An overview of ASQ Quality Auditor (CQA) certification program with tips for passing exam
http://seetharamkandarpa.webnode.in/news/web-series-session-1-overview-of-asq-certified-quality-auditor-conducted-on-21-may-2017/
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
An overview of ASQ Quality Auditor (CQA) certification program with tips for passing exam
http://seetharamkandarpa.webnode.in/news/web-series-session-1-overview-of-asq-certified-quality-auditor-conducted-on-21-may-2017/
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
Performance metrics are an essential element of the management review process.
Quality metrics may include elements such as customer satisfaction, supplier performance, manufacturing defects, complaints, cycle times and many other internal or external processes.
This presentation provides a framework for establishing right quality indicators for evaluating the performance of the quality system.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
ICH Q10 GUIDELINES (PHARMACEUTICAL QUALITY SYSTEM)
- Contents
- ICH
- ICH GUIDELINES
- Objective
Q10 GUIDELINE
- Introduction
- Scope
- Objective of Q10 Guideline
- Elements
- CAPA System
- Change Management System
- Continual improvement of pharmaceutical quality system
- References
THANK YOU :)
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs)
used as starting materials in the production of these products is subject to strict good
manufacturing practice regulations that are designed to ensure their quality, safety and
efficacy. This ensures that patients worldwide and at any time can have confidence in the
quality, safety and efficacy of medicines.
The cGMP regulations for final medicinal products are clearly defined in each country
and region. The content of the regulations may vary but the objectives are the same:
- To deliver high quality, safe medicines manufactured and distributed following
controlled procedures to treat diseases and
- To prevent deaths, serious illnesses, adverse events or product recalls resulting from
deficiencies in the manufacturing and distribution processes.
While in the vast majority of cases, the pharmaceutical industry, under the oversight of
the Regulatory Authorities and inspectorates consistently applies appropriate cGMP
practices,
The presentation depicted herein presents briefly an introduction of acceptance sampling along with some major differences amongst the widely used sampling standards.
Acceptance Sampling standards comparison. MIL-STD-105E, MIL-STD-1916, ISO 2859, ISO 3951. About AQLs and OC Curves.
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
Conduct, record & analyse Internal Process Potential Audits.
Allow distribution to your Suppliers for Self Audit.
Enable your Suppliers to report Self Audit Results back to you.
Conduct Process Feasibility Audits on your Suppliers.
Report Supply Chain Process Potential Audit results to your Customers.
Eliminate Rating Discrepancies.
Build Audit Question Databases.
Schedule Routine & Special Audits.
Prioritise Corrective Actions on yourselves and your Suppliers.
Gain Preliminary Results of Full Process Audits.
A good overview of the ASQ Certified Quality Engineer (CQE) exam including subjects covered, subjects requiring special instruction, tips for test preparation, and resources for training.
This presentation gives a thorough overview of the certified quality auditor (CQA) exam offered by the American Society for Quality (ASQ). The overview covers content of the exam, hints for passing the exam, tips for exam preparation, and a resource for exam preparation.
Performance metrics are an essential element of the management review process.
Quality metrics may include elements such as customer satisfaction, supplier performance, manufacturing defects, complaints, cycle times and many other internal or external processes.
This presentation provides a framework for establishing right quality indicators for evaluating the performance of the quality system.
WHO has recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.
These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.
The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:
Appendix 1: Validation of heating, ventilation and air-conditioning systems - will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update - working document QAS/15.639/Rev. 1)
Appendix 2: Validation of water systems for pharmaceutical use - will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems
Appendix 3: Cleaning validation - consensus to retain
Appendix 4: Analytical method validation - update in process
Appendix 5: Validation of computerized systems - update in process
Appendix 6: Qualification of systems and equipment - update in process
Appendix 7: Non-sterile process validation - update already published as Annex 3, WHO Technical Report Series, No. 992, 2015
Comments on this draft document are due by July 12, 2016.
A presentation on this guidance is given below:
Presentation on New WHO Guidance on Validations
ICH Q10 GUIDELINES (PHARMACEUTICAL QUALITY SYSTEM)
- Contents
- ICH
- ICH GUIDELINES
- Objective
Q10 GUIDELINE
- Introduction
- Scope
- Objective of Q10 Guideline
- Elements
- CAPA System
- Change Management System
- Continual improvement of pharmaceutical quality system
- References
THANK YOU :)
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs)
used as starting materials in the production of these products is subject to strict good
manufacturing practice regulations that are designed to ensure their quality, safety and
efficacy. This ensures that patients worldwide and at any time can have confidence in the
quality, safety and efficacy of medicines.
