Compliance & Accreditation · September 10, 2026
Blood Bank SOP Revision History for NABH
A blood bank SOP revision history should show which procedure changed, what changed and why, who prepared, reviewed and approved it, when the new version took effect, and what happened to every superseded controlled copy. Where your quality system requires acknowledgement or training after a change, the same trail should identify the affected staff record. NABH document-control requirements support this trace through approval before issue, identification of revision status, availability of current documents and prevention of unintended use of obsolete versions.1
Keep the current SOP, master document list, revision record, distribution or withdrawal evidence and any staff-action record connected by the same document identifier and version. Your quality manual and SOP-control procedure should define how those records fit together.
What the revision-history record should show
The revision table is an index to the evidence, not the entire evidence file. NABH sets the document-control outcomes; your centre must define the fields, responsibilities and approval route that produce those outcomes consistently.1
| Field | What it establishes | Example entry |
|---|---|---|
| Document title and identifier | Links every record to one SOP | TTI Testing, BB-TTI-04 |
| Revision or version | Separates the live copy from earlier copies | Revision 06 |
| Change summary and reason | Explains the scope and trigger | Reagent worksheet reference updated |
| Prepared or revised by | Answers who made the change | Name, designation, signature and date |
| Review and approval | Shows the authorised checks | Reviewer and approver details |
| Approval, issue and effective dates | Shows the order of control events | Approved 12 July; effective 15 July |
| Superseded version | Identifies the predecessor | Revision 05 |
| Distribution and withdrawal reference | Links issued and recalled copies | Document-control log DC-118 |
| Staff-action reference | Links acknowledgement or training where required | Briefing record TR-072 |
Do not make an approver’s signature answer two different questions. If the assessor asks who changed the procedure, a page showing only who approved it leaves the change author unidentified. Record the preparer or reviser separately, using the roles permitted by your approval matrix.
Define “issue date” and “effective date” in your document-control SOP if your centre uses both. Approval should be complete before the controlled version is issued, and the dates should make that sequence visible.1
How an assessor follows one revised SOP
Suppose an assessor selects BB-TTI-04 from the work area. The displayed version should match the master document list; its revision row should lead to the signed approval; the distribution record should show where that version went; and the withdrawal record should account for the previous version. If staff action was required, the revision should also lead to the relevant acknowledgement or training record.
The trace therefore runs in a fixed order: record the reason for change, complete the required review and approval, release the current version, withdraw the superseded version, and record staff action where your system calls for it. This order supports the NABH controls on approval, revision status, availability and obsolete documents.1
Connect live and obsolete copies
A master list marked “Revision 06 current” is only one part of the trail. The assessor may ask what happened to Revision 05, whether a printed copy remained at a bench, and how you prevented staff from opening the old file. NABH document control requires obsolete documents to be protected from unintended use when they are retained.1
For paper copies, your distribution log can identify the controlled copy number, location, holder, issue date and withdrawal confirmation. A statement saying “all old copies removed” is weak when there is no list of the copies that were issued.
For electronic SOPs, remove the superseded version from the live location and preserve it in a clearly controlled archive if your procedure requires retention. An old PDF left in a shared folder can create the same failure as an outdated laminated copy left beside an analyser.
Schedule F Part XIIB sets requirements for the collection, processing, testing, storage and labelling activities that your procedures support.2 During a blood centre licensing inspection, the inspector can therefore move between the floor activity, its procedure and the resulting statutory record. Your document identifiers make that movement easier to follow.
Use staff acknowledgement only as your system defines it
Do not attach a signature sheet to every revision by reflex. First apply the change classification in your approved quality system. A correction to formatting may follow a different route from a change that alters what a technician records or which controlled form they use.
If your document-control or training procedure requires affected staff to acknowledge a revised SOP, the revision record should link to the names, dates and version acknowledged. A signature against an unnumbered SOP title cannot establish whether the person saw Revision 05 or Revision 06.
Acknowledgement also has a limited meaning. It can show that the revised document was received or explained. Where your centre requires training, supervised practice or competency evidence for that change, keep the corresponding record rather than treating attendance as a substitute.
Do not assign the five-year rule automatically
Schedule F Part XIIB Section L names operational records including donor records, master records, issue and component-supply records, cross-matching reports and adverse-reaction records. Its closing note says those listed records must be kept for five years, but an SOP revision-history file is not named in that list.2
Your document-control procedure should set the retention and disposal rule for superseded SOPs and their revision evidence. Keep that decision separate from the statutory periods explained in the Schedule F Part XIIB record list and the broader blood bank record-retention guide.
Test the trail before the assessment
Pick one SOP that changed recently and begin with the copy available to the technician. Follow its identifier through the master list, approval, issue, withdrawal and staff records. A changed version number, missing signature date or unaccounted paper copy shows exactly where the trail breaks.
Software helps when it keeps those references together, but a folder full of PDFs is not document control. When configuring your centre’s compliance records, make the identifier, version and linked approval references required fields. Your centre remains responsible for approving the content, withdrawing stray copies and confirming that staff use the live procedure.