Top 10 Non-Conformities Found During NABL Audits (and How to Avoid Them)

Getting NABL accreditation is not just about documentation - it’s about building a robust, consistent quality system that works every day. During assessments, NABL assessors often find certain Non-Conformities (NCs) that can delay certification.

Here are the Top 10 Common NCs raised during NABL audits (as per the new ISO 15189:2022 standard) - and how you can avoid them.

 

1. Lab Director’s Job Description (JD) Missing Risk Management Responsibility

Issue:
Many labs fail to mention “Risk Management” as part of the Laboratory Director’s role.
Why it matters:
According to the new standard, the Lab Director must oversee risk identification, evaluation, and control measures across all processes.
How to avoid:

• Update the Director’s JD to clearly include “Responsible for identification, evaluation, and control of laboratory risks.”
• Maintain documented evidence of risk reviews led or approved by the Director.

 

2. Improper Competency Assessment & Missing Raw Data

Issue:
Competency assessments are either not done correctly or lack supporting raw data.
Why it matters:
Assessors look for objective evidence - practical evaluation, test performance data, or observation records.
How to avoid:

• Use structured formats for competency evaluation (e.g., direct observation, blind sample testing).
• Maintain raw data sheets and evaluation reports for every staff member annually.

 

3. Incomplete Risk Assessment Coverage

Issue:
Risk assessments often miss covering all aspects of lab operations - such as pre-analytical, analytical, and post-analytical phases.
How to avoid:

• Create a risk matrix covering each lab function: sample handling, equipment, reagents, environment, staff safety, etc.
• Review and update it at least annually or after any incident/change in process.

 

4. Staff Not Aware of QC (Quality Control) Process

Issue:
Staff members fail to explain QC procedures during the audit.
Why it matters:
This indicates poor training and weak implementation of quality culture.
How to avoid:

• Conduct regular QC awareness sessions and short internal quizzes.
• Ensure every staff member knows:
• What QC is performed,
• How to interpret control results, and
• Actions to take when controls fail.

 

5. Critical Alerts Not Updated or Communicated

Issue:
Critical alert lists exist but are not updated with current result values or communicated properly.
How to avoid:

• Review and update the Critical Alert List quarterly or whenever test ranges change.
• Document communication protocols - who to inform, how, and within what timeline.
• Keep signed acknowledgment from staff to confirm awareness.

 

6. Inventory Management Not Implemented Properly

Issue:
The process for inventory management is well-documented but not followed in practice - records are incomplete or outdated.
How to avoid:

• Maintain real-time inventory logs (digital or manual).
• Record stock issue, expiry checks, and daily usage.
• Cross-check physical stock vs. records monthly.

 

7. Inconsistent SOP for Glucose Tolerance Tests (GTT/GCT)

Issue:
Mismatch between SOP and practice - for example, SOP mentions 82.5g glucose, but lab uses 75g as per guidelines.
How to avoid:

• Review and update SOPs to match actual practices and latest guidelines.
• Train authorized signatories on indications for GCT, GTT, and glucose load procedures (50g, 75g, 100g).
• Keep reference literature attached with the SOP for clarity.

 

8. Incomplete Organogram and Communication Flow

Issue:
Organogram doesn’t clearly define authority, reporting hierarchy, or interrelationship among staff.
How to avoid:

• Prepare a clear Organizational Chart showing:
• Roles and responsibilities
• Reporting lines
• Quality and technical supervision
• Display it visibly in the lab and attach it in the Quality Manual.

 

9. Quality Indicators Not Supported by Raw Data

Issue:
Quality indicators are being monitored, but the numerator and denominator data (raw counts) are missing or inconsistent.
How to avoid:

• Maintain a simple spreadsheet or logbook to record both raw data and calculated percentages.
• For example: TAT = (Samples reported within defined time / Total samples received) × 100
• Review data monthly during internal audits or MRMs.

 

10. Quality Objectives Are Not Measurable

Issue:
Labs often list generic objectives like “Improve Quality” or “Reduce Errors” - which cannot be measured.
How to avoid:

• Define SMART objectives:
• Specific, Measurable, Achievable, Relevant, Time-bound.
• Example: “Reduce TAT Outliers from 12% to below 5% in next 6 months.”
• Monitor progress during every Management Review Meeting.

 

Final Thoughts

Most Non-Conformities arise not from negligence, but from lack of awareness or incomplete implementation. The key to avoiding them lies in regular internal audits, staff training, and clear documentation.

At Qualityveda, we help labs identify and close these NCs well before assessment. From gap analysis to final certification, our Quality Specialist Program ensures your lab stays compliant, confident, and NABL-ready at all times.