The following document templates (tool kits) are provided totally complimentary, free of charge to use as a starting point for Management Representative. As each business is different, additional documents or revisions would be required to meet your organization’s specific needs, requirements, context, risk profile, etc. If after reading through all of these documents, you feel like you still need a consulting partner to help you develop your new documents – Contact Us. We’re always looking for interesting new clients and projects.
1. Document Change Request
Requestor: DCR No.: Department: Date: Document code: Rev. No: Document title: Rev. Date: |
NATURE OF CHANGE REQUIRED: |
INSTEAD OF: |
SIGNATURE OF REQUESTOR |
CHANGE REVIEW REMARKS: |
APPROVED BY |
CHANGE INCORPORATED IN DOCUMENT: Yes /No MASTER COPY UPDATE: Yes /No Revision No: Revision Date: SIGNATURE OF MANAGEMENT REPRESENTATIVE |
Iss.No./Date: XX/XX.XX.XXXX Rev.No/Rev.Date: XX/XX.XX.XXXX |
2. New Document Request
Requester: NDR No.: Department: Date: |
DOCUMENTED REQUIRED: |
DETAILS: |
SIGNATURE OF REQUESTOR |
NAME OF THE ORIGINATOR: DECISION: ACCEPTED /REJECTED APPROVED BY |
REQUIREMENTS INCORPORATED IN DOCUMENT: Yes /No MASTER LIST UPDATE: Yes /No Document No: Revision No: Revision Date: SIGNATURE OF MANAGEMENT REPRESENTATIVE |
Iss.No./Date: XX/XX.XX.XXXX Rev.No/Rev.Date: XX/XX.XX.XXXX |
3. Document Control and Issue Register
Sl No. | Description of Document | Doc No. | Issue# / Rev # | Copy # | Issued To | Receivers’s Sign | Date | Status of Doc. | Withdrawal | Remarks |
Managing Director | ||||||||||
Management Representative | ||||||||||
Operational Manager | ||||||||||
QA/QC Department | ||||||||||
Maintenance | ||||||||||
Sales | ||||||||||
Procurement | ||||||||||
Human Resource | ||||||||||
HSE | ||||||||||
4. Quality System Documents Amendment Register
Sl No. | Description of Document | Doc No. | Current | Previous | Amendments | Remarks | ||||
Issue# | Rev # | Date | Issue# | Rev # | Date | Details of changes | ||||
5. Annual Internal Audit Plan/Annual MRM Plan
Month / Week | JAN | FEB | MAR | APRIL | MAY | JUN | JUL | AUG | SEP | OCT | NOV | DEC |
I | ||||||||||||
II | ||||||||||||
III | ||||||||||||
IV | ||||||||||||
Prepared by | Approved by | |||||||||||
Date | Date | |||||||||||
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: xx/xx.xx.xxxx |
6. Annual Internal Audit Schedule
Department | Auditee | Auditor | Scope of the audit | Time | Date |
Prepared By: | Approved By: | ||||
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: xx/xx.xx.xxxx |
7. Internal Audit Report
Date: – | Dept: | Auditor: | Auditee: | |||||
+ Obs: Positive Observation | OI: Opportunity for Improvement | MN – NC: Minor Non Conformance | MJ – NC: Major Non Conformance | |||||
Sr. No. | Standard Reference | Audit Questionnaire | Audit Questionnaire | Compliance Type | ||||
+ Obs | OI | MN – NC | MJ – NC | |||||
Auditors Signature: | Auditee : Signature: | |||||||
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: xx/xx.xx.xxxx |
8. Internal audit summary report
To: | |
Cc: | |
From: | |
Date: | |
Audit Description: | |
Executive Overview | |
Audit Objective and Scope | |
Audit Team | |
Criteria | |
Positive Observations | |
Repeated Findings | |
Audit Findings | |
Recommendations | |
Corrective Action Status | |
Signature Management Representative: | Date: |
Iss.No./Date: xx/xx.xx.xxxx | |
Rev.No/Rev.Date: xx/xx.xx.xxxx |
9. Non Conformance Report
Originator | NCR Number | |||
Reference | NCR Date | |||
Department | Auditee | |||
N. C Findings : MAJOR/ MINOR | ||||
| ||||
Signature & Date of Orignator: | Auditee signature | |||
Root cause and correction of non-conformance | ||||
Root Cause : | ||||
| ||||
CORRECTION: | ||||
| ||||
CAR Agreed By: Name/ Title | ||||
Signature & Date: | ||||
Corrective Action: | ||||
| ||||
QA/QC Manager : Sign & Date | Target date of completion : | |||
Follow-up audit: Verification of correction and corrective action | ||||
| ||||
QA/QC Manager : Sign & Date | ||||
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: xx/xx.xx.xxxx |
10. NonConformities Tracking Sheet
Sl No. | Departments/Areas | Non Conformance Report | NCR Number | Type | Date | Auditees | Auditors | Status | MR Sign. |
11 MANAGEMENT REVIEW MEETING MINUTES
