auditing

12 Strongly Recommended Tasks for Your Risk-Based Thinking / Approach That Will Pass All Audits and Improve Your Business

12 Risked Based Thinking Approach to Pass All Your Audits Concentric ISO ConsultantsHow should manufacturers manage risks on endless challenges to product and process requirements? ISO 9001:2015 is bringing to the overall market; product and service providers, the concept of risk-based thinking / approach with the intention to create the culture of prevention and make it a habit.

Within medical devices, pharmaceutical products, automotive components, and aerospace systems manufacturers there are some product and process requirements which technical acceptance levels are challenging to reach and have been becoming continuously more restrictive for multiple reasons. Some specific examples are the Sterility Assurance Level (SAL) in the medical industries and the Cleanliness Level (CL) in automotive and aerospace. Both requirements are related to contamination.

Different in nature, the medical / pharmaceutical industry deals with biological microorganisms while automotive / aerospace deals with microscopic debris. However, both are very similar from the target standpoint. ZERO is the ideal, unattainable goal; therefore very restrictive acceptance levels are required, standardized, and regulated at the edge of the available knowledge and technology. All around it’s a thousandth fraction of a unit in terms of probability of occurrence or actual mass (ANSI/AAMI ST 67 and ISO/TC 198/WG15 to be released).

Risk management techniques are not new and are standardized by ISO 31000 (General) and ISO 14971 (Application to Medical Devices). So what is the importance of the new concept for risk-based thinking / approach? It is to diligently pursue the more restrictive acceptance levels preparing the way for new products that can make people's life even better. And there is no magic formula other than real, hard work.

The risk-based thinking / approach suggests some "easy to state but difficult to execute" tasks for during a risk assessment:

1. Focus on the intended use of the product.

2. Bring knowledgeable professionals to the assessment (risk assessment itself) and the actual product and actual processes.

3. List of all the known risks to all interested parties: patient, service providers, operators, and estimate the degree of effects.

4. Gather all knowledge about the risks and the likelihood of occurrence.

5. Ensure capable methods of measurement of biological contamination or cleanliness level.

6. Select reliable methods of risk evaluation.

7. Prioritize the risks: rank them according to what is acceptable and what is not.

8. Maximize the availability of suitable manners to eliminate, avoid, reduce or mitigate the risks.

9. Define the validation process for risk mitigation.

10. Ensure comprehensive, detailed, and complete assessments of the designed or implemented manufacturing process. Recognition of the biological and physical limitations for further improvement.

11. Ensure the effectiveness of all actions taken.

12. Ensure there is a robust control plan to sustain the intended process and product performance.

The risk-based thinking / approach is not new to the standards, but in the new ISO Standards revision, it is structured so that it is better incorporated. How is your organization approaching risk assessments? Leave a comment and let us know what best practices you are looking to implement.

If you have any questions or need help in implementing a risk-based approach, Concentric has a solution that will get your organization on the right track to passing your next audit with flying colors.

ISO 9001:2015 Forum - July Webinar Recording is Posted

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO 9001, ISO/TS 16949, AS9100, ISO 14001, ISO 45001 and more). Visit our ISO 9001:2015 Resources page for more webinars and key links to resources.

ISO 9001:2015 June Webinar

Quality Professionals are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum is part of a series of updates from Charleston area subject-matter experts aimed at assisting organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO/TS 16949, AS9100, ISO 27001 and ISO 14001).

3 SEATS LEFT for ISO/TS 16949:2009 Internal Lead Auditor (32hrs)

Folly Beach - Charleston BeachesLast call for our Fall 2014 Automotive Quality Series with our ISO/TS 16949:2009 Lead Internal Auditor Course. We have THREE seats remaining. The courses will be held at the aLoft Charleston Airport & Convention Center. Learn by day. Hit the beach after class. Why not make the most of your professional development? Don't just take a class - experience business differently. Price includes all course materials, parking, wifi, light breakfast, lunch & afternoon snacks. Dozens of food and entertainment options are within blocks from the hotel.

Register & pay online here or by calling 843.469.8279.

Description:   This advanced internal auditing course caters to the full spectrum of auditor responsibilities – from process auditing to audit program management. This course will teach you the fundamental tools necessary to conduct audits using the automotive process approach while providing vital strategic information to top management. Case studies and scenarios make this course fun. If you are looking for a Lead Auditor course for internal processes or supplier quality development, look no further. This course is for you. NEW: We will also discuss the TS Rules 4th Edition and draft of the proposed ISO 9001:2015 standard. Get a jump on what to expect with the changes and it’s potential effect on your management system implementation.