The cGMP regulations for final medicinal products are clearly defined in each country
and region. The content of the regulations may vary but the objectives are the same:
- To deliver high quality, safe medicines manufactured and distributed following
controlled procedures to treat diseases and
- To prevent deaths, serious illnesses, adverse events or product recalls resulting from
deficiencies in the manufacturing and distribution processes.
While in the vast majority of cases, the pharmaceutical industry, under the oversight of
the Regulatory Authorities and inspectorates consistently applies appropriate cGMP
practices,
The presentation depicted herein presents briefly an introduction of acceptance sampling along with some major differences amongst the widely used sampling standards.
Acceptance Sampling standards comparison. MIL-STD-105E, MIL-STD-1916, ISO 2859, ISO 3951. About AQLs and OC Curves.
The Checklist contains explanations and recommendations that:
- Facilitate the audit;
- May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
- Allow for QMS self-assessment for compliance with ISO 9001: 2015;
- Facilitate learning and understanding of the new version of ISO 9001:2015 requirements
- User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
- 72 pages
Conduct, record & analyse Internal Process Potential Audits.
Allow distribution to your Suppliers for Self Audit.
Enable your Suppliers to report Self Audit Results back to you.
Conduct Process Feasibility Audits on your Suppliers.
Report Supply Chain Process Potential Audit results to your Customers.
Eliminate Rating Discrepancies.
Build Audit Question Databases.
Schedule Routine & Special Audits.
Prioritise Corrective Actions on yourselves and your Suppliers.
Gain Preliminary Results of Full Process Audits.
A good overview of the ASQ Certified Quality Engineer (CQE) exam including subjects covered, subjects requiring special instruction, tips for test preparation, and resources for training.
This presentation gives a thorough overview of the certified quality auditor (CQA) exam offered by the American Society for Quality (ASQ). The overview covers content of the exam, hints for passing the exam, tips for exam preparation, and a resource for exam preparation.
American Society for Quality (ASQ) certifications Overviewkushshah
American Society for Quality (ASQ) Certification Overview Presentation - This presentation provides overview of 17 globally recognized certifications to guide you in selecting the right certification(s) for you to pursue. There is one pager for each of the certification that describes key aspects of that certification.
Revitalizing our ASQ Section from Near CollapseJohn Scheftic
This presentation shows how our ASQ Section was turned around and revitalized. I happened to attend the committee meeting to volunteer my help when they were deciding to close down the section.
This presentation is mostly compiled from ASQ Future of quality studies 2008 and Quality Progress articles. I have also added my thoughts on implications and enhanced skills slides.
ASQ Peru Country Counselor presentation at 2016 1st meeting with ASQ Peru members. Held in Lima on February 5, 2016 at Alameda y Hacienda Club.
Presentación del Country Counselor ASQ Perú a los miembros de ASQ Peru en la Alameda y Hacienda Club
The March 2015 Q&A Medical Coding Webinar from Certification Coaching Org, also known as www.codingcertification.org, discussed a variety of topics of interest to outpatient, inpatient, and HCC medical coders including J1 Status Indicator; Bilateral, Multiple Surgery; LVAD/RVAD for CV Surgery; ICD9 Sequence for OV; Skin Grafts; Pathology Consultation Coding; Modifier 58, 59; HCC Coding Question 250.xx; and BCCA Excision Advancement Flap.
Certification Coaching Org’s product offerings were briefly discussed including an upcoming webinar on “Modifiers – It’s All about the Money” and the Replay Club which allows members to review past monthly webinars and obtain CEUs. Attendees’ questions on various coding topics were answered. Educational topics were presented by Alicia Scott, CPC, CPC-I, Laureen Jandroep, CPC, CPC-H, CPC-I, CMSCS, CHCI, CPPM, and Tammy Lucus, CIC, CPC, COC, CPC-I, CPMA. The host for the webinar was Boyd Staszewski.