Management Review Meeting Agenda
- Quality Policy
- Quality Objectives & Targets
- Effectiveness of actions resulting from previous management reviews
- Results of Audits
- Changes that could affect the quality management system, including changes to legal and other applicable requirements (such as industry standards)
- Analysis of customer satisfaction, including customer feedback
- Process performance
- Results of Risk assessment
- Status of corrective and preventive actions
- Analysis of supplier performance
- Review of analysis of product conformity, including nonconformities identified after delivery or use
- Recommendations for improvement
Venue: | ||||||
Date: | ||||||
Period: | ||||||
Time: | ||||||
PARTICIPANTS | ||||||
Absentees : | ||||||
Management Representative: | ||||||
Sno. | Topic discussed | Review of Topic | Decision on Implementation | Improvement / Corrective action | Responsibility | Time frame |
A. | Follow-up actions from previous management reviews | |||||
B. | Results of Audits | |||||
Internal Quality Audit | ||||||
External Quality Audit | ||||||
C | Customer Audit | |||||
Customer Feedback | ||||||
Customer Complaints | ||||||
D | Results of risk assessment | |||||
E | Process performance and product conformity | |||||
Monthly Outgoing Inspection Report | ||||||
Continual Improvement Plan | ||||||
F | Status of Corrective & Preventive Action | |||||
G | Supplier Performance | |||||
H | Changes that could affect the Quality Management | |||||
Organizational Structure | ||||||
Customer specific requirements | ||||||
Legal & other applicable requirements | ||||||
Certification Council | ||||||
I | Achievement of Objectives and Targets | |||||
Quality Policy | ||||||
Quality Objective | ||||||
Staff Training needs review | ||||||
J | Review of all elements of the entire Quality System | |||||
Review of Quality Manual | ||||||
Organization Chart | ||||||
Calibration Frequency review | ||||||
Timely Invoicing Review | ||||||
Resources needs for personnel | ||||||
Product related to customer requirements | ||||||
Recommendations for improvement | ||||||
Effectiveness of all elements in the entire quality management system and its processes | ||||||
Prepared by Approved by | ||||||
Issue No. / Date : xx/ xx-xx-xxxx Rev. No. / Date : xx/ xx-xx-xxxx |
12. Action Plan
Sl.No. | What | Where | Which | How many How much | Why do (Cause) | How to do (Method) | Who | When |
Prepared by: Approved by: | ||||||||
Issue.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date: xx/xx.xx.xxxx |
13) NC Closure – Verification Checklist
NC # | Date: |
Root Cause Analysis Addressed? | Yes/ NO |
Actions Taken to Correct Nonconformity Addressed? | Yes/ NO |
Actions Taken to Minimize Recurrence Addressed? | Yes/ NO |
Documents Revised As Part of Corrective Action? | Yes/ NO |
Training Performed As Part of Corrective Action? | Yes/ NO |
Training Effectiveness Determined? | Yes/ NO |
Corrective Action Closed & Determined to be Effective? | Yes/ NO |
Record Objective Evidence Include revised documents, training dates, closure dates, effective dates and any other relevant information |
Name of the Management Representative: |
Signature of the Management Representative : |
Date: |
14) QMS Self Assessment form
1 | Is your department working efficiently? | |
1a | If not why? | |
1b | What is recommendation? | |
2 | Do you have enough resources? | |
2a | If not describe. | |
3 | Is the applicable section of the QMS is relevant within your department? | |
3a | If not describe. | |
4 | Is there any customer complaints due to your/department failure? | |
4a | If yes, what corrective action taken? Is it effective? | |
5 | What is your recommendation for overall improvement of the QMS? | |
Date of analysis: | ||
Name of customer: | ||
No of order carried out during last 3 months: |
15) Record of Management of Change
Process/Process Area: Initiated or Identified by: | MOC No. | ||||
Date: | |||||
CHANGE IN THE SYSTEM NEEDED | |||||
Proposed or identified change | Present Process/Function | ||||
| |||||
MOC PROCESS | |||||
Change in Organizational Structure Yes No Change in Critical Supplier Yes No Change in Key Personnel or Essential Personnel Yes No Change in Management System Procedure Yes No Others, Please Specify: | |||||
