SOPs

Breakdown Maintenance: This SOP [Breakdown Maintenance] will make as per SOP for SOP of the respective company/Organization. Font/line spacing/Margin/Page set up/Header/Footer etc. will change as per requirement of SOP for SOP.

1.Purpose

The purpose of this SOP is to define the procedures involved in conducting and handling breakdown maintenance activities of the equipments/machines of XX Pharmaceuticals Limited.

2.Scope

This Standard Operating Procedure applies to all equipments/ machines of GMP all area of XX Pharmaceuticals Ltd.

3.Definitions / Abbreviation:

• BM: Breakdown Maintenance
• SOP: Standard Operating Procedure
• QA: Quality Assurance

4. Responsibilities

The responsibilities are as follows:

Initiating Department:

• To inform Quality Assurance, Head of Plant Operations and Engineering Department for the breakdown maintenance of linked equipments, machines or utility rest area.
• To fill up the breakdown maintenance memo and backup the carbonated copy.
• To put the status label “UNDER MAINTENANCE” on the machine.
• To check related machines, equipments or utility services along with Quality Assurance personnel after completion of BM Activities.

Engineering Department/Maintenance Department

• To receive the BM Memo and arrange for be present the breakdown maintenance.
• To assess the cause of breakdown and resolve the problems.
• To oversee the BM job and update necessary record.
• To fill up the BM History form for each machine after completion of Breakdown Maintenance.
• To preserve the BM related documents.

Technician

• To execute the breakdown maintenance by following the appropriate safety precautions

Quality Assurance

• To evaluate and select disposition or further operation of products/batches under bearing
• To inform Validation Department [Engineering End] to perform requalification or recalibration of the machine/equipment if it is required.
• To certify that actionable and recommendation are closed.

Validation Department (at Engineering End)

• To perform requalification or recalibration of the equipment/machine if it is necessary.
• To issue the Breakdown Maintenance Memo for the individual sections.

Head of Engineering

• To monitor actions of engineering personnel who perform the Breakdown Maintenance activities and to provide technical provision and assistance with documentation supplies.
• To assessment the history files of equipment’s maintenance annually and at the time of incidence of major failures and to identify the repeated component of failures or other events.
• To confirm that the equipment maintenance history files are secured in the Engineering Department.

Head of Quality Assurance

• To confirm overall implementation of this SOP

5.Revision Details

• Sl. No./ Version No./ Effective Date/ Change History to be add here

6. Procedure

Precautions: All maintenance work must be accomplished safely in agreement with the requirements of the Plant Safety Declaration and the safety notices around the plant. Specific consideration must be paid to the following-

Personal Protective Equipment [PPE] and clothing appropriate to the job must be worn.

Equipment must be electrically inaccessible and locked out where potential.

“Under Maintenance” status label must be attached on the machine during BM activities.

“Shifting in Progress for Maintenance Work” status label must be attached on the machine at the time of shifting for maintenance activities.

6.1 Concerned Department

6.1.1 In case of equipment, machine or utility breakdown, the related departmental personnel will label it with ‘UNDER MAINTENANCE’ status label.

6.1.2 The BM Memo will be a pre-printed, bi-layer, self-carbonated paper which will be filled up by the related departmental personnel and the original copy will be sent to the Engineering Department to evaluate and be present at the problem. The carbonated copy will be store by the relevant department.

6.1.3 The pre-printed serial no. of each page of “BM Memo” will be considered as the “BM Memo” number.

6.2 Quality Assurance Department

6.2.1 Quality Assurance personnel would estimate the breakdown to assess the influence on product quality, safety, efficacy matters and take decision whether the product would be disposed.

6.2.2 Quality Assurance will inform the Validation Team [at Engineering End] after completion of breakdown maintenance to execute the requalification or recalibration of that machine if it is necessary.

6.2.3 Quality Assurance may hold the production batches if any harmful impact occurs till further study.

6.3 Engineering Department

7.3.1 Engineering personnel will receive the “BM Memo” and evaluate the reason and resolve the problems.

6.3.2   Before initiating the maintenance activities, detach unwanted services [‘LOTO Procedure’ to be followed] from the safety point of view.

The breakdown maintenance activities will be carried out according to the equipment handbook (if required) under the supervision of maintenance supervisor/Line In-charge.

6.3.3 A tag “Shifting In Progress For Maintenance” will be put on the machine during shifting to the workshop for maintenance Activities.

6.3.4 After completion of BM activities, relink the utility services and take the usage trial in presence of relevant departmental personnel and Quality Assurance personnel. After successful trial, engineering department will deliver the machine to the relevant department.

6.3.5 Engineering department shall assess the need for requalification or recalibration in discussion with Quality Assurance and document the identical in the memo. Quality Assurance in turn shall inform to production and validation team[at Engineering End] for recalibration or requalification.

6.3.6   Preventive maintenance calendar can be changed based on the rate of breakdown of a specific machine.

6.3.7 Engineering department will maintain the data record of the breakdown activities with trend analysis.

6.3.8 After finishing the breakdown maintenance activities engineering/maintenance person will fill up the “Breakdown Maintenance History Form” of that “Machine/Equipment/System” and store all breakdown related documents in Engineering Department.

6.3.9 If the Area is out of any possible harm and found okay, routine operation will be started after Quality Assurance Inspection with adequate cleaning.

6.3.10 Photocopy of all approved forms will be used. Computer generated copies of all related form can be used with proper note, mentioning in the footer-

‘’This is the computer generated form and similar in that of original form”

8. Annexure [Downloadable File Available]

Annexure-I:   Breakdown Maintenance Memo.

Annexure-II: Breakdown Maintenance History form.

This all about the SOP for “Breakdown Maintenance”. This is the basic process and may be change based on company policy [but not limited to].