Hi Reader, what is the worst thing you could hear if you want to help someone?
“But that would mean changing the protocol.”
Just kidding. But the struggle with changing processes is real. Luckily, I have a few tips for you.
So let’s go through where the real cost lies and how to take most of it out.
Today's Lesson: Tips for Changing SOPs
Some practical advice on how to make change happen.
Number of the Day
The longest standard operating procedure (SOP, meaning the formalized protocol used in the industry) I have heard of was 500 pages long. Many people are therefore afraid to change well-established guidelines and protocols. However, not only is the average SOP about one-tenth that length, but this particular document was also written for clinical studies. In other words, all too often, we are concerned about the wrong thing. So, let’s discuss a few tips for changing SOPs and protocols.
500
When Change Needs Approval
Before starting, ask yourself if some form of regulation is involved at all - this is where a lot of unnecessary concern comes from.
Think non-GxP bench work, how you organize a freezer, or what size box something arrives in.
Indeed, the SOPs and the associated regulatory guidelines appear daunting. However, in many cases, what you intend to change isn’t even covered by them. Secondly, as we discussed previously, you don’t need to read it all. Don’t get intimidated, rather focus on what matters to your case.
Of course, in a GMP QC lab or a GLP toxicology study, it may mean formal assessment, approval, possibly validation, training, and documentation.
However, most R&D work doesn’t fall into that category.
So, please ask yourself whether your process is genuinely GxP-controlled. Or is it just controlled or formalized internally? Is it simply a lab convention, or maybe a manufacturer’s recommendation?
Too often, we think about “regulation” in broad terms. Human samples or pharma are automatically associated with strict regulatory requirements. However, there are significant differences depending on your exact working environment. Generally, manufacturing and quality control are much more tightly regulated than R&D. Similarly, in academic labs, you might not be able to change the temperature of a freezer containing human samples, but what about all the others?
If there is a regulation, go and have a look at the actual text. There’s no need to read it all; just look at the relevant sections.
The through-line of most regulation is control and traceability, not prescription.
In academic labs, similar considerations apply. You are the master of your protocol. And if it is used lab-wide, are you sure others actually oppose changing it?
But no doubt, in some cases you might have to change an SOP. So, let’s discuss a few tips.
Never Open a Document for a Single Change
What does it mean to revise an SOP? Often, one change control, one QA review cycle, and one training event.
Importantly, that overhead is the same whether you change one line or fifteen.
I know, it might seem ridiculous, but sometimes all you need is a sympathetic ear or some inspiration from others. If you don’t have colleagues to talk to, we are here for you and sometimes the internet is too. Reddit threads like this one can be truly helpful at times. Remember, many companies do not operate efficiently, regardless of their size. This can place a huge burden on you.
Therefore, bundle changes and keep a running list of “green changes we’d make here,” and let it accumulate.
Don’t overwhelm yourself by treating each individual change separately.
Moreover, remember that every SOP has a mandatory periodic review.
At that point the document is re-approved, re-versioned, and retraining may be required regardless of whether anyone changes a word - a perfect opportunity for you.
Do What Is Necessary, Not What You Fear
This might be the single biggest time sink people impose on themselves.
You can spend weeks preparing a change-by-change justification table for a revision.
There is a plethora of helpful resources available online. Here, you can find more than 850 pages of guidance and explanations to download without logging in if you have to deal with the FDA. Moreover, consultants share advice through blogs and interviews that can be tremendously helpful.
Yet it is often perfectly sufficient to write a summary rationale.
The person requesting the change is often the process owner, so they already know why each edit is needed.
The detailed “what changed” should be visible anyway because the draft is prepared using Track Changes, giving reviewers and approvers everything they need.
In short, start simple. If more is needed, you can always increase the level of effort.
Regulation Is a Spectrum - You Might Be on the Low End
Most QMSs already contain minor, administrative, or editorial change categories.
Minor changes are low-risk modifications that don’t affect product quality, safety, efficacy, or the validated state.
This design is the materialization of my original imagination of what it must feel like to navigate regulations and SOPs… But jokes aside, once you get into it, you realize how manageable many things actually are. In the end, they were also created by other humans…
They can be implemented with minimal documentation, without validation, and without regulatory submission.
Indeed, ICH Q10 already stated that effort and formality should be commensurate with risk, and the 2023 revision of ICH Q9 made this explicit. Q9(R1) states that the degree of rigor and formality of quality risk management should reflect available knowledge and be commensurate with the level of uncertainty, importance, and complexity of the issue, and that formality is not binary but exists on a continuum from low to high.
The same applies to the “which tier?” anxiety. Under the EU rules, when the conditions for a Type IA aren’t met, the change may still be classified as Type IB unless it is specifically classified as Type II, and anything whose classification isn’t determined by the guideline defaults to Type IB. In other words, the default is the middle tier, not the top one.
Is Retraining Necessary?
The FDA’s 21 CFR 211.25 and EU GMP Chapter 2 require personnel to be appropriately trained for their assigned functions, with continuing training sufficient to maintain competence.
Neither provision requires instructor-led retraining for every SOP revision.
The choice between read-and-acknowledge and instructor-led retraining is sometimes determined by your own training SOP.
If your current SOP automatically requires high-burden retraining regardless of the significance of the change, it may be worth revisiting.
A documented, risk-based approach can reduce unnecessary training while still demonstrating that personnel are competent to perform the revised procedure.
Applying the Knowledge
This lesson should encourage you. Of course, if someone doesn’t want to drive change, they will find excuses. Nothing will change that.
Yet, for anyone with ambition, it is important to realize that discretionary tasks too often die from ambiguity, not workload.
Therefore, invest the quarter of an hour to find out (or ask the right person) what change will actually require and save the weeks of over-building.
Don’t think you have to become an expert or do everything yourself. Leverage others and use their experience, templates, and resources. Your goal is to make change happen, not simply to invest effort. If a supervisor or colleague will be involved, a quick chat can tell you a lot about what you need to prepare or prepare for (but perhaps even more importantly, what you don’t need to prepare for).
I would advise finding out three things before you make a decision:
The tier. Which internal category applies, what the risk rationale is, and whether any external reporting is triggered at all.
The evidence bar. What data or comparability assessment will be accepted as sufficient at that tier, and whether revalidation or verification is needed.
The training impact. Which training format the training SOP permits for this classification.
While you’re there, gauge how your supervisor and QA actually think about sustainability.
If they’re irritated, frame the same change as process optimization. If they’re enthusiastic, you may have far less work ahead of you.
How We Feel Today
References
Penndorf, P., 2024. Reducing plastic waste in scientific protocols by 65% – practical steps for sustainable research. FEBS Letters, 598(11), 1331–1334. doi:10.1002/1873-3468.14909.
If you have a wish or a question, feel free to reply to this Email. Otherwise, wish you a beautiful week! See you again on the 10th : )
Edited by Patrick Penndorf Connection@ReAdvance.com Lutherstraße 159, 07743, Jena, Thuringia, Germany Data Protection & Impressum If you think we do a bad job: Unsubscribe
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