The document outlines a multi-site management system implementation plan consisting of 5 phases. Phase 1 includes senior leadership training, resource allocation, requirements training, gap assessments, and verification planning. Phase 2 includes risk assessment training and performing risk assessments. Phase 3 includes management system process training. Phase 4 includes analysis of verification results and actions from analysis. Phase 5 addresses structural issues. The plan also includes a summary tracker to track progress across all sites and projects.
Lakshy Management Consultant Pvt. Ltd. provides a 10 step approach to achieving ISO 17025 accreditation for testing and calibration laboratories. The 10 steps include awareness training, developing quality policies and objectives, gap analysis, documentation, implementation, internal audits, management reviews, pre-assessments, corrective actions, and the final accreditation audit. Lakshy assists clients through each step to ensure their organization meets all ISO 17025 requirements and receives accreditation.
Energy Saving Using DMAIC Approach in Milk Plant -A Case StudyIRJET Journal
This document discusses reducing the chilling costs of milk processing at a milk plant through applying the DMAIC methodology. The initial chilling cost was Rs. 0.57 per liter of milk processed. Key factors that increased chilling costs included water leakage, improper production planning, poor equipment maintenance, lack of coordination between production and refrigeration sections, and scaling of ammonia pipes. Data was collected on these critical factors and their impacts. Solutions implemented through DMAIC included improved monitoring, preventative maintenance, minimizing reprocessing, and coordinating production schedules with refrigeration needs. As a result, the chilling cost was reduced to Rs. 0.39 per liter, saving Rs. 0.18 per liter.
The document provides a history of accreditation in the UK, beginning with the British Calibration Service established in 1966. It later merged with another organization to form the National Measurement Accreditation Service in 1985, which was renamed the UK Accreditation Service in 1995. The document also defines accreditation and certification, and explains that accreditation evaluates a laboratory's technical competence according to ISO/IEC 17025. It provides an overview of the requirements for laboratories to achieve and maintain accreditation.
PR_Summary of the supplier audit at chemetall company _ 17.05 .017Masud Rana
An ISO9001 audit was conducted of Chemetall Company and identified several findings. More than 15 minor findings were identified. Key issues included incorrect process flow diagrams, lack of document control, unstable temperature monitoring in warehouses, lack of safety stock evaluations for raw materials, no defined process for handling non-conforming products, poor traceability of products and raw materials, and lack of training records to demonstrate operator competence on process changes. Corrective actions were assigned to address each non-conformance by the due date of June 30, 2015.
This document describes an editable document kit for ISO 17025 calibration laboratory certification. It includes over 100 documents organized into several directories: a quality manual, procedures, SOPs/work instructions/exhibits, blank formats, and an ISO 17025 audit checklist. The document kit provides templates for all required documentation to establish an ISO 17025 compliant quality management system for a calibration laboratory.
The audit report identifies several areas of concern for Techno Excel's quality management system that require correction, including the quality policy, documented information, quality objectives monitoring, internal auditing, management review meetings, risk management, and design and development processes. The client is required to address the critical issues before the stage 2 audit by revising procedures and providing evidence of effectiveness.
Chuck Blair, Regional Automotive Program Manager, and Mike Brannock, Automotive SBU Director, go through the highlights of the changes from TS 16949 to IATF 16949.
Lakshy Management Consultant Pvt. Ltd. provides a 10 step approach to achieving ISO 17025 accreditation for testing and calibration laboratories. The 10 steps include awareness training, developing quality policies and objectives, gap analysis, documentation, implementation, internal audits, management reviews, pre-assessments, corrective actions, and the final accreditation audit. Lakshy assists clients through each step to ensure their organization meets all ISO 17025 requirements and receives accreditation.
Energy Saving Using DMAIC Approach in Milk Plant -A Case StudyIRJET Journal
This document discusses reducing the chilling costs of milk processing at a milk plant through applying the DMAIC methodology. The initial chilling cost was Rs. 0.57 per liter of milk processed. Key factors that increased chilling costs included water leakage, improper production planning, poor equipment maintenance, lack of coordination between production and refrigeration sections, and scaling of ammonia pipes. Data was collected on these critical factors and their impacts. Solutions implemented through DMAIC included improved monitoring, preventative maintenance, minimizing reprocessing, and coordinating production schedules with refrigeration needs. As a result, the chilling cost was reduced to Rs. 0.39 per liter, saving Rs. 0.18 per liter.
The document provides a history of accreditation in the UK, beginning with the British Calibration Service established in 1966. It later merged with another organization to form the National Measurement Accreditation Service in 1985, which was renamed the UK Accreditation Service in 1995. The document also defines accreditation and certification, and explains that accreditation evaluates a laboratory's technical competence according to ISO/IEC 17025. It provides an overview of the requirements for laboratories to achieve and maintain accreditation.
