softwares, all edits and corrections can be done electronically. This is exceptionally advantageous in that if an employee leaves, you will know what was done and pick up where they left off. For all you MICRO-MANAGERS out there, it will also allow you to check on the individuals progress with the SOP.
QA must be diligent in alerting the department as to when a SOP is nearing it's anniversary date for revision. Most companies that I've audited are using an "every-2 years" review cycle. This can lead to trouble if you are seriously understaffed. Consider your resources and set your anniversary review date for the SOPs accordingly. I have found that "every 3 years" is more reasonable unless you have people dedicated to that function alone.
You will note that in the list above, I placed two * in front of "currently under revision". I did that because so many people fail to document when a SOP is under revision and during an audit they are cited for a SOP not being updated. Keep a record of what's currently under revision and when asked about it, you can respond intelligently.
Another area companies tend to forget is the "Does not need revision". In the "history" section of the SOP, have the department manager indicate on the copy routed to them that the SOP is current and does not need revision and maintain a copy of that page. This will validate the "last review date" and provide evidence that somebody did not sit down and falsify (OOPS!) the "last review date" column just because the FDA or a regulatory inspector was in-house.
Yes, your software should be validated - but that's another topic altogether!
Also, when choosing your review period; be it annual, bi-annual or further out, always add a (+ / -) 6 months or something of that nature. This will allow for any unforseen occurrence that might interfere with the review occurring in EXACTLY two years from the effective date and making you non-compliant.
Do not hesitate to retire SOPs that no longer meet your company's needs. Company's evolve and things changes. IMO, it is better to not have SOPs than to have SOPs and not follow them.
Your "SOPs on SOPs" should describe this process. Department heads should ensure compliance within their respective departments and QA should audit and verify that each department is following written procedures and that they are current.
Well - I've taken you through the SOP process. If you have questions, comments or feedback I would greatly appreciate it. It helps me know if I'm blogging in vain.
Until next time,
Have a QUALITY day!!!
Sarah
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