Designed for:  Audit Program Managers, Lead Auditors, Advanced Audit Team Members, Supplier Quality Engineers & Managers, Process Improvement Managers, Quality Directors, Continuous Improvement Managers, Organizational Development Directors, Management Representatives

This course meets or exceeds the training requirements for:

  • Ford Customer-specific Internal Quality Auditor requirements
  • General Motors Customer-specific Internal Quality Auditor requirements

Length:  4 days/32 hours   CEUs:  3.2    A certificate will be given upon successful completion of all course requirements.

The instructor for this course will be Jim Thompson, President of Concentric and Exemplar Global (formerly RABQSA) Accredited QMS Lead Auditor. Register online here, contact us by email at info@cmsicharleston.com or by calling 843.469.8279.

Day 1
▪    Introduction & Welcome
▪    Gathering of Student Goals & Expectations (CSRs)
▪    Overview of ISO 9001 & ISO/TS 16949 – Part I
▪    Selling QMS to Top Management
▪    The Automotive Process Approach
▪    Overview of ISO 9001 & ISO/TS 16949 – Part II
 
Day 2
▪    Use of Turtle Diagrams for Process Mapping
▪    ISO/TS 16949 Requirements – Clause 4.0, Quality Management System
▪    ISO/TS 16949 Requirements – Clause 5.0, Management Responsibility
▪    ISO/TS 16949 Requirements – Clause 6.0, Resource Management
▪    Overview of AIAG Core Tools (APQP & CP, FMEA, MSA, PPAP & SPC)
▪    ISO/TS 16949 Requirements – Clause 7.0, Product Realization
 
Day 3
▪    ISO/TS 16949 Requirements – Clause 7.0, Product Realization
▪    ISO/TS 16949 Requirements – Clause 8.0, Measurement, Analysis & Improvement
▪    Audit Objectives & Auditor Attributes
▪    Process Auditing Breakout
▪    Writing Audit Findings – NCRs & OFIs
 
Day 4
▪    Reporting Audit Findings
▪    CAPA – Corrective Action & Preventive Action
▪    Closing Out Audit Findings
▪    Closing the Audit Cycle
▪    Evaluating Audit Effectiveness
▪    Final Review/Q&A
▪   Student Goals & Expectations (Reviewed)
▪   Course Examination
 
 

Writing a Nonconformance (NCR)

NCR can find broken processes and really help with profit improvement "A problem well stated is a problem half solved." - Charles F. Kettering, American Inventor & Social Philosopher

The first step in solving a problem is to ensure you fully understand what the problem actually is. I regularly see horrible examples of this in practice inside some of the companies I work with. One classic example was in Atlanta, GA a few years ago. Here is the scenario...

Operations Manager: "What the h@!! is going on? Logistics has dropped the ball again! Our #1 line is down because they can't get their heads out of their a$$e$ and keep up with ordering the resin we need. This is our biggest customer!"

The scenario, at least in the mind of the Operations Manager, was that the Jack-Wagons working over in the Logistics Department simply couldn't count. I didn't buy it. In this case, as in most cases where suppositions seem a bit unlikely, I decided to do something I typically do during an audit - walk the audit trail by following the process upstream. This seems like such an obvious move... 1. There's a problem. 2. Walk the trail to find out the source. 3. Ask questions and "show me, show me, show me". HOWEVER, in many organizations, the minute an employee crosses the line into another department he/she is outside of their home turf. A defensive culture will likely breed a departmental approach (staying in your own neighborhood) versus a process approach. If you are not familiar with the process approach, you can learn more about this methodology here from a March 2011 post.

After walking the trail and crossing the territorial boundaries of Production into Scheduling and on to Logistics, I was able to trace back the material in the ERP system with the status "On Hand" and location "Op 120" -  which was the Molding Operations where I had started my hunt. After circling back around to the Operations Manager and hearing another string of Logistics bashing, I started to do some real snooping in the surrounding areas.

Standing at what I'd like to call the base camp of "Mount Unknown Product", I rolled up my sleeves like a eager bidder on Storage Wars and sifted through stacks of components, raw materials and residual miscellaneous. No luck there, although I noted the lack of control and visited that area later in the audit. After asking several questions of several Molding Operators, one of the ladies jumped in with "Oh yeah, that's probably that skid over there in the corner." Sure enough, the skid we were looking for was off in the corner with a simple 2"x2" yellow sticky label on it marked "BAD PRODUCT".

After pointing out to the Operations Manager that the source of the problem was likely one of his team members as opposed to those fools in Logistics, I asked him to consider a better solution. I then pointed out how I would be writing a Nonconformance Report for this finding, and how my nonconformance statement would clearly define the problem at hand. I jokingly stated, "If you want, I can write this NCR in a similar way as that sticky note? I can simply write 'Bad Process' and let you try to remember what I actually meant." He didn't think it was funny.