How to Prepare for ASQ Calibration Technician (CCT) Exam?Meghna Arora
Click Here---> https://bit.ly/3HFBYpa <---Get complete detail on CCT exam guide to crack Technician. You can collect all information on CCT tutorial, practice test, books, study material, exam questions, and syllabus. Firm your knowledge on Technician and get ready to crack CCT certification. Explore all information on CCT exam with number of questions, passing percentage and time duration to complete test.
The April 2016 Q&A Medical Coding Webinar from Certification Coaching Org (CCO), www.cco.us, discussed a variety of topics of interest to outpatient and inpatient medical coders. The topics discussed included 2016 HCPCS Changes for IUD Placement, “First Credential to Go For: Medical Biller or Coder?”, Excludes Notes in ICD-10-CM, Coding Ulcers of the Amputation Stump, Best Practice Coding Tips for Obesity Weight Management, Integumentary ICD-10-CM Skin Issues, and
CABG Coding Review. The CCO VIP opportunity was also discussed. Attendees’ questions on various coding topics were answered. Educational topics were presented by Jo-Anne Sheehan, CPC, CPC-I, CPPM; Alicia Scott, CPC, CPC-I, CRC; and Laureen Jandroep, CPC, CPC-I, COC, CMSCS, CHCI, CPPM. The host for the webinar was Boyd Staszewski.
The educational topics presented during the October 2016 Q&A Webinar included Cranioplasty with Autograft and Add-on Code Incision and Retrieval of Subcutaneous Cranial Bone Graft, Practice Manager Role in Managing Write-Offs, ICD-10-CM: Hypertension and Heart Disease, ICD-10-CM Possible Diagnosis in Outpatient Setting, Anesthesia: Hernia Repairs on Infants (00834 – 00836), Decompression of Meniscal Cysts, Physical and Occupational Therapy Examples (code 97535), and The Ins and Outs of GI Scopes. New pricing for the CPC Blitz was also discussed, as well as the BHAT™ Technique. Laureen Jandroep also reminded attendees about her “Facebook Live” called “Live with Laureen” which views Tuesdays at about 10 a.m. Eastern time and “Did You Know CCO” which Chandra Stephenson presents on Wednesdays at 2 p.m. Eastern. Information about CCO Remote Presentations for local chapters was also mentioned. Attendees’ questions on various coding topics were answered. Educational topics were presented by Jo-Anne Sheehan, CPC, CPC-I, CPPM; Chandra Stephenson, CPC, CIC, COC, CPB, CPCO, CPMA, CPPM, CRC, CPC-I, CCS, CANPC, CCC, CEMC, CFPC, CGSC, CIMC, COBGC, COSC; Alicia Scott, CPC, CPC-I, CRC; and Laureen Jandroep, CPC, CPC-I, COC, CMSCS, CHCI, CPPM. The host for the webinar was Boyd Staszewski.
The June 2015 Q&A Medical Coding Webinar from Certification Coaching Org (CCO), www.cco.us, discussed a variety of topics of interest to outpatient and inpatient medical coders. Topics included Medicare Physicals, Modifier QW, Back to Basics - Cardio, Ejection Fraction, Epileptic Seizure Coding, E/M 2 of 3 Office Established Patient, Inpatient vs. Outpatient Coding, Search Tools & Bubble Highlighting. Certification Coaching Org’s product offerings, the CCO Replay Club which allows members to review past monthly webinars and obtain CEUs, and Certification Coaching Org’s CEU offerings were also discussed. Attendees’ questions on various coding topics were answered. Educational topics were presented by Jo-Anne Sheehan, CPC, CPC-I, CPPM; Alicia Scott, CPC, CPC-I, CRC; and Laureen Jandroep, CPC, CPC-H, CPC-I, CMSCS, CHCI, CPPM. The host for the webinar was Boyd Staszewski.
