Incident/ Deviation/ Investigation

Why deviation management is performed 

— to find and fix problems.

Effectively managing deviations in pharmaceutical industry is crucial to ensuring product quality, regulatory compliance and patient safety.

Deviation is departure from approved procedure due to unexpected situations, like- breakdown of the equipment/ facility or any other reasons 

Examples of deviations are-

Equipment failure 

Procedure departure 

Human failure 

Material, process and system related failure 

Deviation can be categorised on basis of severity of impact -

1. Low severity _ Minor deviation- Having no direct or indirect impact on product quality and patient safety 

2. Medium severity _ Major deviation - May have indirect impact on product quality and patient safety 

3. High severity _ Critical deviation - May have direct impact to the product quality and patient safety 

DMAIC approach being followed to handling of deviation

Investigate the deviation following DMAIC approach, identify the root cause following different techniques (Fish bone diagram and Why Why analysis) and initiate corrective and preventive measures.

Basic tools such as 5-Whys,

PEMME (personnel, equipment,

method, materials, environment), and

fishbone diagrams.

Description of deviation contains identification initial assessment -

1. What happened

2. Where happened

3. When happened

4. Who observed

5. Assessment of deviation and its impact

Cancelling and Reopening of Deviations: Cancellation of open deviation records usually is allowed if there are duplicates, but such instances should be documented. It is important to explain why multiple records were generated for the same event or if a raised deviation does not qualify as such. Additionally, it is generally permissible to reopen a closed deviation for minor corrections, clarifications, or additions, but modifications or additions must adhere to the original intent of the investigation or root-cause analysis. Unless they are self-evident, rationale behind changes should be documented.

The following Methodology techniques may be employed as necessary to facilitate the determination of the root cause-
A. 5 Why analysis
B. Cause and Effect analysis - Ishikawa or ‘fishbone’ diagram

C. Brainstorming

D. FMEA or process flow chart
E. Fault Tree Analysis
F. Any other suitable tool(s)

All minor/major/critical deviations shall be investigated thoroughly with chronology of events to identify the root cause, defining corrective and preventive actions & assess the impact to product quality.

cross functional team shall be formed for investigation, which is headed by the QA.

Root cause shall be identified by different tools like 5 Why analysis, cause and effect diagram, brainstorming etc.

5 why shall be used for investigation of human error and probable root cause/ contributing factors shall be identified by the cause and effect diagram and brainstorming.

once probable root cause/ contributing factor is identified, further investigation shall be performed through other technique to identify the root cause.

DMAIC (Define, measure, analyse, Improve and control) approach shall be used to perform the investigation.

Define- Description of deviation

Measure- Review of historical data

Analyse- Summary of investigation and identified root cause

Improve and control- Propose corrective and preventive action

Define_