Reject 10.0 Corrective & Preventative Action Process Anyone Problem Identification Step-1 InitiateOpenClosed Quality Reporting – Across Process Problem.

Slides:



Advertisements
Similar presentations
Understanding Food Safety Management Systems
Advertisements

“The Honeywell Web-based Corrective Action Solution”
ISO 9001:2000 Documentation Requirements
8D Corrective Action. 2 8D Problem Solving & Corrective Action: Initiate 8D Corrective Action D1 - Create Problem Solving Team D2 - Define the Problem.
CIP Cyber Security – Security Management Controls
Understanding the Requirements Qimpro Standards Organization
Chapter 7: Key Process Areas for Level 2: Repeatable - Arvind Kabir Yateesh.
More CMM Part Two : Details.
Process Mapping. Why Flow Chart? To understand a process or system To (visually) depict all key steps in a process or system To compare existing and ‘ideal’
Project management Topic 3 Directing a project. Overview of processes Authorise Initiation Authorisation for Initiation Stage Authorise the Project Contract.
The ISO 9002 Quality Assurance Management System
Quality Management System
Quality Management Systems Chapter 10. Introduction ISO- International Organization for Standardization Founded in 1946, in Geneva, Switzerland Main function.
Chapter 9 - Quality Systems Team #2: Cindy Guthrie, Amy Randolph and Robin Tomer.
Chapter 10: Quality Management Systems Jennifer Sadorus Heather Heller.
Documents and Records-Writing a Quality Manual-Module 16 1 Quality Manual Structure and Contents Quality Manual Structure and Contents - optional.
Quality Assurance/Quality Control Policy
RC14001 ® Update GPCA Responsible Care Committee September 23, 2013.
Prepared by Long Island Quality Associates, Inc. ISO 9001:2000 Documentation Requirements Based on ISO/TC 176/SC 2 March 2001.
ISO 9000 Certification ISO 9001 and ISO
LOGO AA Roundup March 30, Can we have a copy of your procedures? The first question the auditor’s ask:
QMS ISO 9001:2008 Introduction to QMS 9001:2008 and system auditing.
4. Quality Management System (QMS)
Training.
Instructions and forms
4. Quality Management System (QMS)
How to Implement, Process and Administer the Preventive Action Process
Preventive Action Training
Elements of Internal Controls Preventing Fraud, Waste, and Abuse in Urban and Rural Transit Systems.
OHT 19.1 Galin, SQA from theory to implementation © Pearson Education Limited 2004 Controlled documents and quality records Definitions and objectives.
University of Sunderland CIFM03Lecture 3 1 QMS / Standards CIFM03 Lecture 3.
Quality Management System
Quality Management Systems P.Suriya Prakash Final Mech Vcet
Degree and Graduation Seminar Project Management Processes
The Key Process Areas for Level 2: Repeatable Ralph Covington David Wang.
The Role of the Internal Auditor for Maintaining System Compliance and Promoting Continuous Improvement Wayne M. Uttke
Implementing ISO 9001 Our project plan Copyright ©2008 The 9000 Store.
Software Quality Assurance Lecture 4. Lecture Outline ISO ISO 9000 Series of Standards ISO 9001: 2000 Overview ISO 9001: 2008 ISO 9003: 2004 Overview.
THE AUDITOR'S RESPONSIBILITIES RELATING TO FRAUD
Lecture #9 Project Quality Management Quality Processes- Quality Assurance and Quality Control Ghazala Amin.
1 DOE IMPLEMENTATION WORKSHOP ASSESSING MY EMS Steven R. Woodbury
EARTO – working group on quality issues – 2 nd session Anneli Karttunen, Quality Manager VTT Technical Research Centre of Finland This presentation.
1.  Describe an overall framework for project integration management ◦ RelatIion to the other project management knowledge areas and the project life.
Software Project Management
US Department of Energy (DOE) of the Quality Assurance Program of the XXX Program at the ZZZ Site Bob Blyth DOE-NE July xx, 200x DOE-NE Audit.
Lecture 11 Managing Project Execution. Project Execution The phase of a project in which work towards direct achievement of the project’s objectives and.
Version Advanced User Training. Instructions This training module contains additional key concepts that are an extension to the concepts in the.
Inventory tag-out Biodiesel Process Overview Reactor Glycerin Isolated Shipment Lot Shipping sample/test Purchasing Inventory Production Sales Shipping.
Georgia Institute of Technology CS 4320 Fall 2003.
The MIT/QA Plan Issue W. Reiersen. Terminology 1 Product specification: A document generated by the customer identifying requirements and the inspections.
Project management Topic 1 Project management principles.
ESA ODFCB # 4 Peter Granseuer1 ESA ODFCB Charter Peter Granseuer MSM-EOI
A QUALITY IMPROVEMENT TOOL
ST Quality WG I. Béjar Alonso Group Leader’s meeting 6th July.
Internal Auditing ISO 9001:2015
Module 12 - part 1Slide 1 of 15 WHO - EDM Basic Principles of GMP Documentation Part 1 Part One, 14.
WebAuditor Training Kit. Introduction-WebAuditor  Process Automation tool for automating all internal quality audit activities.  Web based tool with.
Response to Reports by Deloitte & Touche and Ernst & Young.
9.0 Nonconforming Product Lifecycle Anyone Problem Identification Step-1 InitiateOpenClosed Quality Reporting – Across Process MRB Case MRB Analysis &
1 QUALITY MANAGEMENT SYSTEM PRESENTATION TO BOTSWANA DRUG ADVISORY BOARD MEMBERS 13 th – 17 th AUGUST 2007.
WORKSHOP ON ACCREDITATION OF BODIES CERTIFYING MEDICAL DEVICES INT MARKET TOPIC 9 CH 8 ISO MEASUREMENT, ANALYSIS AND IMPROVEMENT INTERNAL AUDITS.
BUSINESS PROCESSES MAP
Prepared by Rand E Winters, Jr. ASR Senior Auditor October 2014
UNIT V QUALITY SYSTEMS.
3.0 Internal Audit Process
Managing the IT Function
Guidance notes for Project Manager
ROADMAP TO ISO/TS REGISTRATION
Audit Findings Process
<Organization Name> <Date>
Presentation transcript:

