Maintaining SOPs as Living Documents

Maintaining Standard Operating Procedures (SOPs) is a hard and largely thankless task. As a GLP-compliant facility, Kingfisher International Incorporated (KFI) has wrestled with this from Day 1. How do we make SOPs that are sufficiently detailed for the regulatory framework under which we operate, yet are useful documents for the people on the “front-line” of our studies? As a Quality Associate at KFI, I had the responsibility this year to shepherd the annual SOP review process. Below is a summary of my tribulations and some helpful tips KFI has learned through the years to make SOP maintenance and distribution a smooth and fluid process:

•    Designated Review Period: We designated January to March as our “Annual SOP Review Season!” A process known and “loved” by all employees at KFI. This designated three month period allows employees to plan for the added work that will be expected during the review period. All SOPs are reviewed biennially and those requiring review were evaluated, updated, and new training was implemented as required during this time. Trust me, we worked right up to the last day in March!

•    Preliminary review personnel are key: Once we determined which SOPs required updating, we initiated our change control procedure which began with three preliminary reviewers who assessed whether or not the SOP was still relevant or if it needed revision, and if so, they made the first stab at changes. Dividing this responsibility between three people turned out to be the most efficient way to start this task as everyone had different opinions on relevancy and required changes (three heads ARE better than one!)

I quickly learned that assigning SOPs to employees was a difficult task as there are only a select few employees that have any idea how an endoscope works or how to perform a neurological exam on a puppy! Then, I had to deal with the deep sighs and aggravated glances that my coworkers made when I submitted to them a list of SOPs they were responsible for reviewing. I joked that anyone caught muttering complaints would have more SOPs on the next step!

•    Responsibility isn’t all it’s cracked up to be: Once all SOPs were initially reviewed, I was responsible for going through every SOP and making the changes that were requested (or denying the changes, if unreasonable). I felt important and empowered accepting and denying changes made by my highly educated coworkers! I became the queen of all SOPs, until around the 40th SOP when my “throne” became littered with papers, people starting asking me where I have been, and some even suspected that I had gone mad grumbling at my screen for several days. Alas, the changes were made and summarized, three new unlucky reviewers were chosen and they were sent back out into “review-land” and the process repeated.

This second review turned out to be a very important step in the review process as small mistakes were made by accepting and rejecting changes, especially when reviewing SOP after SOP.

•    Finalizing the reviewed work: The last phase was the SOP review proper (the approval process), where individuals with “ownership” over specific SOPs were invited to revisit any changes and update the document. These people included: the originator of the SOP, Quality Systems and Test Facility Management. All were required to sign off on the final product. Any SOPs involving animal procedures were routed to our Animal Care Committee for a further welfare review and their comments were incorporated as appropriate. This part of the review was very efficient at eliminating restrictive wording within the SOP to avoid potential deviations and ensure each one meets the appropriate regulatory requirements.
For example, you wouldn’t want a SOP on how to mop to say that the mopping style must be in figure eights – Every time you scrubbed a spot of dirt, you would deviate!

•    Making the final product easily accessible to all: Finally, our Document Control Officer took over (deep sigh of relief). She spent hours printing the finalized master SOPs on brilliant salmon coloured paper in order to easily differentiate between an original SOP and a copy. She then made true paper copies to be maintained for audit purposes and “working” copies in PDF format to be maintained on our server. The working copies got “pushed” out to tablets located throughout our facilities; these tablets and ‘push’ capability has made a huge impact on the efficiency of our staff and SOP control process. Not only is finding an SOP as simple as scrolling for it through the PDF directory, but the staff are assured that the SOPs are current and are available when and where they need them. It is not uncommon to see someone performing a procedure with the tablet on the desk beside them, making sure they don’t deviate from the SOP.

I now understand why so much weight is placed on maintaining effective SOPs and why there are so many reviewers involved! One small typo could be the cause of many deviations and have the potential to affect the quality and integrity of a study. With all the things I learned this review season, I intend to re-establish my reign as SOP queen in 2016 with a new found confidence and understanding of the review, control and approval process!


Tanya New, BSc is a Quality Associate at Kingfisher International Inc.