PR_Summary of the supplier audit at chemetall company _ 17.05 .017Masud Rana
An ISO9001 audit was conducted of Chemetall Company and identified several findings. More than 15 minor findings were identified. Key issues included incorrect process flow diagrams, lack of document control, unstable temperature monitoring in warehouses, lack of safety stock evaluations for raw materials, no defined process for handling non-conforming products, poor traceability of products and raw materials, and lack of training records to demonstrate operator competence on process changes. Corrective actions were assigned to address each non-conformance by the due date of June 30, 2015.
This document describes an editable document kit for ISO 17025 calibration laboratory certification. It includes over 100 documents organized into several directories: a quality manual, procedures, SOPs/work instructions/exhibits, blank formats, and an ISO 17025 audit checklist. The document kit provides templates for all required documentation to establish an ISO 17025 compliant quality management system for a calibration laboratory.
The audit report identifies several areas of concern for Techno Excel's quality management system that require correction, including the quality policy, documented information, quality objectives monitoring, internal auditing, management review meetings, risk management, and design and development processes. The client is required to address the critical issues before the stage 2 audit by revising procedures and providing evidence of effectiveness.
Chuck Blair, Regional Automotive Program Manager, and Mike Brannock, Automotive SBU Director, go through the highlights of the changes from TS 16949 to IATF 16949.
This document contains an audit checklist covering 16 clauses related to quality system training. For each clause, there are several audit areas and corresponding regulations. Responsible persons are assigned for each regulation. The document also contains an action plan mapping sheet that assigns process owners and activity coordinators for addressing each clause.
This document outlines the key requirements for document control within an ISO/IEC 17025 quality management system for testing and calibration laboratories. It discusses establishing procedures to control internal documents like manuals and procedures, as well as external documents like standards and regulations. Documents must be reviewed, approved by authorized personnel, and have a master list maintained with current revision status and distribution. Obsolete documents must be removed or marked as such. The document also provides guidance on document changes, document distribution, records retention, and archiving requirements.
This document provides an overview of the timeline and key changes between ISO/IEC Guide 65 and the new standard ISO/IEC 17065 for product, process, and service certification bodies. Some of the main changes discussed include more detailed definitions, separating the selection and determination functions, improved descriptions of evaluation resources and processes, and aligning the management system requirements with ISO standards. The presentation aims to support a harmonized transition to the new ISO/IEC 17065 standard for conformity assessment bodies and other interested parties.
The document contains an implementation plan for IATF 16949:2016 certification over four quarters from May 2017 to April 2018. It includes planning activities such as obtaining management support, establishing an implementation team, defining the organization's context and scope, reviewing quality policies and procedures, and identifying mandatory documentation requirements. Implementation activities involve developing and approving the required documentation, providing awareness training, conducting internal audits and management reviews, and completing stage one and two certification audits to achieve certification.
The document discusses quality audits of quality management systems. It defines a quality audit and explains that the purpose is to ensure compliance with standards and identify opportunities for improvement. It describes the roles and responsibilities of auditors and auditees. The audit process includes developing an audit plan and checklist, performing the audit, documenting any non-compliances, issuing reports, and conducting follow-up. Key elements of a quality audit are independence, preparation, documentation, and verification of corrective actions.
ISO 9001-2015 IATF 16949-2016 Numeric Structure Ramona Kellner
ISO 9001:2015 IATF 16949; 2016
Numeric Structure Changes
Dear quality professionals, just in case you have not already done so for yourself, I am sharing a helpful sheet listing the new numeric structure for the emerging automotive standard. As I’m sure you are aware, there are differences between TS structure and IATF, something to keep in mind when auditing and addressing transition and corrective action. Applying IATF changes now, will confidently make it easier for all to save time effort and resources during this transition as well as current corrective actions as opposed to restarting in a year from now. Enjoy!
Jennifer Perrin has over 19 years of experience in quality systems and regulatory compliance for the pharmaceutical and medical device industries. She holds a Bachelor's degree in Psychology/Biology from Cleveland State University and is a Lean Six Sigma Black Belt. Currently she is the North American Product Stewardship Manager and Global REACH Compliance Manager at PolyOne, where she leads a team and is responsible for regulatory standards and compliance. Previously she held quality assurance and management roles at various contract manufacturers and suppliers where she developed quality programs, managed staff, and interfaced with customers and regulators.
Api q1 6 a monogram-iso audit template- blankBart Mullins
This audit report form is used to audit organizations claiming conformity to API Spec Q1 9th Edition and ISO 9001:2015. It documents audit information such as the facility details, audit scope and criteria, license scope if applicable, quality management system requirements, procedures, and audit findings. Requirements specific to ISO 9001:2015 are highlighted. The auditor evaluates objective evidence to verify conformance and notes any nonconformities.
The document summarizes changes made from ISO/TS 16949 to the new IATF 16949 standard. Key changes include strengthening requirements around product safety, corporate responsibility, process reviews, and risk analysis. A multi-phase revision process was used and over 1,700 stakeholder comments were received. The goal of the changes is to better address quality management system needs in the automotive industry and prevent quality problems.
