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APPENDIX C

Execution Procedure

Purpose

The objective of this procedure is to execute the QA auditing activities on the project level according to the QA plan. Auditing and evaluating project processes and work products are done to ensure the adherence to applicable process description, standards and procedures as per the project’s processes. Auditing ensures that all issues and/or deviations detected during audit process are communicated to relevant stakeholders and that the corrective actions are identified and documented.

Definitions

·         None

Entry Criteria ((1 AND 2 AND 3) OR (2 AND 4))

No

Criteria

Exit Criteria Of

1

QA Plan Approval

Ritsol_QA_Planning_Procedure

2

Request for audit

The calling procedure that has a need for instant audit

Inputs

No

Input

Coming from/Output Of

1

Approved Quality Assurance Plan

Ritsol_QA_Planning_Procedure

2

Approved Audit Checklists

Ritsol_QA_Planning_Procedure

Activities

No

Activity

Responsible

Input

Output

Temp/Form

1

Conduct the process and work products audit session using the agreed upon audit criteria.

QAR, Audit and Process Owner

Approved Audit Checklists

Audit Findings

 

 

2

Document the audit findings.

 

QAR

Audit Findings

Documented Findings

Ritsol_QA_ Non-compliance_ and_

Corrective_ Action_ Form

3

Communicate the findings to the processes’ owners, work products’ authors and PM.

QAR

Documented Findings

Communicate Findings

 

4

Investigate possible root causes.

Audit/ Process Owner

Communicate Findings

Identified Root Causes

 

5

Determine the suitable corrective action, preventive action (optional) and closure criteria to resolve the deviation.

Audit / Process Owner (and PM, QAR, QAM)

Communicate Findings

Identified Corrective Actions and Closure Criteria

Ritsol_QA_ Non-compliance _ and_

Corrective_ Action_ Form

6

Prepare the QA audit report to enable the NCs follow-up.

QAR and Audit / Process Owner

Identified Corrective Actions and Closure Criteria

Initial QA Plan

 Ritsol_QA_ Non-compliance _ and_

Corrective_ Action_ Form

 

7

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

PR

As per the process

As per the process

As per the process

8

Conduct QA audit as per the QA process and plan.

QAR

As per the process

As per the process

As per the process

9

Conduct CM activities as per the CM process and plan.

CM

As per the process

As per the process

As per the process

10

Collect measurements as per the measurement plan.

MC

As per the process

As per the process

As per the process

11

Approve the outputs of the procedure.

SM

Identified Corrective Actions and Audit Report

Approved Corrective Actions and Audit Report

 

Outputs

No

Output

Going To/Input Of

1

Approved Corrective Actions

Ritsol_QA_Follow-up_Procedure

2

Approved Audit Report

Ritsol_QA_Follow-up_Procedure

Exit Criteria (AND)

No

Criteria

Entry Criteria Of

1

Corrective Actions Approval

Ritsol_QA_Follow-up_Procedure

2

Audit Report Approval

Ritsol_QA_Follow-up_Procedure

Metrics

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

·         Actual versus planned time and effort

·         Actual percentage of processes to be audited (Auditing Coverage Ratio).

·         Actual percentage of work products to be audited (Auditing Coverage Ratio).

Subjects for Review

·         None

Records

·         Non-compliances and corrective actions

·         Audit report

Configurable Items

·         None

 

 

 

 

Quality Management System (QMS)