By Penelope Przekop, MSQA, RQAP-GCP
There is a growing industry focus on standard operating procedure (SOP) remediation. Although outsourcing, mergers, and acquisitions have been in play for the last 20 years, these activities seem to be skyrocketing, which is creating quite a few scenarios that drive the need for SOP remediation, including, but not limited to:
- Small company undergoes due diligence audit by potential business partner or buyer and learns that its SOPs have serious gaps
- Company commits to stronger outsourcing model; its current SOPs do not reflect outsourcing
- Vendor audit by sponsor reveals serious SOP deficiencies
- Growing company self identifies the need to take SOPs to the next level based on movement into the next phase of clinical development
- Growing company has overburdened itself with an exorbitant amount of bureaucracy; an unhealthy organizational focus on documenting the process has eclipsed focus on actual product.
When faced with any of these situations, a common instinct is to do whatever possible to salvage the work that’s been done, believing that this is the most efficient approach. Makes sense, right, given how many times it’s been suggested that we not reinvent the wheel? I’m all for re-recycling; however, sometimes, repurposing processes, written content, templates, etc., can be the worst possible and most expensive approach when one factors in time, human resources, and long-term outcomes. SOP remediation can be a bit like home renovations. Sometimes it’s great to repurpose, repaint, and buy new furniture when you can to bring things up to current design standards. But in some scenarios, you look around and say, “This place just needs to be gutted. We have to start over.”
So, when it comes to SOPs, how does one know when starting over is the best way forward?
Those who refuse to accept that they don’t know what they don’t know may never know how to know when to say no to reusing documents created by folks who didn’t know what they didn’t know when they did their best to create the documents knowing what they did know. (Say that five times fast.)You get the point. That said, to further explain, I need to make the following assumptions:
- At least one leader on the team knows what they don’t know and will seek to increase their knowledge and support that approach for the entire team.
- Someone on the team fully understands what needs to be accomplished and can eloquently relay this to others.
- The team generally includes logical thinking individuals who understand that trying to tape up a bottle filled with holes is an exercise in futility, a short-term fix that will continue to dissatisfy.
The best way to explain the thought process required to determine when it’s time to scrap existing SOPs and essentially reinvent them is to start with establishing the key components needed to create successful SOPs.
3 Key Components Required For Stellar SOPs
1. Subject Matter Experts That Know The Regulatory Requirements
To even begin to develop a GxP-regulated process, one must first understand the regulatory requirements. Many times, I find that the focus is to document a process, no matter what that process may be. An understanding of what is required from a regulatory perspective is key to developing the right process aside from the aspect of putting that process in writing. It’s unwise to choose to give too much responsibility for process development to anyone who is not experienced enough to truly know and understand the regulatory requirements. This is where subject matter experts (SMEs) are key. All too often, I come across SMEs who rely too heavily on technical writers and/or quality assurance (QA) staff to tell them what is required. The QA unit should certainly serve as organizational advisors; however, the SME for each process (e.g., clinical operations, data management, regulatory affairs) should know what their requirements are; knowing this should be part of their job requirements and description.
QA organizations often assign entry-level team members to help facilitate SOP development or they are highly experienced in document control and writing rather than global regulations. They should not be relied upon to tell SMEs what the regulatory requirements are or dictate their process. Doing so also creates a situation that goes against global regulations that the QA unit be removed from operations. This is important because in most instances, that same QA unit will conduct internal process audits. If they tell you what your SOP content should be, auditing the process introduces a conflict of interest.
I’m often surprised by how little regulatory knowledge operational SMEs in our industry have, and this is a key area of focus that can improve industry quality and compliance across the board. The term expert in SME means that the person has a high level of operational knowledge regarding their area, which includes the required regulations. If they do not have that level of expertise, they may not be as qualified for their role as they should be from a regulatory perspective. This is a hard pill to swallow for some. If designated SMEs do not have regulatory expertise in their area, it’s important to add increasing that aspect of their operational expertise to their annual goals.
