Handling of Regulatory Audits

1.0 OBJECTIVE 

1.1 To adopt a procedure to ensure that the inspection process goes smoothly. 

2.0 SCOPE 

2.1 This procedure is applicable for all regulatory inspections carried out at company Name. 

3.0 RESPONSIBILITY  

3.1 Front Room Coordinator/Moderator  

He is the first in contact with the inspectors and will be responsible for answering all the queries asked by the inspector. 

3.2 Inspection observer (Scriber)

To take notes of the documents requested and pass on to the runner  

3.3 Back Room Coordinator

To ensure the quick and efficient retrieval and review of documents and the flow of documents and people to the inspection room

3.4 Back Room assistant

To assist the back room coordinator    

3.5 Runner

To ensure that the documents requested are arranged from the backroom   

4.0 ACCOUNTABILITY         

4.1 Head - Quality Assurance

5.0 PROCEDURE     

5.1  Front Room/inspection room: the room where the inspectors will be seated

5.2 Back Room: The room where all the documents will be arranged as requested by the inspectors.

5.2.1 Security will inform HRD as soon as any regulatory inspectors arrives at the factory

5.2.2 In case if prior information is there about the arrival of the inspectors, HRD will be available at the security.

5.2.3 The inspectors reaching the factory will be provided with the ID card at the entry by security after duly entering the inspectors name in the register.

5.2.4 Security or HRD will accompany the inspectors to the Reception or to the Helmut block entrance 

5.2.5 QA Head or his designee shall receive them at the entrance of the Helmut block and take them to Conference Room.

5.3 Introduction of Key Staff members 

5.3.1 Auditors/Inspectors will be introduced to the Key staff

5.3.2 Auditors/Inspectors will be briefed about the Company through power point presentation.

5.3.3 If any agenda is already finalized the same shall be followed or will be requested for an agenda. 

5.4 Company tour 

5.4.1 If required or if mentioned in the agenda, the inspectors shall be taken for company tour.

5.4.2 During the tour only minimum number of people will accompany the inspectors.

5.4.3 QA head will be available with the inspectors for answering any queries asked by inspectors.

5.4.4 Departments heads will join the inspection team when the inspectors enter there department. If required the help of the department head shall be taken to answer any specific queries requested by the inspectors.

5.5 Documentation review 

5.5.1 All the documents requested by the inspector’s will be noted down by the inspection observer and passed onto the backroom.

5.5.2 Each individual request asked by the inspector shall be written down by the inspection observer. The details shall be as follows,

·  Detailing date

·  Time

·  Inspector’s name

· Subject and the requested information 

5.5.3 The notes/requested documents will be passed to the backroom through runner for arrangements of the documents.

5.5.4 The backroom coordinator with the help of his assistant shall prepare all the documents requested.

5.5.5 The backroom coordinator will ensure the quick and efficient retrieval and review of the documents requested.

5.5.6 He shall also ensure the flow of the documents and people to the inspection/front room.

5.5.7 The documents requested shall be presented to the inspector by the Front room coordinator / Moderator.

5.5.8 If any document(s) or part of the document(s) is requested by the inspector for photocopying the same shall be arranged by the backroom coordinator.

5.5.9 The photocopies shall be taken in duplicate and both the copies will be stamped as uncontrolled copy, signed and dated by documentation controller and entered in the register.

5.5.10 One copy of the photocopied document shall be sent to the front room through runner and handed over to front room coordinator/moderator.

5.5.11 All the documents sent to the front room shall be original documents (with original signature) and all the SOPs, Specifications and test procedures  shall be the controlled copies. 

5.6 Exit meeting

5.6.1 The exit meeting will be attended by the inspection coordinator, plant/site Manager, Key management personnel including QA and QC management.

5.6.2 During exit meeting only the inspection coordinator or the highest hierarchy present shall speak to clarify any misunderstandings or misinterpretations about the presented facts. 

6.0  ANNEXURES:         Nil 

7.0  CHANGE HISTORY