The document provides a summary of an individual's career accomplishments and experience in various areas including technical, operational, business, project management, manufacturing, quality, supply chain, logistics, training, and IT skills. It also lists accomplishments in reducing metrics related to service turnaround time, on-time delivery, development time, and inventory. Finally, it discusses experience with people and soft skills like performance management, coaching, training, and customer contact.
This document summarizes an 8D report from a supplier to address a problem where concession labels were missing from packaging. It involved the following key steps:
1. An immediate containment action of rechecking all stored parts to identify the scope of the problem and holding further deliveries.
2. Forming a team to define the problem of missing concession labels and develop a containment action of rechecking all stored parts.
3. Identifying the root causes as misunderstanding of packaging standards, lack of inspector oversight, and packer not taking packaging seriously.
4. Implementing corrective actions such as establishing a process to track concessions, training on packaging standards, and assigning oversight of information updates.
Double wall Glass Bottle Sourcing Project Case Study by Dragon Sourcing John William
Here is a case study by Dragon Sourcing on Bottle Sourcing Project from consumer goods sector for the year 2014 covering China. For details contact: www.dragonsourcing.com
Case study based on production, financial and social auditsJohn William
This case study focuses on providing necessary information on production, financial and social audits. To know more visit: http://www.dragonsourcing.com/china-sourcing-company/
The document discusses the importance and principles of auditing quality management systems. It defines key audit terms and outlines the audit process, including planning, execution, reporting, and follow-up. Audits are necessary to ensure effectiveness of quality system implementation, evaluate performance, and drive continuous improvement. The audit process involves preparing an audit program and checklists, conducting opening and closing meetings, gathering objective evidence through observation and documentation review, and issuing corrective actions when nonconformities are found.
This document provides a checklist for organizations transitioning from ISO 9001:2008 to ISO 13485:2016 and ISO 9001:2015. It contains tables to validate that an organization's integrated quality management system addresses new concepts in both standards. The tables list clauses from each standard and require evidence that requirements have been met without exceptions. It concludes that a recommendation for certification is dependent on submitting a corrective action plan to address any findings from the audit, or that a special on-site visit may be required if registration cannot be immediately recommended.
This document outlines the stages of a waterfall and agile project lifecycle model. The waterfall model consists of 5 sequential stages: initiation, design, build, deploy, and transition. Each stage has defined exit criteria and deliverables. The agile model takes a cyclical approach, with design, build and deployment occurring in short iterative sprints followed by testing and further iteration until a product is ready for a phased or pilot go-live. Both models aim to progress the project from an initial concept through development and testing to deployment and transition to operations.
Provides an introduction to Lean Management and its application along with video links. The slide also details the improvement cycle with Value added, non-value added and waste in any activity or process. This slide focuses on the time and motion study and how to observe the process. This helps identify process time and determine if the process is value-added. Helps anyone who wants an idea on starting process analysis and continuous improvement in office and factory environments to reduce waste and get cost-effectiveness. Provides an overview of the lean tools and some videos to expand the basic knowledge. Provides a link for the file download for direct observation.
Links for the video & Files
https://www.youtube.com/watch?v=wfsRAZUnonI
https://www.youtube.com/watch?v=yZvsqm4Jok8
https://files.fm/f/2uhf7y8er
https://www.youtube.com/watch?v=PHOppLiEG0o
https://www.youtube.com/watch?v=jmTOuHxc4nE
https://www.youtube.com/watch?v=yOLfe37gq4g
The document discusses techniques for achieving zero equipment failures through planned maintenance. It describes the differences between planned and reactive maintenance. Planned maintenance involves scheduled inspections and repairs, while reactive maintenance only addresses unplanned breakdowns. The document outlines seven steps to implement a planned maintenance program using either an equipment model or parts model approach. This includes evaluating current equipment conditions, improving conditions, developing inspection standards, extending service life, and implementing condition-based maintenance.
This document discusses applying LEAN principles to optimize Pride International's non-manufacturing supply chain processes from purchase order to payment. It describes Pride International and the consulting firm UHY Advisors. It outlines the challenges with Pride's existing vague and siloed procure-to-pay processes and metrics. The strategy involved defining the problem, measuring performance, analyzing inefficiencies, improving processes, and controlling gains. Key activities included mapping the current state, identifying waste, designing an improved future state, piloting changes, and implementing the new processes while instilling a process improvement culture. The pilot demonstrated improvements in key performance indicators like cycle times, rework, and compliance.
This document is a quality assurance screening tool used to evaluate testing materials. It contains three parts: batch screening of test packets, evaluating the rigor of test forms and items, and assessing the overall quality. Part I involves screening test packets to ensure all necessary components are included. Part II examines whether test items are appropriately developed, assigned to standards, and at the right cognitive level. Part III checks that specifications match forms, guidelines are clear, accommodations are addressed, scoring is standardized, and rubrics provide detailed information.