The August 2016 Q&A Medical Coding Webinar from Certification Coaching Org (CCO), www.cco.us, presented a variety of topics of interest to medical coders and billers. Topics included Transitional Care Management (TCM) – Medical Decision Making (MDM) Leveling, Breast Cancer: Specific Details Now Required, Wound Care Centers, HTN: Controlled vs. Uncontrolled, Abdominal Aortic Aneurysm Repair Coding, and Cardiac Cath Clarification - Congenital Defects. The CCO VIP opportunity and CCO’s Lunch & Learn Coding on FB Live, were also discussed. Attendees’ questions on various coding topics were answered. Educational topics were presented by Jo-Anne Sheehan, CPC, CPC-I, CPPM; Chandra Stephenson, CPC, CIC, COC, CPB, CPCO, CPMA, CPC-I, CCS, CANPC, CEMC, CFPC, CIMC, CGSC, COSC, CRC, CCC; Alicia Scott, CPC, CPC-I, CRC; and Laureen Jandroep, CPC, CPC-I, COC, CMSCS, CHCI, CPPM. The host for the webinar was Boyd Staszewski.
Similar to Tips For Passing Asq Certification Exam Asq (11)
ASQ TR 2:2018, a useful Cost of Quality (COQ) standard provides detailed guidelines on COQ development, implementation and monitoring to improve quality and performance. Making use of this standard—in tandem with ISO 10014:2021—can help organizations realize financial and economic benefits from their quality management system (or other management systems). In this presentation we will explore why building quality at the source and COQ measurement is beneficial to an organization. We will also address guidance for effective implementation of COQ. Participants will also understand major failure modes, and lessons learned from past implementations.
Quality Management - Guidelines for realizing financial and economic benefitsGovind Ramu
Presentation summary
Quality Management System (QMS) is often misperceived as a paperwork exercise done to ensure the organization has an ISO 9001 certificate hanging on the wall. Perhaps, a contractual obligation. This misperception often results in quality management professionals becoming an easy target for headcount reduction. This shortsighted cost cutting blurs the long-term vision of achieving a sustainable and more resilient organization.
Quality professionals often don’t do a great job of making top management and other interested parties aware of everything quality management encompasses and why it’s important to understand a holistic approach to achieving quality. As a result, top management often sees quality as a transactional activity, not a strategic advantage.
This interactive session will focus on presenting ideas for realizing financial and economic benefits from the quality management system implementation. Effective QMS is "quietly saving" in every area of the organization. These implicit savings aren’t publicized to the organization because they aren’t obvious. I will discuss these savings and receive inputs from the participants. I will also discuss how quality management system is tied to organization's bottom line, innovation and growth.
Integrated Management Systems ASQ Silicon Valley section 0613 april 2017_gr c...Govind Ramu
ASQ Publication: http://asq.org/quality-progress/2017/05/standard-issues/all-together-now.html
There are several benefits to having an integrated management system (IMS). In the long term, an IMS helps improve efficiency by removing redundancies of different management systems. Above all, an organization can benefit from having the ability to understand how all of its business process owners’ actions affect all management systems, opening minds to think more broadly about the life cycle of products and services.
Presented for ASQ India on 3/22/2016 7PM - 8PM IST (6.30 AM -7.30AM PST). Govind will briefly discuss key changes, new requirements and a high level transition plan. The new standard is more aligned with business than ever. However this new standard also bring challenges for auditing. As a QMS manager, auditor or even a practitioner you will be expected to apply this management system standard at work.
ISO 9001:2015 DIS Changes, Requirements and ImplementationGovind Ramu
This presentation discusses new requirements to ISO 9001 based on the Draft International Standard (DIS). Guidance for transition to new revision is proposed for planning, communication and execution.
Overview of the proposed Photovoltaic Solar Quality Management System standardGovind Ramu
The goal of this Technical Specification (standard) is to provide a guideline for manufacturers of PV modules to produce modules that, once the design has proven to meet the quality and reliability requirements, replicate such design in an industrial scale without compromising its consistency with the requirements. Expected timeline for release is June 2015.
