What are they preserving?

Slides:

Advertisements

Similar presentations

Basic Principles of GMP

Advertisements

EMS Checklist (ISO model)

EMS Development Course for Government Agencies Class 7: Communication, Document Control, Records, and Emergency Preparedness and Response Winston-Salem,

Exercise 1 TDT 4235 Tor Stålhane IDI / NTNU. Intro The strength of ISO9001 and many other standards is that they focus on “What shall be done” and leave.

Environmental Management System (EMS)

Understanding the Requirements Qimpro Standards Organization

Good Manufacturing Practices Guilin, PRC Dr AJ van Zyl for Quality Assurance and Safety: Medicines Medicines Policy and Standards Health Technology and.

ISO 9001 : 2000.

EPSON STAMPING ISO REV 1 2/10/2000.

Quality control of raw materials In-process control

ISO 9000 Certification ISO 9001 and ISO

BS EN ISO 14001:2004 Madlen King BSc MSc MIEMA EMS Lead Assessor Lloyd’s Register Quality Assurance Ltd BS EN ISO 14001:2004.

ACT 96 - Indoor Environmental Quality In conjunction with the requirements directed under WI Statute and Administrative Code, school building officials.

Quality Management Systems

The Role of the Internal Auditor for Maintaining System Compliance and Promoting Continuous Improvement Wayne M. Uttke

Inspection Issues in the Analytical Laboratory: An FDA Perspective Yvonne McKnight Chemist US Food and Drug AdministrationPhone: x

ISO 9001:2000 QUALITY MANAGEMENT SYSTEM REQUIREMENTS

Chapter 11 Record-Keeping Procedures. Objective In this module, you will learn: u What kinds of records are needed in a HACCP system u When to record.

Important informations

The MIT/QA Plan Issue W. Reiersen. Terminology 1 Product specification: A document generated by the customer identifying requirements and the inspections.

Exercise 1 Tor Stålhane IDI / NTNU. Intro The strength of ISO 9001 and many other standards is that they focus on “What shall be done” and leave “How.

ISO DOCUMENTATION. ISO Environmental Management Systems2 Lesson Learning Goals At the end of this lesson you should be able to:  Name.

1 IRS Treatment Training. IRS Treatment 2 What will you learn? During this session we will cover: assigning and deploying Treatment Site Resources establishing.

Radiopharmaceutical Production

It was found in 1946 in Geneva, Switzerland. its main purpose is to promote the development of international standards to facilitate the exchange of goods.

Project management Topic 8 Quality Review. Overview of processes Prepare for Quality Review Questions list Meeting Agenda Review Meeting Sign-off Product.

Module 2Slide 1 of 26 WHO - EDM Quality Management Basic Principles of GMP Part One.

1 City of Shelby Wastewater Treatment Division Becomes State’s Second Public Agency to Implement a Certified Environmental Management System CERTIFICATION.

Project co-financed by European Union Project co- financed by Asean European Committee for Standardization Implementing Agency GMP Workshop Kuala Lumpur.

ISO Most Common Problems May 25, 2000 Underwriters Laboratories Inc. May 25, 2000 Underwriters Laboratories Inc.

Most Common Deficiencies Cheryl O. Morton Managing Director, AIHA Laboratory Accreditation Programs, LLC.

INGAA Quality Management Systems White Paper Supporting Pipeline Construction.

WORKSHOP ON ACCREDITATION OF BODIES CERTIFYING MEDICAL DEVICES INT MARKET TOPIC 6 CH 5 ISO MANAGEMENT RESPONSIBILITY Philippe Bauwin Medical.

Raaj Unocal Standard Operating Procedures Production planning and control.

R equirements of I SO Clause 5 5. Management responsibility  5.1 Management commitment -Top management shall provide evidence of its commitment.

QUALITY CONTROL FOR NFI

Why LPA’s? LPA’s can provide low cost system for finding problems and making improvements in Safety, Quality, Delivery, Cost and Morale when used effectively.

GS-R-3 vs. ISO 9001:2008 Requirements - 4

Quality Management Process

Chapter 11 Record-Keeping Procedures.

Documentation –Part 2 Basic Principles of GMP Pharmaceutical Quality,

Evaluation of Suppliers of Critical Consumables, Supplies and Services Section February 2016.

Lesson 5: BRITE Seminar: GMP II

Introduction to GMP.

Punch list / Close Out - Project Completion

Quality Control SOP 3.12 Release Date: 08/10/2015.

QUALITY MANAGEMENT SYSTEM

Determining Effectiveness of Internal Audits Presented by: Tony Gutierrez R. Darrell Taylor Minneapolis, MN July 19 & 20, 2012.

Presented by: Michelle Johnston Quality System Consultant

PAI Preparation and Readiness

UNDERSTANDING FOR STANDARD

EMS Checklist (ISO model)

Customers Customers Input Output Product

Management Representative

ISO 9001:2000 Awareness & Implementation Course

Determining Effectiveness of Internal Audits Presented by: Tony Gutierrez R. Darrell Taylor Minneapolis, MN July 19 & 20, 2012.

Company Name Date By Whomever

How to conduct Effective Stage-1 Audit

ISO-9001:2000 Quality Management Systems

Food Technology Industrial Training Flowchart of activities

EMS Development Course for Government Agencies

Why LPA’s? LPA’s can provide low cost system for finding problems and making improvements in Safety, Quality, Delivery, Cost and Morale when used effectively.

ISO 9001:2000 Management System Overview

Why LPA’s? LPA’s can provide low cost system for finding problems and making improvements in Safety, Quality, Delivery, Cost and Morale when used effectively.

ESS High Beta Cavities Quality Assurance and Control - Learning and Planning Workshops, CEA Saclay, 30 June - 1 July 2016 Mark Pendleton STFC, Daresbury.

ISO 9001 – 2008 Changes Summary of Changes

PREPARING FOR THE AUDIT

Radiopharmaceutical Production

Company Name Date By Whomever

Presentation transcript:

What are they preserving? Rockers’ SOP, Policy, WI, specification… What are they preserving?

If you can Show me time, You can also Show me quality

SOP-QC-02 environmental monitoring Inspection of environment and machine surfaces by swapping test (WI-QC-01) Meeting specification? yes Keep record, FR-QC-01 No Retest this batch finished products to Confirm sanitary status (refer SOP-QC-01) Inform cleaning/sanitizing team And issue cleaning/sanitizing request FR-QC-02 Finished products Meet spec? No Reject and keep record (FR-QC-01) and Place products in non-conformance Area (see SOP-PT-05) yes Proceed as usual For training use only

4.2.3 Documents required By the QMS shall be controlled. A documented procedure shall Be established to define the Controls needed; To approve documents for’ Adequacy prior to issue (b) … (c) …

5.6.1 Top management shall Review the organization’s QMS, At planned intervals, to ensure Its continuing suitability, adequacy And effectiveness.