Analytical method verification process flowchart
An analytical method verification process chart for confirming local scope, planning evidence, repeating justified work, resolving open concerns, approving local use and training users.
What the analytical method verification process is
Verification starts by confirming which method version and intended use the laboratory is actually assessing. That prevents a familiar method name from obscuring differences in sample type, equipment, materials, analysts or local instructions that may change the work needed.
The chart then puts failed or incomplete evidence on a visible path. A result that does not support local use goes to documented discrepancy handling and justified repeat work, while an unapproved conclusion goes back through scope clarification rather than becoming an informal exception.
What this flowchart covers
In this template
- Method Owner, Laboratory Analyst and Quality Reviewer lanes show who owns scope, evidence generation and approval.
- Applicable method and intended use confirmed? prevents the team from planning against an unclear version or local purpose.
- Verification evidence supports local use? distinguishes a supported conclusion from work that needs a documented repeat or reconsideration.
- Approval to use method locally? leads to a local method record and training, or escalates concerns back to planning.
When to use this template
- You are introducing an established method into a laboratory, site or operational setting and need to agree the local verification path.
- Different teams use the same method name but do not have a consistent way to record scope, evidence or approval.
- A verification outcome may require repeat work, a changed plan or an escalation rather than a simple pass-or-fail handoff.
How it works
Identify the exact method
Name the approved method version, local work instruction and intended use that the verification concerns. Link the source documents so reviewers are not comparing evidence against an assumed version.
Set the local evidence plan
Describe the verification work, materials, records and reviewers your laboratory needs for this use. Keep the approach editable rather than inserting generic performance criteria that may not apply.
Control repeat work
Define who may authorize a repeat, what must be documented after a discrepancy and when a result needs escalation. The repeat loop should show a reasoned response, not a route around a difficult result.
Complete the local handoff
Add the local method record, user communication and training steps that follow approval. If a separate document-control process owns these, link to it rather than duplicating its detail here.
Frequently asked questions
What is the purpose of analytical method verification?
The process records how a laboratory confirms that an established method is appropriate for a defined local use. The exact evidence, review and authorization should be set by the laboratory's approved procedure and the method's intended purpose.
What happens when verification evidence is not sufficient?
This chart routes the case to documented discrepancy handling and justified repeat work, then back to review. If the concern remains open, the approval decision routes it to scope clarification and a revised plan instead of treating the method as locally approved.
Can this template be used for a transferred method?
It can support the receiving laboratory's local verification activity, but a method transfer often needs additional sending-laboratory handoffs and comparison work. Use the method transfer template where those cross-site responsibilities need to be drawn.