Blood Bank Quality Manual: SOP Control for NABH

For NABH, your blood bank quality manual and SOP-control records should let a technician and an assessor establish six facts: which procedure is current, who owns it, who approved it, when it became effective, what happened to the previous version and which version governed the work being examined. NABH’s current Blood Centre standards place the quality manual, procedures and records inside a controlled quality management system, so an approved document by itself is only part of the evidence. ¹

Schedule F Part XIIB sets the operational and record-keeping scope for a licensed blood centre, including personnel, equipment, collection, processing, testing, storage, labelling and specified records. Your document-control system should connect those activities to approved procedures without replacing the operational records themselves. ²

The document-control trail an assessor can follow

Start with the trail, not the size of the manual. For any selected activity, your centre should be able to move from the quality manual to the applicable SOP, then to its approval and revision history, and finally to evidence showing who performed the work under that version. ¹

When your team maps NABH and NBTC requirements, assign each applicable requirement to the policy, SOP, form or register that demonstrates it. A requirement with no document owner becomes an audit scramble when two departments assume the other one maintains the evidence.

What the quality manual should say

Your quality manual should explain how control works across the centre. Keep task-level instructions in SOPs so that revising one process does not require rewriting several pages of the manual.

Make the manual answer these questions:

• Who may prepare, review, approve, issue and withdraw a document?
• How are policies, SOPs, forms, worksheets and external documents identified?
• Where is the master list kept, and who may change its status?
• How does a draft become approved and effective?
• What starts a review, and how is a no-change review recorded?
• How are linked forms, training material and software configurations assessed during a revision?
• How are obsolete copies removed from work areas and retained in the archive?
• How are deviations, corrections and other quality records connected to the governing procedure?

Separate document review from revision. A review may conclude that no change is needed, but it should still leave the reviewer, date and decision in the control record. A revision changes controlled content and therefore needs a new version, approval, issue and withdrawal trail.

Control each SOP and the master list

Use a consistent header or control page for every SOP. It should carry the document title, unique identifier, process owner, version or revision, issue date, effective date, page numbering, preparer, reviewer, approver and the document it supersedes.

List linked forms, worksheets and templates as well. If a form changes independently, the master list should show which revision remains compatible with the SOP.

Make the master list decisive

Your master list should be the quickest way to settle a version dispute. Record the document identifier, title, owner, current revision, approval date, effective date, review status, point-of-use location and whether the document is draft, current or obsolete.

Keep drafts away from routine work. For paper copies, assign controlled-copy numbers or named locations and record their replacement. For electronic documents, restrict publishing rights and prevent an unapproved draft from appearing beside the current procedure.

An approval must identify a person with the assigned authority. A typed name pasted into a document does not provide the same trail as a dated signature or an electronic approval tied to an individual account.

Record review, revision and withdrawal as one path

Use one recorded path for every change: log the reason and owner, review the effect on linked forms and staff, obtain approval, set the effective date, issue the current version and withdraw the superseded copy. After issue, your work records should allow the centre to identify the version that applied on the activity date. NABH’s document-control requirements cover approval, issue, change control and protection against unintended use of obsolete documents. ¹

Keep the revision history specific. “Updated as required” tells the next reviewer nothing; “replaced Form QF-12 revision 2 with revision 3 and added supervisor verification” identifies what must be checked.

Withdrawal needs evidence from every point of use. If the server carries revision 6 but a laminated revision 4 remains beside the workstation, the master list has not controlled the work area. Record the location checked, the copy removed and the person who completed the withdrawal.

Connect staff activity to the correct version

A training signature shows that somebody attended or acknowledged a document. The stronger trail combines the effective date, staff acknowledgement or training, individual authorisation where applicable, and an operational record carrying the activity date and operator identity. NABH’s quality system requirements connect controlled procedures with personnel and quality records. ¹

Suppose revision 6 became effective on 1 August and an assessor selects a worksheet dated 25 July. Showing revision 6 would be the wrong answer for that transaction. Retrieve revision 5 from the obsolete archive, show that it was effective on 25 July and connect the worksheet or electronic record to the technician who performed the work.

Now select an activity after 1 August. Show when revision 6 was issued, when affected staff were briefed or assessed, and how the form revision or electronic workflow maps to that SOP. You do not have to make staff handwrite an SOP number on every entry if your controlled form or system release already provides a reliable version map.

Run this test against both TTI testing records and component separation records. Different departments often expose different gaps: one may retain the historical SOP but lose the old worksheet, while another may retain the work record without preserving the applicable procedure.

Schedule F Part XIIB names records including donor records, master records for blood and components, the issue register, component supply records, crossmatching reports and transfusion adverse reaction records. Its closing note requires the listed records to be kept for five years. ² When setting your document archive policy, make sure historical SOPs remain available long enough to interpret the operational records covered by your record-retention system.

Control external documents, forms and screens

Your external-document register should include the current NABH standard, the applicable Drugs and Cosmetics Rules and any other instrument your centre relies on. Record the title, issuing body, edition or revision, owner, review date, applicable processes and the internal documents assessed when the source changes. NABH document control extends to applicable external documents used within the quality system. ¹

A source update should create an impact record even when no SOP change follows. The record can state that the owner reviewed the update, identified the affected procedures and concluded either that revisions were required or that existing controls remained adequate.

Control blank forms as documents and completed forms as records. The blank form needs an identifier and revision; the completed form needs protection, retrieval and retention. Where staff work through software screens, maintain a mapping between the approved procedure, the relevant configuration or release and the record produced. ¹

Run a retrieval test before the assessment

Ask a technician to perform this check without help from the person who maintains the quality manual:

1. Open the current SOP for a routine assigned activity.
2. Match its identifier, revision and effective date with the master list.
3. Show the preparer, reviewer and authorised approver.
4. Locate the previous version and its revision history.
5. Show how obsolete copies were withdrawn from each point of use.
6. Select one work record before the revision and one after it.
7. Connect each record to the applicable SOP version and staff member.
8. Retrieve the relevant training, acknowledgement or authorisation evidence.

Carry any failed retrieval into your broader NABH audit preparation. “The quality manager knows where it is” remains a gap if the technician at the point of use cannot identify the current procedure.

Paper and software fail in different places

A paper master list fails when controlled copies move without a withdrawal entry. A digital repository fails when staff keep downloaded files after a revision. Include both risks in your manual-versus-digital control review.

Whether your centre uses RAKT or another system, ask for a live demonstration rather than a feature list: retrieve the current procedure, show its approval trail, recover the historical version and connect a dated operational record to the person who performed the work. Apply the same test when evaluating a digital compliance setup.

If a technician can open the current SOP but cannot show who approved it, the trail stops. If the quality manager can show every revision but cannot connect a selected work record to the version in force, the trail also stops. Your system is ready for assessment when both routes can be demonstrated from the records your centre actually uses.

Sources

1. NABH Accreditation Standards for Blood Centres, current edition nabh.co
2. Drugs and Cosmetics Rules, 1945, Schedule F Part XIIB cdsco.gov.in