Quality & Productivity Solutions, Inc. · Project Management Professional PMP® Certification...

of 10

In this Issue

President’s Welcome Page 1

Risk-based Thinking in ISO

9001: 2015 Page 2

Training Grants Available

through the Workforce

Training Fund Page 6

QPS New Jersey News Page 7

Upcoming Courses Page 8

Training Locations Page 10

President’s Welcome Moving Forward in the New

Economy – Jay P. Patel

As the economy improves, the

demand for a skilled

workforce increases.

Organizations are not only

looking to get the job done,

but they also look to deliver

above and beyond set

expectations. The

development of skills

necessary to achieve this

objective can only be achieved

through rigorous training.

QPS proudly offers training

solutions that focus on the

needs of each organization.

We have a proven track record

of success in the

implementation of Lean Six

Sigma, Project Management,

and other initiatives. As we

move forward in the new

economy, QPS is your partner.

With over 100 courses, QPS

is sure to have a training

solution for your

organization. Whether it be

improvement in product,

service, cost performance or

systems, bottom-line results

are our business. We partner

with our customers to

understand and assess their

needs; developing effective

strategies and solutions that

enhance the total

organization.

Our success is based on the

commitment and promise to

help our clients succeed.

Let‟s succeed together in this

new economy!

Quality & Productivity Solutions, Inc. www.qpsinc.com [email protected] 1-877-987-3801

Experts in Lean Six Sigma, Management Systems, Supply Chain, Project Management & Professional Development

“Organizations are not only looking to get the job

done, but they also look to deliver above and

beyond set expectations.”

April 2015

“A customer is the most

important visitor on our

premises. He is not dependent

on us. We are dependent on

him. He is not an interruption in

our work. He is the purpose of it.

He is not an outsider in our

business. He is part of it. We are

not doing him a favor by serving

him. He is doing us a favor by

giving us an opportunity

to do so.”

– Mahatma Gandhi

of 10

Risk-based Thinking in ISO 9001: 2015 By Jack Reardon

ISO 9001:2015 has taken a different approach to the way in which its requirements are stated, when compared to

the ISO 9001:2008.

To make it really a generic and applicable to all types of organization producing any type of product or services, ISO

9001:2015 aims to:

Harmonize Management System Standards Such as QMS, EMS, En-MS, ISMS, FSMS, ITMS and OHMS

Eliminate Unnecessary Documented Procedures Requirement

Introduce Risk Based Thinking

Introduce Common Text, Common Structure and Common Terms

What is Risk?

Risk management principles are effectively utilized in many areas of business and government including finance,

insurance, occupational safety, public health, pharmaceutical, pharmaco vigilance, and by agencies regulating these

industries.

Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. However,

achieving a shared understanding of the application of risk management among diverse stakeholders is difficult

because each stakeholder might perceive different potential harms, place a different probability on each harm

occurring and attribute different severities to each harm.

International Organization for Standardization (ISO) standards requires organizations to identify and assess threats,

along with their associated risks.

Risk Classification

There are 2 types of risks:

Business risks: A risk of a gain or loss e.g. a product can either gain or lose money

Pure (Insurable) risk: Only a risk of loss Example: Fire, theft, which Can be transferred to another party by

Contracting, Warranty or Insurance.

ALL RISKS

Internal RISKS External RISKS

Mgt. RisksTechnology

RisksCommercial

RisksRegulatory

Risks

of 10

Two primary principles of quality risk management are:

1. The evaluation of the risk to quality should be based on scientific knowledge

2. The level of effort, formality and documentation of the quality risk management process should be

commensurate with the level of risk.

Risk Management Planning

Risk Management planning is the process of deciding how to approach and plan the risk management activities for a

project. It is important to plan for risk management, determine right level, type and visibility of risk, Identify and

validate stakeholders risk thresholds and generate the risk management plan.

Initiating a Quality Risk Management Process

Quality risk management should include systematic processes designed to coordinate, facilitate and improve science-

based decision making with respect to risk.