There were several missing links to the materials and inventory control process I observed during this audit; none that included someone coming to work deliberately trying to screw things up. Links that were obviously broken were the identification of product, controlling suspect or known nonconforming product, use of approved documentation and recording the instance of a nonconformity. An important transactional control was also missing, which was the signal used to notify Logistics that the parts were now unavailable. That signal should have been an ERP move from "Op 120" to "Op 120 Hold". That move to Op 120 Hold would have signaled the Logistics group to order another batch of components in order to keep the customer's order moving forward.

At the end of the day, the use of a simple 1-page Nonconformance Report (NCR) that forces the Originator to follow a simple process checklist (i.e. Yes/No - Did you move product out of IN PROCESS into a PRODUCT HOLD Operations?) may have prevented a late shipment. By the way, the company's poorest performing KPI (key process indicator) was "% On Time Delivery". This KPI was also tied to their variable compensation profit sharing process.

Nonconformance Report (NCR)

Here is an example of a simple NCR Form that may be useful in improving YOUR bonus payout. Click on the image to launch the product and view the PDF or download the native version. Who would have thought a simple form could make your customer and your wallet happier?

Cheers,

Jim Blog Signature

Forum on changes to ISO 9001:2015

Calling all Quality Professionals | Forum on Changes to ISO 9001:2015

Quality Professionals from Charleston, SC and the surrounding region are invited to attend an open forum on expected changes to the ISO 9001:2015 International Standard. This forum will be the first in a series of updates from local subject-matter experts aimed at assisting regional organizations in their preparation of the upgrade to the new standard. The panel of experts will include veterans from various sectors such as automotive, aerospace, environmental and information security to discuss the potential impacts on various industry-specific standards (ISO/TS 16949, AS9100, ISO 27001 and ISO 14001).

Let the voice of your organization be heard

We will also be joined by Denise Robitaille, core member of the United States TAG (Technical Advisory Group) to discuss the latest Committee Draft, global feedback thus far and the next steps in the updating process. Her participation in this forum also allows each participant to voice their questions, comments or recommendation related to proposed changes.

AGENDA
8:30am    Check-in & Networking (Light breakfast buffet included)
9:00am    Introduction
9:15am     Keynote presentation by Denise Robitaille from US TAG
10:00am  Overview of significant changes
10:15am   Industry-specific breakout sessions
11:00am  Participant Voice of Customer (VOC) feedback for US TAG
11:15am   Recommendations for action moving forward
11:30am  Adjourned (end of forum in conference space)
Noon        Lunch discussion with panelists (interested attendees are invited to an open lunch at their own expense in the restaurant)
 
LOCATION
Harbor Breeze (next to Omar Shrine Temple)
176 Patriot's Point Blvd
Mount Pleasant, SC 29464
(843) 606-2110
 

Denise Robitaille HeadshotAbout the Keynote Speaker:  Denise Robitaille is the author of The Corrective Action Handbook and The Management Review Handbook, as well as numerous articles on quality. She is a consultant, writer and trainer.  Denise is also a RAB Certified Lead Assessor and CQA.  Much of her work involves assisting companies implement and maintain ISO 9001 systems.  An international speaker, she has given talks on a variety of quality issues. Denise is a member of the executive committee of ASQ Boston Section and an instructor for the ASQ Boston Education Program. Her work has encompassed companies in a variety of markets, including machine shops, printed circuit board industries, bio-pharmaceutical devices, packaging industry, distributors, navigational instrumentation, and power transmission manufacturing. She holds a Bachelor’s Degree from the University of Massachusetts at Amherst. Eventbrite - ISO 9001:2015 Forum

TSLA August 2013

TWO Sessions August 27-30, 2013  |  Columbus, IN & Charleston, SC

ISO/TS 16949:2009 Internal Lead Auditor Training (32hrs):  $1495*

SummerSpecialThe courses will be held at the new Harbor Breeze on Patriots Point in beautiful Mt. Pleasant, SC (Charleston). Students attending our Indiana course will be catered to by our great friends - who always receive outstanding hospitality reviews - at Tre Bicchieri in downtown Columbus.

Register online here or by calling 843.469.8279.

Description:   This advanced internal auditing course caters to the full spectrum of auditor responsibilities – from process auditing to audit program management. This course will teach you the fundamental tools necessary to conduct audits using the automotive process approach while providing vital strategic information to top management. Case studies and scenarios make this course fun. If you are looking for a Lead Auditor course for internal processes or supplier quality development, look no further. This course is for you. NEW: We will also discuss the CD1 draft of the proposal ISO 9001:2015 standard and it's potential effects on your management system implementation.