reject 10.0 Corrective & Preventative Action Process Anyone Problem Identification Step-1 InitiateOpenClosed Quality Reporting – Across Process Problem Identification /14/06 CAT Implement Plan Quick-Correction Step-3 (quick response) CAT Implement Plan Prevention Projects Step-3 (longer project) CAT (auditor) Audit Results (effectiveness) Step-4 CAM Closure Reporting Step-5 CAM Reject reject CAM Commits Resources CAT Analysis & Plan CAM Approve / reject Planning Step-2 Customer Dissatisfaction Supplier Problems Detected Problems Product Process Equipment Suggested Improvements Improvement Projects High Value Areas Out-Brief Immediate Action Req’d Determine Root-Cause Plan, Authority & Resources Plan, Authority & Resources Implemented Follow-up Projects High Value Projects Quality Reports Status & Trends CAM: Corrective Action Managers CAT: Corrective Action Team members

Document Approvals Role/Position (Normative) Owner: (informational) Approval Date COOBill McIlwain11/28/06 CTOTerry Boone11/28/06 Role/PositionReviewed By: QARavi Doshi11/27/06 OperationsTed DeYoung11/29/06 MaintenanceDan Rogers11/28/06 Approved By: Document ControlJan Rector11/29/06 Instructions for filling out Document Approval Form 1. Identify the owner of the document who has technical authority for content. 2. Identify the authority required to review and approve (authority role). 3. Identify who acts within required authority for this release. 4. Approval date signifies that Document Control has received acceptance of approval. 5. Document Control has structural control as defined in Preparation & Release of Controlled Documents

Revision History DateRevision No.Modification Reason 11/14/0600Original issue 3/27/07Archived since flow chart is embedded in the corresponding procedure