The document discusses BRC certification and its requirements. BRC certification enhances food safety and quality systems. It ensures legal compliance and reduces audit duplication for manufacturers. The BRC Global Standard for Food Safety has 7 sections addressing issues like management commitment, HACCP plans, product control, and personnel training. Sites are audited and receive grades depending on the number and severity of nonconformities found. Production areas are classified based on product risks to ensure proper controls and segregation. Certification requires meeting all fundamental requirements which are crucial for an effective food safety system.
The testing process ensures that selected work products meet their specified requirements through formal testing procedures. This involves developing a testing strategy, plans, cases, and then implementing actual testing. Defects found are reported, logged, and resolved. Metrics are used to track progress and reporting. At the end, a report is created describing the results and acceptance criteria for product release or requiring more work.
This document contains an audit checklist covering 16 clauses related to quality system training. For each clause, there are several audit areas and corresponding regulations. Responsible persons are assigned for each regulation. The document also contains an action plan mapping sheet that assigns process owners and activity coordinators for addressing each clause.
This document outlines the key requirements for document control within an ISO/IEC 17025 quality management system for testing and calibration laboratories. It discusses establishing procedures to control internal documents like manuals and procedures, as well as external documents like standards and regulations. Documents must be reviewed, approved by authorized personnel, and have a master list maintained with current revision status and distribution. Obsolete documents must be removed or marked as such. The document also provides guidance on document changes, document distribution, records retention, and archiving requirements.
This document provides an overview of the timeline and key changes between ISO/IEC Guide 65 and the new standard ISO/IEC 17065 for product, process, and service certification bodies. Some of the main changes discussed include more detailed definitions, separating the selection and determination functions, improved descriptions of evaluation resources and processes, and aligning the management system requirements with ISO standards. The presentation aims to support a harmonized transition to the new ISO/IEC 17065 standard for conformity assessment bodies and other interested parties.
The document contains an implementation plan for IATF 16949:2016 certification over four quarters from May 2017 to April 2018. It includes planning activities such as obtaining management support, establishing an implementation team, defining the organization's context and scope, reviewing quality policies and procedures, and identifying mandatory documentation requirements. Implementation activities involve developing and approving the required documentation, providing awareness training, conducting internal audits and management reviews, and completing stage one and two certification audits to achieve certification.
The document discusses quality audits of quality management systems. It defines a quality audit and explains that the purpose is to ensure compliance with standards and identify opportunities for improvement. It describes the roles and responsibilities of auditors and auditees. The audit process includes developing an audit plan and checklist, performing the audit, documenting any non-compliances, issuing reports, and conducting follow-up. Key elements of a quality audit are independence, preparation, documentation, and verification of corrective actions.
ISO 9001-2015 IATF 16949-2016 Numeric Structure Ramona Kellner
ISO 9001:2015 IATF 16949; 2016
Numeric Structure Changes
Dear quality professionals, just in case you have not already done so for yourself, I am sharing a helpful sheet listing the new numeric structure for the emerging automotive standard. As I’m sure you are aware, there are differences between TS structure and IATF, something to keep in mind when auditing and addressing transition and corrective action. Applying IATF changes now, will confidently make it easier for all to save time effort and resources during this transition as well as current corrective actions as opposed to restarting in a year from now. Enjoy!
Jennifer Perrin has over 19 years of experience in quality systems and regulatory compliance for the pharmaceutical and medical device industries. She holds a Bachelor's degree in Psychology/Biology from Cleveland State University and is a Lean Six Sigma Black Belt. Currently she is the North American Product Stewardship Manager and Global REACH Compliance Manager at PolyOne, where she leads a team and is responsible for regulatory standards and compliance. Previously she held quality assurance and management roles at various contract manufacturers and suppliers where she developed quality programs, managed staff, and interfaced with customers and regulators.
Api q1 6 a monogram-iso audit template- blankBart Mullins
This audit report form is used to audit organizations claiming conformity to API Spec Q1 9th Edition and ISO 9001:2015. It documents audit information such as the facility details, audit scope and criteria, license scope if applicable, quality management system requirements, procedures, and audit findings. Requirements specific to ISO 9001:2015 are highlighted. The auditor evaluates objective evidence to verify conformance and notes any nonconformities.
The document summarizes changes made from ISO/TS 16949 to the new IATF 16949 standard. Key changes include strengthening requirements around product safety, corporate responsibility, process reviews, and risk analysis. A multi-phase revision process was used and over 1,700 stakeholder comments were received. The goal of the changes is to better address quality management system needs in the automotive industry and prevent quality problems.
The document provides a summary of an individual's career accomplishments and experience in various areas including technical, operational, business, project management, manufacturing, quality, supply chain, logistics, training, and IT skills. It also lists accomplishments in reducing metrics related to service turnaround time, on-time delivery, development time, and inventory. Finally, it discusses experience with people and soft skills like performance management, coaching, training, and customer contact.