Designed for:  Audit Program Managers, Lead Auditors, Advanced Audit Team Members, Supplier Quality Engineers & Managers, Process Improvement Managers, Quality Directors, Continuous Improvement Managers, Organizational Development Directors, Management Representatives

This course meets or exceeds the training requirements for:

  • Ford Customer-specific Internal Quality Auditor requirements
  • General Motors Customer-specific Internal Quality Auditor requirements

Length:  4 days/32 hours   CEUs:  3.2    A certificate will be given upon successful completion of all course requirements.

*Price include training materials and training facilities for each student.  SEND TWO STUDENTS & THE THIRD STUDENT ADMISSION IS FREE!  Promo Codes: 2for3 for multi-student early registration

All of our instructors are accredited with extensive industry expertise in the respective course(s) they teach.  CVs/Resumes can be provided upon request at any time. Register online here, contact us by email at info@cmsicharleston.com or by calling 843.469.8279.

Day 1
▪    Introduction & Welcome
▪    Gathering of Student Goals & Expectations (CSRs)
▪    Overview of ISO 9001 & ISO/TS 16949 – Part I
▪    Selling QMS to Top Management
▪    The Automotive Process Approach
▪    Overview of ISO 9001 & ISO/TS 16949 – Part II
 
Day 2
▪    Use of Turtle Diagrams for Process Mapping
▪    ISO/TS 16949 Requirements – Clause 4.0, Quality Management System
▪    ISO/TS 16949 Requirements – Clause 5.0, Management Responsibility
▪    ISO/TS 16949 Requirements – Clause 6.0, Resource Management
▪    Overview of AIAG Core Tools (APQP & CP, FMEA, MSA, PPAP & SPC)
▪    ISO/TS 16949 Requirements – Clause 7.0, Product Realization
 
Day 3
▪    ISO/TS 16949 Requirements – Clause 7.0, Product Realization
▪    ISO/TS 16949 Requirements – Clause 8.0, Measurement, Analysis & Improvement
▪    Audit Objectives & Auditor Attributes
▪    Process Auditing Breakout
▪    Writing Audit Findings – NCRs & OFIs
 
Day 4
▪    Reporting Audit Findings
▪    CAPA – Corrective Action & Preventive Action
▪    Closing Out Audit Findings
▪    Closing the Audit Cycle
▪    Evaluating Audit Effectiveness
▪    Final Review/Q&A
▪   Student Goals & Expectations (Reviewed)
▪   Course Examination
 

October Course Quickly Approaching

LAST CALL FOR OCTOBER 2011 COURSE

ISO/TS 16949:2009 Internal Lead Auditor Training (32hrs)  |  October 24-27, 2011 - Charleston, SC

Additional course dates:

November 14-17, 2011 - Columbus, IN December 12-15, 2011 - Charleston, SC 

Course Description

Join us at The Tides - Folly Beach, SC.  Bring your family or friends so you can join them for fun in the sun in between classes!  Group rates starting at only $129/night with advanced registration.

This advanced course caters to the full spectrum of ISO 9001 and ISO/TS 16949 auditor responsibilities – from auditing using the most effective automotive process approach to audit program management.  If you are looking for a Lead Auditor course for internal processes or supplier quality development with a focus on the automotive process auditing and use of the AIAG core tools, look no further. This course is for you!

This course will teach you the fundamental tools necessary to conduct audits and provide vital strategic information for SELLING your findings to top management in order to improve organizational objectives. You will also learn the requirements associated with properly addressing nonconformities to prevent recurrence and pro-active techniques for evaluating business risks. Real world tools, case studies and scenarios make this course a challenge, but a lot of fun.

This course meets or exceeds the training requirements for:

  • Ford Customer-specific Internal Quality Auditor requirements
  • General Motors Customer-specific Internal Quality Auditor requirements

Length: 4 days/32 hours CEUs: 3.2 A certificate will be given upon successful completion of all course requirements.

ISO/TS 16949:2009 Internal Lead Auditor Training (32hrs): $1495*

*Price include training materials and training facilities for each student.  SEND TWO STUDENTS & THE THIRD STUDENT ADMISSION IS FREE with our 30-day Pre-Pay Option!   To register, reach us by email at jim.thompson@cmsicharleston.com or by calling 843.469.8279.

All of our instructors are accredited with extensive industry expertise in the respective course(s) they teach. CVs/Resumes can be provided upon request at any time. To register, complete our Course Registration Form, contact us by email at jim.thompson@cmsicharleston.com or by calling 843.469.8279.