Possible steps used to initiate and plan a quality risk management process might include the following:

Define the problem and/or risk question, including pertinent assumptions identifying the potential for risk

Assemble background information and/or data on the potential hazard, harm or human health impact relevant

to the risk assessment

Identify a leader and critical resources

Specify a timeline, deliverables, and appropriate level of decision making for the risk management process

Continues on next page…

of 10

Overview of a Typical Quality Risk Management Process

Risk Identification

Risk identification is the process of determining which risks might affect the project and documenting their

characteristics such as:

Locate risks

Display internal and external risk sources

Disclose causes and effects of risks

Involve experts, stakeholders etc.

Risk Control

Risk response planning develops the options and actions to enhance opportunities and reduce threats to project

objectives and Includes identification and assignment of individuals to take responsibility for each agreed upon risk

response.

It uses 4 major response strategies

Avoidance

Transference

Mitigation

Acceptance

Output is a risk response plan


Initiate

Quality Risk Management Process

Risk Identification

Risk Analysis

Risk Evaluation

Risk Reduction

Risk Acceptance

Risk Process Output

Review Events

Unacceptable

Ris

k C

om

mu

nic

atio

nR

isk Ma

nag

emen

t To

ols

of 10

Risk Review

Risk management should be an ongoing part of the quality management process. The output/results of the risk

management process should be reviewed to take into account new knowledge and experience.

Risk monitoring and control keeps track of the identified risks, monitors residual risks, identifies new risks, ensures

execution of risk plans and evaluates effectiveness.

It is advisable to Conducts risk reviews periodically and Identify new risks that might results from changes and

Implement risk response plans if risks occur.

While accepting risk “How much is too much” needs to be specified for each risk. Example: More than 2 working

days delay in installation of X not acceptable. Therefore threshold here is < 2 working days

Benefits of Risk Management

Followings are the salient advantage of having risk management strategy in place:

Protects project objectives

Maximizes results of positive events

Minimizes consequences of adverse events

Minimizes unpleasant surprises

Focus on building right the first time

Proactive not reactive

Author: Jay P. Patel is an ASQ Fellow, Master BB, Lean Expert, PMP, Risk Management Professional with 10 ASQ

Certifications, and many other certifications, for more info or questions, contact [email protected]

of 10

Training Grants are Available through the

Workforce Training Fund!

Improve quality, on-time delivery, and productivity!

Improve business processes!

Reduce cost and waste!

Meet new challenges coming from demanding customer requirements!

Experience company growth!

Increase market share!

Remain competitive

Have you ever wanted your company to experience a Lean Six Sigma or ISO initiative but were

overwhelmed by the costs? If so, this training grant is for you! The Massachusetts Workforce Training

Fund awards up to $250,000 for training per applicant! QPS provides free consultation on training

need assessment and grant writing service at NO CHARGE!

Now is the time to implement

Lean,

Six Sigma

ISO Related

Supply Chain Excellence

Project Management

Performance Excellence

FDA Related, ASQ & APICS Certifications

Management Development

Team Based Initiatives, Strategic Planning

Creativity & Innovation

at your company!

The workforce training fund is “a state fund financed entirely by Massachusetts employers. The purpose

of the fund is to provide applicants with funds to train current and newly hired employees. The fund has

been appropriated a minimum of $18 million each state fiscal year.

Make breakthrough improvements and be more competitive in the market place by

developing robust processes, reducing waste, improving quality and developing

innovative products!

Workforce Training Fund

Benefits

For further details, contact [email protected]

or call toll-free 1-877-987-3801

of 10

QPS New Jersey News

From left to right: Edwin May, Patricia Smith, Jay Patel at ASQ North Jersey section

304 Spring Quality Conference 2015.

QPS New Jersey representatives Edwin May and Patricia Smith attended the ASQ North Jersey section

304 Spring Quality Conference 2015 along with QPS President Jay Patel. Edwin, Patricia, and Jay were

excited to discuss the services QPS has to offer with attendees of the conference.

New Jersey residents also have access to many of the courses QPS offers at its corporate headquarters.

Courses include:

Lean Six Sigma Green Belt

Project Management Professional PMP® Certification Preparation

Risk Management Professional RMP® Certification Preparation

Medical Device Regulations

For more information, please contact New Jersey Director Edwin May at 201-274-6257 or

[email protected].

of 10

Quality & Productivity Solutions, Inc. will begin to offer training in ISO 9001:2015 throughout the

Northeast. Please check our website www.qpsinc.com for the latest information

on courses and dates.