This document summarizes an 8D report from a supplier to address a problem where concession labels were missing from packaging. It involved the following key steps:
1. An immediate containment action of rechecking all stored parts to identify the scope of the problem and holding further deliveries.
2. Forming a team to define the problem of missing concession labels and develop a containment action of rechecking all stored parts.
3. Identifying the root causes as misunderstanding of packaging standards, lack of inspector oversight, and packer not taking packaging seriously.
4. Implementing corrective actions such as establishing a process to track concessions, training on packaging standards, and assigning oversight of information updates.
Double wall Glass Bottle Sourcing Project Case Study by Dragon Sourcing John William
Here is a case study by Dragon Sourcing on Bottle Sourcing Project from consumer goods sector for the year 2014 covering China. For details contact: www.dragonsourcing.com
Case study based on production, financial and social auditsJohn William
This case study focuses on providing necessary information on production, financial and social audits. To know more visit: http://www.dragonsourcing.com/china-sourcing-company/
The document discusses the importance and principles of auditing quality management systems. It defines key audit terms and outlines the audit process, including planning, execution, reporting, and follow-up. Audits are necessary to ensure effectiveness of quality system implementation, evaluate performance, and drive continuous improvement. The audit process involves preparing an audit program and checklists, conducting opening and closing meetings, gathering objective evidence through observation and documentation review, and issuing corrective actions when nonconformities are found.
This document provides a checklist for organizations transitioning from ISO 9001:2008 to ISO 13485:2016 and ISO 9001:2015. It contains tables to validate that an organization's integrated quality management system addresses new concepts in both standards. The tables list clauses from each standard and require evidence that requirements have been met without exceptions. It concludes that a recommendation for certification is dependent on submitting a corrective action plan to address any findings from the audit, or that a special on-site visit may be required if registration cannot be immediately recommended.
This document outlines the stages of a waterfall and agile project lifecycle model. The waterfall model consists of 5 sequential stages: initiation, design, build, deploy, and transition. Each stage has defined exit criteria and deliverables. The agile model takes a cyclical approach, with design, build and deployment occurring in short iterative sprints followed by testing and further iteration until a product is ready for a phased or pilot go-live. Both models aim to progress the project from an initial concept through development and testing to deployment and transition to operations.
Provides an introduction to Lean Management and its application along with video links. The slide also details the improvement cycle with Value added, non-value added and waste in any activity or process. This slide focuses on the time and motion study and how to observe the process. This helps identify process time and determine if the process is value-added. Helps anyone who wants an idea on starting process analysis and continuous improvement in office and factory environments to reduce waste and get cost-effectiveness. Provides an overview of the lean tools and some videos to expand the basic knowledge. Provides a link for the file download for direct observation.
Links for the video & Files
https://www.youtube.com/watch?v=wfsRAZUnonI
https://www.youtube.com/watch?v=yZvsqm4Jok8
https://files.fm/f/2uhf7y8er
https://www.youtube.com/watch?v=PHOppLiEG0o
https://www.youtube.com/watch?v=jmTOuHxc4nE
https://www.youtube.com/watch?v=yOLfe37gq4g
The document discusses techniques for achieving zero equipment failures through planned maintenance. It describes the differences between planned and reactive maintenance. Planned maintenance involves scheduled inspections and repairs, while reactive maintenance only addresses unplanned breakdowns. The document outlines seven steps to implement a planned maintenance program using either an equipment model or parts model approach. This includes evaluating current equipment conditions, improving conditions, developing inspection standards, extending service life, and implementing condition-based maintenance.
This document discusses applying LEAN principles to optimize Pride International's non-manufacturing supply chain processes from purchase order to payment. It describes Pride International and the consulting firm UHY Advisors. It outlines the challenges with Pride's existing vague and siloed procure-to-pay processes and metrics. The strategy involved defining the problem, measuring performance, analyzing inefficiencies, improving processes, and controlling gains. Key activities included mapping the current state, identifying waste, designing an improved future state, piloting changes, and implementing the new processes while instilling a process improvement culture. The pilot demonstrated improvements in key performance indicators like cycle times, rework, and compliance.
This document is a quality assurance screening tool used to evaluate testing materials. It contains three parts: batch screening of test packets, evaluating the rigor of test forms and items, and assessing the overall quality. Part I involves screening test packets to ensure all necessary components are included. Part II examines whether test items are appropriately developed, assigned to standards, and at the right cognitive level. Part III checks that specifications match forms, guidelines are clear, accommodations are addressed, scoring is standardized, and rubrics provide detailed information.
The document discusses BRC certification and its requirements. BRC certification enhances food safety and quality systems. It ensures legal compliance and reduces audit duplication for manufacturers. The BRC Global Standard for Food Safety has 7 sections addressing issues like management commitment, HACCP plans, product control, and personnel training. Sites are audited and receive grades depending on the number and severity of nonconformities found. Production areas are classified based on product risks to ensure proper controls and segregation. Certification requires meeting all fundamental requirements which are crucial for an effective food safety system.