2. An Understanding Of The Purpose of Documented SOPs
Global regulations require that our GxP processes are documented, staff are trained to perform their assigned duties, and that quality prevails to ensure data integrity and patient safety. The basic, intended purpose of an SOP is to document how a company performs a GxP-required process in a clear, logical, and concise manner so that those responsible can read and clearly understand what they are required to do and that they will all do it consistently. Documented SOPs also provide an avenue to communicate the process to auditors and inspectors. Essentially, the SOP is a training tool for both employees and auditors and inspectors. In addition, it provides a sort of index for auditors and inspectors to understand where they might find proof (e.g., documentation, approvals, completed forms, etc.) that your process was followed.
The best-case scenario during an audit or inspection is that someone reading your SOPs can immediately understand your processes, gain a clear impression that your company has organizational expertise, and see exactly what documentation they can request to verify that your stellar process is being followed. If all of that is beautifully laid out for an auditor or inspector and you can provide what they ask for in a timely manner, you will be in great shape.
Several ways to test this are internal audits, having new operational management review SOPs for this purpose (new eyes), and enabling a culture where new employees can be open about their inability to understand processes as currently written.
3. An SOP Template That Makes The Above Elements Easy To Relay And Changes To Those Manageable
I can’t tell you how many times I come across companies that are moving to a new template. All those companies have realized through some way or another that their previous template was not ideal. Let’s learn from them and admit that the template is important. An industry standard template that regulators expect to find includes the following content sections, at a minimum:
Other sections that are industry standard and helpful to have are:
Lastly, the following elements are essential to ensure document control, which supports training, consistency, and quality, all important to regulators. Why? Because conducting our business consistently goes a long way to ensure quality across the board, data integrity, and, ultimately, patient safety.
- Approvals & Approval Dates
- Effective Date
- Associated Documents
- Revision History
The best possible SOP template is one that includes these sections and that supports consistent SOP writing. In my experience, I’ve found that the best way to do this is to find or create a straightforward template for SOP writers, whoever they are. I suggest a table format with embedded instructions. This article is not focused on SOP writing; however, it’s critical to note that when determining whether to scrap old SOPs and start over, evaluating the current template is a big part of that decision. If the current template doesn’t include some of the key elements above or support a consistent writing style, you may find yourself with the following scenario:
- Policy, scope, and responsibilities statements scattered throughout the procedure section
- Procedural steps embedded in the policy or scope sections
- Procedural steps in a section called Responsibilities
- Procedural steps without a clear indication of what role is to execute the step
- Associated documents that are either not clearly indicated or have been added to the Associated or Reference list but that are not included in the Procedural Step to which they apply
- Procedural Steps that are in an illogical order
- Procedural Steps that read like an explanatory paragraph that doesn’t seem to clearly state what exactly needs to happen, who is going to do it, and when
- And the list goes on ….
When To Start Over?
With this new insight into the three key components to a stellar SOP, the organization can assess the situation and determine if it might actually be more efficient to ensure that a fantastic SOP template is chosen, identify the GxP processes at play, identify appropriate SMEs for each, and start over.
Otherwise, you will be teasing apart, untangling, redoing, rewriting, reconfiguring, etc. SOP content that was potentially written by folks who did not fully understand the regulatory requirements, the true purpose of an SOP, what auditors and regulators are looking for, or how each SOP section should be written. Imagine having to renovate your home using all the demolished elements that were just torn out and tossed into a giant trash dump in the driveway. That sinking feeling is often how the challenge of SOP remediation feels.
Set yourself free and say goodbye to the trash dump and start fresh.
About The Author:
Penelope Przekop, MSQA, RQAP-GCP, partners with pharma and biotech companies of all sizes to develop risk-based strategic solutions for establishing (or enhancing) clinical and pharmacovigilance quality systems that support growth and ensure long-term compliance. She is a global GXP quality systems/assurance and regulatory compliance consultant with 25+ years of industry experience. Her areas of expertise include strategy development, quality systems and assurance, inspection readiness, and organizational training. She frequently conducts regulatory mock inspections and develops outcomes-based inspection readiness strategies. Przekop has held leadership positions in both Big Pharma and CROs, including Novartis, Covance, Wyeth, and Johnson & Johnson. She is the author of Six Sigma for Business Excellence (McGraw-Hill). Her book, 5-Star Career: Why You Don’t Have Yours Yet and How to Get It (Productivity Press), launches in 2020.