Knowledge Management: Stop Solving the Same Problems Twice

Why are we solving this again?

A team spends weeks answering a cleaning hold-time question. The evidence is reviewed, the decision is approved, and the report is filed. Six months later, another team faces a similar question. Someone remembers the answer, but nobody can quickly explain which equipment it covered or why it was acceptable.

The team may repeat work already completed. Or it may copy the conclusion into a situation the original evidence never addressed. Both outcomes point to a practical question: can the next person recover enough context to make a sound decision?

ICH Q10, section 1.6.1, describes knowledge management as a systematic approach to obtaining, evaluating, retaining, and sharing information about products, manufacturing processes, and components throughout the product lifecycle. Finding the report is one part of that work. Understanding its reasoning and limits is another.

This companion to the Knowledge Management video continues the hypothetical cleaned-equipment hold-time example from the Risk Assessment guide. The example is an educational application, not a validation protocol or a recommended hold duration.

What does the approval actually cover?

In our example, supporting work and review have led to approval of a longer clean hold time for a defined scope. That conclusion covers identified equipment, a specified cleaning process, protective covers, and the storage conditions evaluated. The applicable procedure reflects the approved limit and conditions.

A useful knowledge summary keeps those boundaries beside the conclusion. It identifies the question answered, the equipment and conditions included, the evidence supporting the decision, and any unresolved uncertainty. It also makes exclusions clear.

“Hold time approved” loses much of that meaning. Another equipment item or storage arrangement has not gained approval simply because the earlier request was successful. Preserve the conditions that make the answer trustworthy.

Give the next reviewer a usable path

A folder full of reports can contain the answer without making it easy to recover. Link the conclusion to the approved assessment and study report, including the relevant version and sections. Supporting records should remain accessible through those controlled references to people authorized to use them.

Explain which statements are supported by observations and which rely on assumptions. Was an equipment configuration evaluated directly? Was comparability justified using other evidence? Does a material question remain unresolved?

These distinctions help a later reviewer understand what could change the decision. If a report is revised or an assumption is challenged, traceability helps identify the conclusions that need another look.

Keep summaries aligned with controlled evidence and instructions. A convenient summary should help people navigate the approved position, without becoming an unofficial procedure that gives a different answer.

Use earlier learning to find the gap

A second team wants to apply the same clean hold time to equipment stored in another area. The proposed arrangement uses different protective covers and may expose the equipment to different conditions.

Compare the equipment configuration, cleaning process, protection, handling, and storage conditions with the original scope. Record what matches, what differs, and why those differences matter. The earlier work can help frame that comparison, but it cannot establish facts about conditions it did not address.

Here, the comparison reveals a gap: the original evidence does not support the proposed protection and storage arrangement. The team records the gap and determines what additional assessment or evidence is needed through its established quality processes. Until wider use is evaluated and approved, the existing authorization stays within its documented scope.

That is useful progress. The team can focus its next question and supporting work rather than starting from memory or treating a familiar conclusion as a new approval.

What leaves when experience walks out?

Sometimes the missing information is still in the building. An experienced colleague remembers why a protective cover was selected, what an earlier investigation found, or why a tempting alternative was rejected. Others may know the instruction without understanding the decisions behind it.

This person-held experience is often called tribal knowledge. When a longtime colleague retires, changes roles, or leaves, useful context can disappear. The next team may repeat an investigation, revisit a failed approach, or overlook a risk that someone already understood.

Make capturing experience part of everyday work, with time and support from the organization. Useful prompts include: What surprised us? Which assumptions did the evidence challenge? Which alternatives did we assess, and why did we reject them? What should the next team check before applying this conclusion?

Check recollections against records. Distinguish a verified finding from a memory that still needs confirmation, then route the learning through appropriate review. Some skills also need demonstration, supervised practice, and feedback. Writing down the context helps preserve it; developing the judgment to use it may require more.

Give the learning an owner

An assigned owner can coordinate maintenance of the summary and its references, working with the functions responsible for technical evidence and quality decisions. This role does not replace those functions or grant authority to approve changes alone.

Define who checks references, who assesses new information, and how updates reach the people who rely on the conclusion. Review triggers in our example might include a revised cleaning process, changed protective covers or storage conditions, or an investigation challenging an earlier assumption.

Choose a review approach appropriate to the knowledge and its use. This article proposes no universal interval. The practical aim is to notice when the basis of a decision changes and make that change visible.

Learning must reach the working process

Suppose additional work supports a wider application. Manage that change through the applicable quality processes. Updating the knowledge summary alone does not authorize operators to work differently.

The approved assessment, affected instructions, and relevant training need to align with the authorized change. The Change Control guide explores how the proposal, assessment, approvals, implementation, and follow-through connect.

Make the reviewed learning available where the next decision happens. Preserve the earlier reasoning and its applicable versions so someone reviewing a historical batch can understand the position at that time, while still finding a clear route to the current approved position.

Can someone else use what we learned?

Ask an authorized colleague who was not involved in the work to find the current conclusion, explain its limits, and locate the supporting evidence. Introduce a changed condition and ask where they would take the question. Observe where they get stuck.

This is a practical usability exercise, not a prescribed compliance test. It helps distinguish a search problem from missing reasoning, unclear ownership, or an outdated reference. Counting uploaded documents will not reveal those differences.

The ICH Q8/Q9/Q10 Questions and Answers (R5), section 5, questions 2 and 4, leaves implementation choices to the company and does not require a dedicated computerized knowledge-management system. Technology can help, but first identify the problem it needs to solve.

Start with one recurring question. Can the next person recover the answer, reasoning, evidence, boundaries, and route for review without depending on one longtime employee? Use what you learn to improve the next handover or decision.

What the guidance supports

ICH Q10, Pharmaceutical Quality System, sections 1.6 and 1.6.1, positions knowledge management alongside quality risk management as an enabler of the pharmaceutical quality system and describes managing product and process knowledge across the lifecycle. Section 3.2.3 addresses change management.

ICH Q9(R1) Annex 1: Q8, Q9 and Q10 Questions and Answers (R5), dated 30 October 2024, section 5, clarifies knowledge-management implementation choices and gives examples of information sources. Questions 2 and 4 support the implementation and technology points above.

The worked example, summary fields, ownership suggestions, interview prompts, and usability exercise are Quality Unpacked educational applications. They are not verbatim guidance, a mandatory template, or a claim that ICH endorses this approach. These sources address pharmaceutical quality; apply the requirements relevant to your product, operation, and markets, along with your approved procedures. No hold duration, sample size, or universal review frequency is specified here.