Presented By- Manoj V.Kumbhar

Preventive Maintenance and Calibration

Defination.

Types of Maintenance.

Why we perform the Preventive maintenance activity.

Typical responsibilities of engineering. (maintenance)

Advantages.

Contents-

Our practice.

Calibration.

Our practice and reasons to perform the calibration.

Regulatory awareness.

“Actions necessary for retaining or restoring a piece of equipment, machine, or system to the specified operable condition to achieve its maximum useful life."

Definition-

Preventive Maintenance

Predictive Maintenance.

Breakdown Maintenance.

Types of Maintenance

It is a care and servicing by personnel for the purpose of maintaining equipment in satisfactory operating condition by providing for systematic inspection, detection, and correction.

Preventive Maintenance

Or in the another words…. Preventative maintenance is performed while the equipment is still working, so that it does not break down unexpectedly.

Or

It is also known as “Periodic maintenance”.

Time based maintenance consists of periodically inspecting, servicing and cleaning equipment and replacing parts to prevent sudden failure and process problems.

Periodic maintenance ( Time based maintenance - TBM)

It is the techniques, are designed to

help determine the condition of in-

service equipment in order to predict

when maintenance should be performed.

Predictive Maintenance.

Repairs or replacements performed after a machine has failed to return to its functional state following a malfunction or shutdown.

Breakdown Maintenance.

What it includes….Repairs, replacements of spares or even overhaul to ensure the machine is put back in operating condition.But…… in small factories where down times are non-critical and repair cost are less than other type of maintenance.

Since we have the adverse effect of the same.So Our aim is…..

1.To avoid breakdown time of equipment.

2.To avoid delay in process time.

3.To keep equipment in healthy condition.

4.To avoid the spares cost as compare to

breakdown of machine.

5.It is an schedule based and it’s a cGMP

Practice.

Why we perform the PM-

Assure optimization of the Maintenance Organization structure.

Analysis of repetitive equipment failures.

Estimation of maintenance costs and evaluation of alternatives.

Forecasting of spare parts.

Typical responsibilities of engineering. (maintenance)

Assessing required skills required for maintenance personnel.

Ensures that equipment is performing effectively and efficiently.

To be cont…

1. Enhances the efficiency of equipment

keeping them running more efficiently

also impact on less electrical power

expenses.

2. Enhances the performance of

equipment's by increasing uptime.

Advantages of PM.

3. Extends the useful lifecycle of equipment's decreasing the need for capital replacements(i.e.-Spares inventory).

4. Saves the cost.5. It saves productive time of the

equipment/ process.

Cont…

6.It saves labor intensive and time.7.Reduces cost of replacement. 8. Improved system reliability.

Cont..

We follow the Standard Operating Procedure.

Preparation of Annual Preventive maintenance Planner.

Clearance from User department to carried out the PM activity.

Execution of PM activity and completion of documentation.

Our Practice….

What is Calibration?

Calibration is a comparison between a known measurement (the standard) and the measurement using your instrument.

Calibration

SOP to be refer to carried out the activity. Instruments are categorized as critical and

non-critical. For critical instruments the frequency is six

months and for non-critical instruments it is once in year.

Annual Planner for calibration to be prepare.

Our Practice to perform the Calibration.

A new instrument. After an instrument has been repaired or

modified. When a specified time period has elapsed. When a specified usage (operating hours)

has elapsed.

Calibration may be required called for the following reasons:

ICH Q7 guidelines- Schedules and procedures should be

established for the preventive maintenance of equipment.

Regulatory awareness.

As per cGMP requirements, schedules of preventive maintenance for each equipment in the facility should be prepared, monitored and documented.

21 CFR part 211 of USFDA- 211.67 on equipment cleaning and

maintenance.

Cont..

Frequency of the activity should be based on criticality w.r.t its impact on the quality of the product.

Cont..

Preparation and review of PM schedule-

Engineering.

Approval of PM schedule- QA

Execution of PM schedule- Engineering.

Ensuring availability of equipment for PM-

Concerned owner of equipment.

Responsibilities.

Any Question?

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