The testing process ensures that selected work products meet their specified requirements through formal testing procedures. This involves developing a testing strategy, plans, cases, and then implementing actual testing. Defects found are reported, logged, and resolved. Metrics are used to track progress and reporting. At the end, a report is created describing the results and acceptance criteria for product release or requiring more work.
Final Class Presentation on Project Audit and Closure.pptGeorgeKabongah2
Project auditing can be defined as the process of detailed inspection of the management of a project, its methodology, its techniques, its procedures, its documents, its properties, its budgets, its expenses and its level of completion.
This document discusses principles of self-inspection and quality audits in pharmaceutical production. It covers objectives of self-inspection including identifying roles in quality management. Key areas to inspect include production procedures, equipment, materials handling, batch records, and deviations. Effective self-inspection requires defined teams, inspection programs, checklists, reports, and corrective action plans. External audits verify compliance and can include regulatory, contractor, or supplier audits. Auditors should evaluate self-inspection programs and ensure defined processes are followed.
The document provides an overview of 5S implementation at the Littleborough site. It describes the factory and warehouse details. It then outlines the 5S workshops that were conducted, which involved audits, creating visions, sorting, setting, shining, standardizing and sustaining changes. Post-workshop efforts included continued audits, newsletters, and standardizing and sustaining training. The 5S philosophy was then expanded to other areas and sites.
This document discusses deviations in manufacturing processes and their proper handling according to GMP regulations. It defines what constitutes a deviation and differentiates between planned and unplanned deviations. It outlines the obligations to properly document, investigate, and report on deviations to determine their impact. The proper steps for investigating deviations are provided, including determining what happened, who was involved, and identifying the root cause. The importance of corrective and preventive actions is emphasized to prevent future deviations and ensure product quality.
Hany Amer is a Quality Engineer seeking a position improving quality and processes. He has over 15 years of experience in quality control and production engineering roles. His experience includes implementing quality management systems, auditing, process improvement, and resolving customer issues. He has a BSc in Mechanical Engineering and certificates in quality management and Lean Six Sigma.
# 3 PPT - Expose Your Hidden Problems Using Visual ManagementRhonda Kovera
The document discusses using visual management and standard work to drive continuous improvement. It provides examples of how establishing a standard, monitoring for variances from the standard, and problem-solving the variances can create workflow. Specific visual management tools are presented, such as fishbone diagrams, andon lights, accountability boards, and standard work documents, that can be used to establish standards, identify problems, and drive improvements. The overall message is that visual management and standard work are important Lean techniques for exposing problems and waste, and driving continuous process improvement.
The document provides guidance on Codify's peer review process. It describes the 6 main steps: 1) Planning, 2) Overview, 3) Review, 4) Meeting, 5) Rework, and 6) Review & Audit. Key activities include assigning roles, announcing the review, conducting an optional work product overview, performing independent reviews and submitting defect logs, consolidating logs, determining if a review meeting is needed, discussing issues in the meeting, reworking the product, and final verification. Appendices include process diagrams, forms, checklists, and lists of work products and roles.
2. Develop a visit strategy
Set expectations for work completed
Define “work complete”
Detailed plans
Routine updates
Summary reports
Roll-up Summary tracker
• Complete system look
Have complete sets of tools for training
3. Hands On Approach
1. Engagement, Planning, & Initial Start
2. Requirements Review
3. Business Process Training
4. CA/PA & HACCP Process Training
5. Operational Controls / GMP Training
6. Process Audit Training
7. Data/Results Analysis Training
8. Pre-assessment / Corrections Plan
4. 5 Phases
1. Leadership focus
2. High level & department processes
3. System processes
4. Verification and validation
5. Structural issues
Summary Tracker
• Leadership summary
• Roll-ups all projects
5. Item Description
%Complete
Owner
Status
Start
Complete
Target
4/21/2015
4/28/2015
5/5/2015
5/12/2015
5/19/2015
5/26/2015
6/2/2015
6/9/2015
6/16/2015
6/23/2015
6/30/2015
7/7/2015
7/14/2015
7/21/2015
7/28/2015
8/4/2015
Total Projected Implementation Sat, 1/00/00 Sat, 1/00/00
1 Phase 1
Senior Leadership Training 0%
Management System Intro Training for Senior Leaders
Resource Allocation 0%
Identify Food Safey Team Leader / Management Rep
Identify Envirnomental Management System Rep
Identify OHSAS Management System Rep
Responsibility Matrix