1. Tips for passing ASQ Certification Exam
(By avoiding many common mistakes)
Based on Jan 2010 Quality Progress article- Test Run
Govind Ramu, P.Eng,
ASQ CQMgr, CQE, CSSBB, CQA, CSQE, CRE,
ASQ Fellow,
QMS 2000 Principal Auditor IRCA (UK)
Past Section Chair Ottawa Valley- ASQ Canada
http://www.asq.org/sixsigma/about/govind.html
2. ASQ Certification Statistics
Pass Rate by ASQ Certification
(Since Last BOK Change- Special Administrations excluded)
100.00%
90.00%
80.00%
Average 65%
70.00%
60.00%
50.00%
40.00%
30.00%
20.00%
10.00%
0.00%
CQE
CCT
CHA
CMQ/OE
CQA
CSSGB
CBA
CSSBB
CSQE
CQI
CRE
CQIA
CQPA
CQT
3. Common mistakes in Exam Planning
o Overconfidence
o Not reading the body of knowledge (BoK) thoroughly
o Lack of work experience in the BoK sections
o Not understanding the cognitive level for each BoK section
o Not aware of appropriate (authentic) reference materials
o Unaware of exam practice aids such as primers and simulated
exams
o Poor time management during preparation
o Missing the application deadline
o Rescheduling the exam due to a non-emergency reason.
4. Planning Mistakes - Explained
Working in the quality profession for a long period of time can lead some
professionals to assume their practical experience automatically gives them the
knowledge they need to ace a certification exam.
Highlight every keyword and tool mentioned in the BoK, and make sure you
have adequate reference materials.
Most certifications require experience that covers one or more BoK sections. In
our day-to-day responsibilities, very few of us regularly work on every area in a
BoK. We use some areas much less frequently than others.
Exam takers often ignore the cognitive level specified for each section of the
BoK. Paying close attention to the cognitive levels will help you determine the
extent of your planning and preparation.
ASQ’s certification handbooks are the best places to start. If you need
additional assistance, exam-specific primers and CDs are also available.
When budgeting your time to accommodate your strengths and weaknesses,
remember the total amount of preparation time you will need depends primarily
upon your knowledge and experience.
5. Strategy for Exam Preparation- Explained
Working in the quality profession for a long period of time can lead some
professionals to assume their practical experience automatically gives them the
knowledge they need to ace a certification exam.
The best approach is to set out to score much higher than the cutoff score.
Although exact cutoff scores are confidential, my experiences with the process
lead me to believe they are usually less than 85%.
The use of simulated exams and question banks can help you identify
strengths and weaknesses during preparation.
It’s important to answer questions correctly, but it’s just as important to manage
the exam time wisely.
CMQ/OE exam takers should practice writing eight to 10 constructive
responses with a pencil during their preparation to regain legibility and speed.
suggestion is to pick two or three reference books from the list provided for the
specific exam and use those same books for preparation and the exam itself.
Choosing reference books with appendixes covering all of the required
statistical tables and a glossary for the BoK is advisable.
6. Common mistakes in Exam Taking
o Lack of confidence
o Distractions during exam writing, such as noise from
construction or traffic
o Forgetting reference books, stationery, and dictionary
o Using a calculator that is different from the one you used for
practice
o Not reading the questions properly with the emphasis on
keywords
o Not following the 30-60-90 seconds rule
o Referring to open books for almost all questions
o Not enough time for revisions
o Too many changes to previous answers during revisions.
7. Strategy for Exam Taking- Explained
Lack of confidence can result in second-guessing during the exam. Relying too
much on open books during the exam is the result of poor preparation or may
signify a lack of confidence. Taking Simulated Exams during preparation help
improve confidence.
Create a checklist of items to take with you on the day of the exam, including
reference books, statistical tables, a calculator and blank paper for working out
your answers.
First, make sure you consult ASQ’s calculator policy
(www.asq.org/certification/faq/calculator.html). Then, take the same calculator
you used during your preparation.
During preparation, you work on understanding sample questions and start the
practice of underlining the key words in the questions. This underlining
technique helps you focus carefully on those words and block out extraneous
ones.
Many exam takers adhere closely to the 30-60-90 seconds rule. The idea is to
attempt questions one by one and initially answer those you can deal with
quickly. Laboring for five or 10 minutes on your first attempt at any answer will
not be worthwhile if it takes time away from addressing other questions.
9. Common mistakes in Exam Preparing
o Mindset to barely pass, thinking of the cutoff score
o Not knowing weaknesses and strengths prior to the exam
date
o Not having practiced and timed adequately using simulated
exams
o Not practicing writing with pencil (CMQ/OE constructive
response)
o Selecting the wrong open-book materials
o Failing to organize open-book materials
o Not getting adequate rest the night prior to the exam
o Not assessing the travel distance, traffic, roadwork, and other
obstructions that may cause stress
o Not knowing the exam hall location in a huge campus area.