Reviewe by : | Management Representative (MR) | Date: | |||
RISK ASSOSCIATED WITH THE CHANGE | |||||
# | Risk | Impact on | Significance | Action/Elimination/ Mitigation | |
High (H) Medium (M) Low (L) | |||||
1 | |||||
2 | |||||
3 | |||||
4 | |||||
5 | |||||
Note: High = Required change in QMS, process, technology, knowledge, personnel or supply chain partners/process, time constrains Medium = Required implementation, resources planning/allocation, or training but possible within the set time frame; Low = none of H or M | |||||
RECOMMENDED / NECESSARY ACTIONS FOR THE MITIGATION OF RISK | |||||
# | Action | Target | Responsibility | ||
1 | |||||
2 | |||||
3 | |||||
4 | |||||
5 | |||||
APPROVED BY: | Date: | ||||
MOC IMPEMENTATION | |||||
# | Action | Status | Comments | ||
1 | |||||
2 | |||||
3 |
16. Risk Assessment & Management
Cross Functional Team | |||||||||||||||||
RA Performed on: | |||||||||||||||||
Prepared by: | Risk Assessement & Management | ||||||||||||||||
Approved by: | Define the process: | Doc No.: SOS / MR / 18 | |||||||||||||||
Process Function | Potential Failure Mode | Potential Effect(s) of Failures | s e v | C l a s s | Potential Cause(s)/Mechanism(s) of Failures | O c c u r | Current Process Controls Prevention | Current Process Controls Detection | D e t e c t | R P N | Recommended Action(s) | Responsibility & Target Completion Date | Action Results | ||||
Requirements | Action Taken | S e v | O c c | D e t | R P N | ||||||||||||
Issue / Rev. No.: | Date: | Summary of Changes: | Reason for Revision | ||||||||||||||
17. Contingency Planning
Sl. No. | Process / Function in the Organization | Identified Critical activity in the Organization | Outcome of Risk Assessment – Identified Risk | Impact | Contingency Plan | Responsibility / Authority | Internal Communication Control | External Communication Control | Remarks | ||||||
What | When | Where | Why | Who | How | How much? | |||||||||
18. Corrective and/or Preventive Action Request
REQUEST RAISED FOR | CORRECTIVE ACTION PREVENTIVE ACTION | TO: | PAR/CAR NO: | DATE: |
Incident Details: | Identified by: (source/employee) | Potential Risk/Opportunity |
|
Action Planned: | Responsibility & Target (for action): | Action Taken: | ||
| ||||
Action Details: | | |||
Completed by (Signature & Date) | Verified & Accepted by: (MR/Top Management) |
Follow-up: | Effectiveness: | Status: Closed / New CAR/PAR | ||
Action Details: | ||||
Completed by (Signature & Date) | Verified & Accepted by: (MR/Top Management) |
19. Quality Performance Analysis Report
- Quality Objectives
S. NO | Department | Objectives | Target | Current Status | Remark |
S. NO | Performance Parameter | Current Status | Remark |
2 | Review of Quality Policy: | ||
3 | Effectiveness of action resulting from previous MRM: | ||
4 | Result of Audits: a) Internal Audit: b) External Audit: | ||
5 | Changes that could affect the quality management system, including changes to legal and other applicable requirements: | ||
6 | Customer Complaints: | ||
7 | Customer Satisfaction Survey Data: | ||
9 | Order Summary (Process Performance): | ||
10 | Internal and External issues, Needs and Expectation of Interested parties, | ||
11 | Results of Risk Assessments and Contingency planning: | ||
12 | Product/service Non conformances, including non conformances identified after delivery or use: | ||
13 | Status of Corrective & Preventive actions: (NCR / NCMR) | ||
14 | Supplier Performance Summary: | ||
15 | Resource needs: a) Quality Improvements: b) Recommendation for Improvement: |
Prepared by: | Approved by: | ||
Name: | Name: | ||
Sign: | Sign: | ||
Date: | Date: |
20 Monthly Key Performance Indicator (KPI)
Department : | Month/Year : | __________ / 20____ | |||||
Person responsible : | |||||||
Sr. No | Task | Completion | Remarks | ||||
Target | Actual | ||||||
Approved By : _________________ | Verified By : ___________________ |
21. Standards User Register
S. No | Description of the Standards | Name | Received on | Returned on | Sign | Remarks |
Iss.No./Date: xx/xx.xx.xxxx Rev.No/Rev.Date:xx/xx.xx.xxxx |
22 Minutes of Meeting
Subject: | ||||
Venue: | ||||
HSE Regulation: | ||||
Minutes taken by: | ||||
Attendee: | Department: | Signature: | ||
Distribution List: | ||||
Agenda: | ||||
Issues | Actions | ||
Actionee | Due Date | Status | |