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APPENDIX C

Follow-Up Procedure

Purpose

The objective of this procedure is to ensure the closure of all NCs appeared in the QA audit according to the agreed upon corrective actions or escalating the non-closed NCs to the senior management to take the required and suitable action.

Definitions

·         None

Entry Criteria (AND)

No

Criteria

Exit Criteria Of

1

Corrective Actions Approval

Ritsol_QA_Execution_Procedure

2

Audit Report Approval

Ritsol_QA_Execution_Procedure

Inputs

No

Input

Coming from/Output Of

1

Approved Corrective Actions

Ritsol_QA_Execution_Procedure

2

Approved Audit Report

Ritsol_QA_Execution_Procedure

Activities

No

Activity

Responsible

Input

Output

Temp/Form

1

Implement the approved corrective action.

Author / Process Owner

Approved Corrective Actions

Implemented Corrective Action

 

2

Release new or revised work product.

Author / Process Owner

Implemented Corrective Action

Corrected Work Product

 

3

Communicate the corrective action and its impact to the relevant stakeholders.

Author / Process Owner

Corrected Work Product

Communicate Corrective Action

 

4

Inform QAR about the readiness to verify the implementation of the corrective actions.

Author / Process Owner

Corrected Work Product

Readiness Notification E-Mail

 

5

Track the planned closure dates for all corrective actions and follow-up for unresolved NCs.

QAR

Approved Audit Report

Identified NCs to be tracked

 

6

Schedule follow-up audit after the implementation of the corrective actions.

QAR

Identified NCs to be tracked

Scheduled Follow-up Audits

 

7

Audit on the corrective actions implementation.

Corrected Work Product

Scheduled Follow-up Audits

Identified Closed and Opened NCs

 

8

Escalate unresolved issues according to the pre-defined escalation mechanism.

QAR

Identified Opened NCs

Escalation Reports

 

9

Conduct peer review as per the peer review process and plan.

PR

As per the process

As per the process

As per the process

10

Conduct QA audit as per QA process and plan.

QAR

As per the process

As per the process

As per the process

11

Conduct CM activities as per the CM process and plan.

CC

As per the process

As per the process

As per the process

12

Collect measurements as per the measurement plan.

MC

As per the process

As per the process

As per the process

13

Monitor the progress as per the PM process and plan.

PM

As per the process

As per the process

As per the process

14

Approve the outputs of the procedure

SM

Closed NCs  

Approved Closed NCs

 

Outputs

No

Output

Going To/Input Of

1

Approved Closed NCs

Ritsol_PM_Monitoring_and_Control_Procedure

Ritsol_CM_Functional_Configuration_Audit_Procedure or the calling procedure that has a need for instant audit.

Exit Criteria (AND)

No

Criteria

Entry Criteria Of

1

Closed NCs Approval

Ritsol_PM_Monitoring_and_Control_Procedure or the calling procedure that has a need for instant audit

Metrics

These measures can be useful to support the process enactment, or future enactments.

·         Actual versus planned time and effort

·         Actual percentage of closed NCs.

·         Actual percentage of escalated NCs.

Subjects for Review

·         None

Configurable Items

·         None

 

 

 

 

Quality Management System (QMS)