Course Agenda

DAY ONE

Title

Start

Finish

Chapter 1 - Course Introduction

8:00

8:30

Interview Exercise

8:30

9:15

Chapter 1.5 – Introduction to ISO / TS 16949 including CSRs

9:15

10:00

Break

10:00

10:15

Team Exercise – Documentation requirements

10:15

10:45

Chapter 2 – The Deming Cycle & 8 QMS Principles

10:45

11:30

Team Exercise – Customer Focus

11:30

12:00

Lunch Break

12:00

1:00

Chapter 3 – Process Approach (includes multiple exercises and role play scenarios)

1:00

4:00

Daily Wrap-up

4:00

4:30

 DAY TWO

Title

Start

Finish

Day 2 Ice Breaker – summarize past day learning

8:00

8:15

Chapter 3.5 – APQP, Control Plan and PPAP

8:15

10:00

Break

10:00

10:15

Team Exercise – PPAP Case Study – Control Plan

10:15

10:45

Chapter 3.5 – APQP, Control Plan and PPAP - continued

10:45

12:00

Lunch break

12:00

1:00

Chapter 4 – Risk and Problem Solving

1:00

2:00

Team Exercise – PPAP Case Study- FMEA

2:00

2:30

Coffee break

2:30

2:45

Chapter 4 – Risk and Problem Solving – continued

2:45

3:15

Team Exercise – Pokayoke

3:15

4:00

Daily Wrap-up

4:00

4:30

DAY THREE

Title

Start

Finish

Day 3 Ice Breaker – summarize past day learning

8:00

8:15

Chapter 5 – Variation -MSA

8:15

9:00

Team Exercise – PPAP Case Study –MSA

9:00

9:30

Coffee Break

 9:30

9:45

Chapter 5 – Variation -SPC

9:45

10:30

Team Exercise – PPAP Case Study –SPC

10:30

11:00

Chapter 6 – Waste and Lean Manufacturing

11:00

12:00

Lunch Break

12:00

1:00

ISO/TS 16949 Quiz

1:00

2:00

Chapter 7 – Audit Trails & Role Play Exercise

2:00

2:30

Coffee break

2:30

2:45

Chapter 8 – Nonconformances and Team Exercise

2:45

4:30

DAY FOUR

Title

Start

Finish

Closing Meeting Role Play – PresentNCRResults

8:00

10:00

Coffee break

10:00

10:15

Chapter 9 – Corrective Actions and Team Exercise

10:15

11:00

Chapter 10 – Audit Reporting

11:00

11:30

Chapter 11 – Audit Program Management

11:30

12:00

Lunch Break

12:00

1:00

Chapter 12 – Approach to the Audit

1:00

1:30

Course Conclusions and Student Feedback

1:30

2:00

Exam

2:00

4:00

 NOTE: All PPAP case study exercises also include instructor led role play scenarios

Click here to launch our Course Registration Form.

Automotive Process Approach

The process approach is taking any activity, or set of activities, that uses resources to transform input to outputs.  For example, every day a restaurant tranforms a certain amount of energy and materials into creating a meal for it's customers.  The output of the process ---> the quality and efficiency of the meal + facility cleanliness + the dining experience + appropriate cost + other expected elements = meeting the desired results of the customers.

The systematic identification and management of the processes employed within an organization, and particularly the interactions between such processes, is referred to as the “process approach”.

Effective operations depend on:

  • identification and management of numerous interrelated processes
  • clear understanding for how processes interact
  • clear expectation of output from one process equals an input into another
  • clear communication of roles and responsibilities
  • an overall understanding of the big pictures (goals & objectives)

The automotive process approach is a requirement from the IATF Rules documents (ref. Rules for Achieving IATF Recognition: 3rd edition for ISO/TS 16949).  Automotive organizations must ensure that priority is given to:

  • questioning processes, the sequence and interactions, and performance against the measures defined
  • focus on processes which directly impact the customer
  • questioning the process objectives/targets, with focus on where targets are not being met
  • focus on issues that have the greatest impact on the customer
  • questioning what plans are in place to ensure targets are met
  • corrective action plans where objectives are not being met
  • following audit trails to linkages between customer concerns, performance against objectives and relevant process documents (e.g. control plan, FMEA, etc.),
  • questioning the clients' process for gathering, communicating and implementing customer-specific requirements

Focus on the customer.  Is the customer satisfied with their dining experience?  How can we do better tomorrow?

Focus on organizational performance.  Did we achieve, as a business, our organizational goals (i.e. make a profit, retain valued staff, satisfy regulatory requirements, etc.)?