Organization Chart
Skill Sets / Job Descriptions
Requirements Training 0%
ISO Requirements Training Management Rep
ISO Requirements Training Staff
PAS Requirements Training Management Rep
PAS Requirements Training Staff
General Workforce Communication
Gap Assessments 0%
Gap Assessment (Management System)
Gap Assessment (PAS/Operational Controls)
Process Flow 0%
Process Flow
Inventory Current Documents
Stage 1 Processes 0%
Establish Management Review (Project Review)
Management Policy Statement
Document & Record Control Processes (SOP)
Training Process (SOP)
Action Item Log Process
Verification Planning 0%
PRP Verification Plan (Work Aid) First Draft
PRP Verification Plan (Work Aid) FST Review
2 Phase 2
Risk Assessment Training 0%
HACCP Training
Risk Assessment & Business Plan Training
Perform Risk Assessments 0%
PRP Risk Assessment
HACCP Analysis
Business & Quality Assessment
Environmental Aspects & Impacts
Safety Risk Assessment
6. Certification Date Phase 1 Responsibility Date Due Status
Develop Plan
Senior Leadership Training
Resource Allocation
Requirements Training
Team Names Signatures Gap Assessments
Sponsor: Process Flow
Lead: Stage 1 Processes
Member: Verification Planning
Member: Summary 0%
Member:
Member: Phase 2 Responsibility Date Due Status
RTM: Risk Assessment Training
MSM: Perform Risk Assessments
Business Planning & Management Review
Food Safety Processes
Status Item Expected Cost Environmental Processes
OHSAS Processes
Production Work
QA/Lab Work
Warehouse Work
Maintenance Work
Summary 0%
Phase 3 Responsibility Date Due Status
Management System Process Training
Management System Processes
Business System Processes
Maintenance System Processes
Management System Verification
Summary 0%
Phase 4 Responsibility Date Due Status
Analysis of Verification Results
Actions From Analysis
#DIV/0! Summary -$ How to use a Management System Training
Preassessment
Corrections from Preassessment
Certification
Attendees Summary 0%
Roadblocks Next Steps Next Visit
Comments
Project Status #DIV/0!
Date Last
Reviewed
Facility Name
Current Plant Status
Plan Goal
Operational Controls & PAS Required Corrections
7.
8. ISO 22000, ISO 9001, ISO 14001, & OHSAS 18001 Approach/Process Records/Evidence Notes
4 Management System
4.1 General requirements
ISO 22000 § 4.1 ISO 9001 § 4.1
ISO 14001 § 4.1 OHSAS 18001 § 4.1
The organization shall establish, document, implement and
maintain and continually improve an effective management
system, which includes quality, food safety, environmental and
safety management. The management system shall be updated
when necessary in accordance with the requirements of the
International Standards of ISO 22000, ISO/TS 22002-1, ISO
9001:2008, ISO 18001:2007, and OHSAS 14001:2004, and shall
determine how it will fulfill these requirements.
Management System
Manual
Manual
Master Document List
Records / Records List
Management Review
The organization shall define and document the scope of its
management system for quality, environmental, and safety.
Management System
Manual
Section 2 of Manual -
Scope
The organization shall define the scope of the food safety
management system. The food safety scope shall specify the
products or product categories, processes and production sites
that are addressed by the food safety portion of the management
system.
Management System
Manual
Section 2 of Manual -
Scope
9. ID Clause Requirement
Processes used to control
Requirement
Verification
Activity
Frequency
Evidence
Record
FST Verification
Method
1
4 Construction and layout
of buildings
4.1 General requirements
Buildings are designed, constructed
and maintained in a manner
appropriate to the nature of the
processing operations that are
carried out, the food safety hazards
associated with those operations,
and the potential sources of
contamination from the plant
environs. Buildings are of durable
construction which presents no
During normal management
routines items are identified
and corrected
GMP
Inspection
Monthly GMP Record Food Safety
Coordinator
Review
2
4.2 Environment Consideration is given to potential
sources of contamination from the
local environment.
During the annual risk
assessment process, FST will
perform a PRP Risk Assessment
to identify changes
PRP Risk
Assessment
Annually Assessment FST Approval
3
4.2 Environment Food production is not carried out in
areas where potentially harmful
substances could enter the product
During the annual risk
assessment process, FST will
perform a PRP Risk Assessment
to identify changes
PRP Risk
Assessment
Annually Assessment FST Approval
4
4.2 Environment The effectiveness of measures taken
to protect against potential
contaminants are periodically
reviewed.
During the PRP Risk Assessment
Process, the controls are rated
and rerated as needed
PRP Risk
Assessment
Annually Assessment FST Approval
5
4.3 Locations of
establishments
The site boundaries are clearly
identified.
Curb, RR Tracks, Outer Walls, Map GMP
Inspection
Monthly GMP Record Food Safety
Coordinator
Review
6
4.3 Locations of
establishments
Access to the site is controlled. Locked doors, gates, e-cards,
receptionist
GMP
Inspection
Monthly GMP Record Food Safety
Coordinator
Review
7
4.3 Locations of
establishments
The site is maintained in good order.
Vegetation is tended or removed.
Roads, yards and parking areas are
drained to prevent standing water and
are maintained.
