sop for Breakdown of Equipment and Machineries

1.0. OBJECTIVE :

1.1 To lay down a procedure for breakdown of equipments and machineries.

2.0. SCOPE :

2.1 This procedure is applicable to attend the breakdown of all Machines, Equipment used in the Plant.

3.0. RESPONSIBILITY :

3.1 HOD of Dept Informed to EM dept regarding Breakdown
3.2 Maintenance Engineer shall be Responsible for attending and rectifying the Breakdown of Equipment Maintenance.
3.3 Maintenance Engineer informed to QA
3.4 Annual review

4.0. ACCOUNTABILITY :

4.1 Head Engineering department shall be accountable for compliance of SOP.

5.0. PROCEDURE :

5.1 In case of breakdown of equipment/instrument of any department (Dept) chemist/officer of dept shall be stopped the machine and put ‘UNDER MAINTENANCE’ label on it.
5.2 Concern chemist/officer shall be filled the break down memo as per Annex-I in triplicate copies with sign of Dept Head and send it to Engineering and Maintenance (EM) Department.
5.3 After receiving the written breakdown memo (Annex-I), EM head/designee shall be acknowledge receipt of memo by signing on all three copies with date and time of receipt of breakdown memo. Keep first two copies of breakdown memo with EM dept and last copy shall be returned to originating dept.
5.4 EM head/designee shall be assigned the work to the person of EM dept staff as per the nature of breakdown within 4 hours of receiving Annex-I and write the person’s name with time and date in his copy of Annex-I (For Maintenance)
5.5 The Engineering staff should rectify the defect or seek external help for the same by sending a fax / communication to the concerned external agency.
5.6 If rectification / servicing shall be done by an external agency, the concerned engineer should check and certify that the job has been done properly.
5.7 While rectification / servicing of faulty equipment if any deviation is found, which is not within range of acceptance criteria, the concerned engineer should rectify it.

5.8 If any deviation noted during breakdown of equipment concerned person shall be intimated to Quality Assurance department.
5.9 The QA department should classify the breakdown as non-critical and critical as given below:
5.9.1. NON CRITICAL BREAKDOWN:
The breakdown which has caused the deviation with standard operating condition, but do not have a potential for impact on the identity, strength, quality and purity of a product. Such breakdown does not require annual review and evaluation.
5.9.2. CRITICAL BREAKDOWN:
The breakdown which has caused the deviation with standard operating condition and have a potential for impact on the identity, strength, quality and purity of a product. Such breakdown should be intimated immediately to the user department and the QA department on Intimation Note. Record of such breakdown and the corrective action with supporting documents (if any) shall be properly documented and recorded in History Card
5.9.3. MOST CRITICAL BREAKDOWN:
The breakdown, which has caused the deviation with standard operating condition of the critical equipment/utilities/system and has a potential for impact on the identity, strength, quality and purity of a product. Such breakdown and corrective action taken, requires Change Control procedure. Such breakdown and its corrective action should be intimated immediately to the user department and the QA department, which should be followed by the Change Control procedure. Record of such breakdown and its corrective action with supporting documents should be properly documented and recorded in History Card.

5.10 Based on the above review the QA department shall be gave their recommendation, which may include corrective action considering the cGMP (Current Good Manufacturing Practices) and steps to avoid such incidence/deviation in future.
5.11 The concerned department head/supervisor shall certify the correct working of equipment after rectification/servicing on break down memo.
5.12 EM engineer shall fill up the ‘breakdown history card’ in detail describing the nature of fault and its corrective action, in Break Down History card Annex-II.
5.13 Engineering department should review such equipment history for repeated nature of breakdown and should make necessary changes in preventive maintenance plan or necessary modifications in equipment, by taking the manufacturer’s assistance and an approval from the QA and the concerned department.

6.0. ABBREVIATION :