ISO 13485 · Medium · 12 min lesson
Compiling the batch record - line clearance, in-process checks, deviations, nonconforming product, release and electronic records
ISO 13485:2016 clauses 4.1.6, 4.2.5, 7.5.1, 7.5.5, 7.6, 8.2.6 and 8.3; 21 CFR 820.45 and 820.35 (QMSR); 21 CFR 11.10
What you will learn
- Compile a batch record that shows line clearance, material issue, in-process checks and actual process values, corrected correctly.
- Handle deviations and nonconforming product through clause 8.3, with rework, concession and segregation recorded in the batch.
- Reconcile the batch, make a documented release decision under clause 8.2.6 and control electronic records under clauses 4.1.6 and 4.2.5.
Key takeaways
- The batch record is a controlled form filled in at the time of work, with corrections made by single line, initials, date and reason (clause 4.2.5).
- Line clearance is signed before production starts to prevent mix-ups of labeling and components (clause 7.5.1; section 820.45).
- In-process records show the limit, actual value, calibrated instrument and person; validated process parameters are recorded against their range (clauses 7.5.1, 7.5.6, 7.6).
- Deviations and nonconforming product are recorded, segregated and dispositioned under clause 8.3 with the authoriser named.
- Reconcile the batch, then release under clause 8.2.6 by an identified, independent person; electronic records need clause 4.1.6 validation and 21 CFR 11.10 controls where applicable.
Free practice question
The packing record of lot 2431 shows line clearance signed at 11:30. The first carton is dated 09:10 on the same record. The supervisor says the line was clean anyway.
How should an auditor assess this?
The control against mix-ups was not shown, because clearance after start cannot prevent a mix-up.
Correct. Section 820.45 and clause 7.5.1 require labeling operations that prevent mix-ups, so clearance must precede production.
Acceptable because the supervisor says the line was clean.
Not quite. A verbal assurance is not a record, and clause 4.2.5 requires documented evidence at the time.
Acceptable if the lot passed final inspection.
Not quite. Final inspection does not replace a preventive clearance control required by clause 7.5.1.
Only a spelling issue in the time field.
Not quite. The sequence of times shows the control was out of order, which is a substantive gap under clause 7.5.1.
Key terms
- line clearance: The check and signature that a line is free of materials and labeling of the previous lot before a new one starts.
- deviation: Any departure from approved instructions or limits, recorded and assessed for effect on the product.
- nonconforming product: Product that does not meet its requirements, identified and controlled under clause 8.3.
- concession: Authorised use or release of nonconforming product with justification and approval (clause 8.3.2).
- rework: Action on nonconforming product to make it meet requirements, done under procedure and re-verified (clause 8.3.4).
- reconciliation: Proof that started units equal passed, rejected, sampled and lost units, and labels issued equal used, destroyed and returned.
- audit trail: A secure, time stamped log of who created, changed or deleted an electronic record (21 CFR 11.10(e)).
- ALCOA: Data integrity principles: attributable, legible, contemporaneous, original, accurate.
Official sources
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
- 21 CFR 820.10 and 820.7, Quality Management System Regulation requirements and incorporation of ISO 13485 (eCFR)
- 21 CFR 820.35, Control of records (eCFR)
- 21 CFR 820.45, Device labeling and packaging controls (eCFR)
- 21 CFR 820.184, Device history record (former text, Cornell LII)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.