Breakdown Handling procedure in Pharma company

Why is it important to record breakdown ?

* The breakdown record is used as input into the Breakdown Analysis (BDA).

* This information can also be used to identify topics for training in which section more mistakes are occurred.

* Allows the team to get to the root cause(s) to reduce to zero breakdowns.

* Allows to figure out if the cause(s) of the problem has a relation with the Man Method, Machine or materials so all contributing factors can be identified and appropriate countermeasures applied.

* Allows over time to evaluate the effectiveness of maintenance activities and help determine if we need to modify our current preventive plan.

Breakdown Handling procedure 

Follow the process flow for the area where problem was seen on the line – (Breakdown Record). Identify how each step functions and what purpose does it do. Identify what conditions must be in place for each step to function properly, e.g. Temperature, speed, pressure, adjustment, etc. Agree as a team, when in doubt, go out to shop floor and confirm. When the breakdown occurs, the user department initiates the breakdown memo & fills up details as shown below:

Department:

Date & Time:

Equipment / Utility Name:

Area Name: 

Product Name:

Batch No.:

Details of breakdown:

Initial Impact Analysis:

Initial Risk Analysis:

Carry out Breakdown problem analysis using 5W 1H method.

What – What specific thing (e.g. product / part) are you seeing the problem on?

When – When have you seen the problem? (Start-up, Ramp Down, normal production, after a changeover, shift, time etc).

Where – Where are you seeing the problem? (e.g. packing line, equipment, specific location, material or activity)

Who – Who reported the problem? (e.g. New operator, skill dependent or independent)

Why – Why is this considered as problem e.g. increasing frequency, look at historical data to determine if pattern exists

How – How does the problem differ from normal operation or ideal state

After completing the 5W-1H details, this information is used to construct a phenomenon statement – The specific problem to be solved. 

After filling all the details, User shall hand over the memo to QA department. QA department shall evaluate and categorize the Breakdown in Critical /  Non Critical. 

After that, Engineering Department will receive the memo and write up the evaluation details of what might be the issue in short description. Engineering will start Maintenance activity.

After successfully maintenance activity, Engineering department will record the root canuse and action taken. Then engineering department will handover Memo to User department. User department will check the activities carried out and then user shall provide comment. User shall conduct final impact Analysis & Final risk assessment.

User department shall then handover the memo to QA department for final closing.

Most of the Pharma organizations use ERP software nowadays. In such a case, Breakdown situations follow below workflow: 

User department detects an equipment issue and then alerts Engineering by creating Breakdown notification. 

Relevant Engineer creates and assigns a work order for asset inspection. 

The assigned technician analyses the problem and provides feedback on the expected time, parts, and costs associated with repair or replacement. If the equipment malfunction being evaluated cannot be resolved, this may lead to a significant waste of resources. 

If possible, the assigned maintenance technician fixes the issue.

The Operator restarts the machine to verify the correct performance. 

After maintenance is complete, the maintenance team may use the newly acquired information to track and prevent similar failures in the future as part of a preventive maintenance program. Additional parts or devices may be ordered and stocked to reduce the length of any future equipment downtime.