ISO 9001: 2015

Quality Management System

Today‟s organization must exceed industry expectations to succeed in global markets. Businesses

need to comply to increasing regulations and expectations to compete, requiring more focus on

„making it right the first time‟ and cutting costs while doing it. ISO 9001 is a quality standard geared

to providing product and services companies that provides the foundation from which to build that

success.

The Strategy

The ISO 9001 standard is designed to help businesses standardize their quality by providing a

balanced set of core processes that maintain a foundation for management to operate, employees to

perform, and products to be made properly in an efficient and effective manner to achieve customer

satisfaction. This system allows for widespread visibility of problems and offers the ability to

manage those issues at their root, changing processes to continue improved outcomes.

ISO is exactly what is says it is—a standard for doing business. When we plan, we grow, when we

learn, we develop the opportunity to improve, and work smarter. ISO standards set the foundation

for good business and safe business practices. It is a process-based management system and requires

a fair amount of effort by all to implement properly and achieve the desired results.

What ISO 9001 Can Do For You

ISO 9001 has the ability to bring out the best in people, process and performance if designed,

documented and deployed properly. The QPS program provides all the tools needed to design and

implement a system that belongs to you, generating ownership, building an empowered workforce

and produce forward-looking focus. Whether it is a new or established system, we can walk you

through creating or updating a system that improves your business and brings bottom-line success.

Using proven techniques, QPS provides the consulting and training that clients need to understand

what is required to implement the quality system appropriate for your business, acquire registration,

and realize the potential to improve the workplace. Our services give providers the knowledge they

need using a comprehensive method that teaches teams in every function how an ISO 9001 system

can make gains for everyone.


Upcoming Courses: ISO 9001:2015

of 10

We provide specific support in:

Gap Assessment

Implementation Plan Development

Process Based Documentation

Quality Manual & Procedures

Developing Internal auditors and Certifying them

Preparing your Managers & QMS personnel

Organizational Support for Registration

Auditors for Ongoing Audit Support

Our program starts at the beginning, doing a gap analysis to determine how and if the current system

in use can be used or developed, into what is required for registration. QPS will be glad to do all

documentation also. We create a plan with you to meet your needs, keeping resources and staffing in

mind. We provide training to all levels of staff from management to the production line employee,

providing customized materials to the requirements of your business.

The QPS Advantage

Whether it be improvement in product, service, cost performance or systems, bottom-line results are

our business. We partner with our customers to understand and assess their needs; developing

effective strategies and solutions that enhance the total organization. We help manage culture

change, build confidence in the system and support management to make your system a success.

We have proven knowledge and expertise in all Management Systems as well as customized master

plans to achieve and maintain the system registration for your needs, at your pace and at a reasonable

cost to you. QPS has Exemplar and ASQ certified professionals and they have successfully

completed documentation, trained workforces and helped clients achieve first time ISO 9001

registration in less than six months! We guarantee customer satisfaction, including registration at

first attempt.

Contact us today to create the program that works best for your business. Our consultants will

deploy the entire project for you working with your personnel. Where there are multiple sites or

global business units involved, we maintain the schedule and integrity of the project to meet the

target dates and keep costs at a minimum. We have spent 30 years creating systems to better

manage businesses and prepare them to succeed. Contact us to find out how QPS can help you!

of 10

Massachusetts Headquarters 28 Lord Road Suite 205 Marlborough MA 01752

Training locations 1-877-987-3801 [email protected]

*MASSACHUSETTS*

28 Lord Road,

Suite 205,

Marlborough, MA 01752

*NEW JERSEY*

581 Main Street,

Suite 640,

Woodbridge, NJ 07095

*CONNECTICUT*

1224 Mill Street - Building B

East Berlin, CT 06023

*RHODE ISLAND*

249 Roosevelt Avenue,

Suite 203

Pawtucket, RI 02860

Quality & Productivity Solutions, Inc. · Project Management Professional PMP® Certification...

Documents

Transcript of Quality & Productivity Solutions, Inc. · Project Management Professional PMP® Certification...