Vegetation is maintained by
interal persons
Standing water issues are
identified during normal
management routines and action
items are discussed and
corrected
GMP
Inspection
Monthly GMP Record Food Safety
Coordinator
Review
10. #
ID'd
From
Date
Open
Area Item Name Category Sub-Category Item Description Owner Date Due Date Closed
12038 G Mar-12 Quality Bev QC lab Building Materials Ceiling Tiles replace soiled ceiling tiles Steve 4/20/2012 5/11/2012
12016 A Mar-12 Production Floor around can line Building Materials Floors worn down to aggregate Steve 4/15/2012 5/1/2012
12024 G Mar-12 Sugar Room Floor needs repaired Building Materials Floors Sugar Room Steve
12/31/201
2
5/9/2012
12039 G Mar-12 Quality Micro lab Building Materials Lights replace cracked light cover Steve 4/20/2012 5/11/2012
12023 G Mar-12 Warehouse Spot Light Out Building Materials Lights No Dock door #8 Steve 4/20/2012 5/11/2012
12017 A Mar-12 Maintenance Drain cleaning. Documentation Missing no documentation for how to clean and verification Randy 4/15/2012 5/11/2012
12018 A Mar-12 Maintenance Maintenance records Documentation No Records no doc rec for release equip from Maint to prod Joe 4/15/2012 5/11/12
12033 G Mar-12 Premix Premix NW corner stand Equipment Needs Replacing replace rusty stand with stainless/aluminum Steve 4/20/2012 4/12/2012
12011 A Mar-12 KOCON Syrup on ceiling Housekeeping Ceiling Tiles KOCON room Randy 4/7/2012 3/27/2012
12031 G Mar-12 Premix Premix fan Housekeeping Fans south fan needs cleaning Steve 4/20/2012 4/12/2012
12034 G Mar-12 Packaging btl line video jet Housekeeping Not Clean clean ink from around the reflector Steve 4/20/2012
12037 G Mar-12 Packaging can line traymore Housekeeping Not Clean ink stain on floor and railing around coder Steve 4/20/2012
12022 G Mar-12 Warehouse North Dock debris Housekeeping Not Clean Doors #1, 2, 3 Steve 4/20/2012 3/27/2012
12036 G Mar-12 Filler Room Can filler/seamer Housekeeping Panels tile SW corner by elec panel needs cleaning Randy 4/20/2012 4/12/2012
12030 G Mar-12 Production Sledge Blow off panel Housekeeping Panels needs cleaned Randy 4/20/2012 3/27/2012
12019 G Mar-12 KOCON KOCON room Housekeeping Piping pipe above coke tank needs cleaning Randy 4/20/2012 4/5/12
12035 G Mar-12 Packaging case washer Housekeeping Piping white exhaust pipes need to be wiped off Steve 4/20/2012 5/11/2012
12021 G Mar-12 Warehouse Area below roll down rack Housekeeping Racks Needs to be cleaned Steve 4/20/2012 3/27/2012
12025 G Mar-12 Water Treatment RO Softener Housekeeping Tanks/Covers salt tank top is dirty Steve 4/20/2012 3/27/2012
12026 G Mar-12 Water Treatment West Water tmt covers & top Housekeeping Tanks/Covers all need cleaning Randy 4/20/2012
12027 G Mar-12 Water Treatment Ferric Sulfate container Housekeeping Tanks/Covers container and area around it need cleaning Steve 4/20/2012 5/3/2012
12028 G Mar-12 Water Treatment East Water Tmt Housekeeping Tanks/Covers Sand filters tops need cleaning Randy 4/20/2012 4/12/2012
12029 G Mar-12 Water Treatment Lime tank, east water Housekeeping Tanks/Covers top needs scraped…lime build-up Randy 4/20/2012 4/12/2012
12032 G Mar-12 Premix Premix filling area Housekeeping Walls false wall needs cleaning; handprint Steve 4/20/2012 3/27/2012
12015 A Mar-12 Premix Eye wash bottles in premix Materials Containers Not Controlled sitting on top of cabinet…need a rack/holder Joe 4/7/2012 3/27/2012
12014 A Mar-12 Can Crushing Wrongly labeled spray bottles Materials Containers Not ID'd Can crushing room Steve 4/7/2012 3/27/2012
12012 A Mar-12 Production Oil drain jug not labeled Materials Containers Not ID'd Alvey Steve 4/7/2012 3/27/2012
12013 A Mar-12 Production PF&B extension cords Materials Damaged one pulled out and two without caps Steve 4/7/2012 3/27/2012
12010 A Mar-12 Sanitation CIP room outdated bottles Materials Incorrect bottles are refilled Randy 4/7/2012 3/27/2012
12020 G Mar-12 Warehouse DrP not put away at E.O.S Storage Not Stored Prod by no. end of 12-pk rack Steve 4/20/2012 3/27/2012
12040 FSL Mar-12 Admin Bioterrorism Training Missing add to new employee training Joe 4/29/2012 4/13/2012