Embedding Risk Management Into Your QMS

EMBEDDING RISK MANAGEMENT

INTO YOUR

QUALITY MANAGEMENT SYSTEM

A LESSON FROM THE FOOD INDUSTRY

Selene Crosby

Texas Manufacturing Assistance Center

Southwest Research Institute

www.tmac.swri.org

Texas Manufacturing Assistance Center 1

W HAT I S A

QUALI TY M ANAGEM ENT SYSTEM ?

A system of processes (best practices) that are designed to

produce quality in an end product or service.

Quality is defined as a product that meets customer

specifications.

Customer specifications are broadening to include

sustainability, transparency and continuous improvement.

ISO 9000 is the most well known QMS but there are many others

– tailored to the needs of customers in most product sectors

(aerospace, automobile, electronics, food manufacturing) and

service areas (health care, law, food service)


WHAT IS

RISK MANAGEMENT?

The continuing process to identify, analyze,

evaluate, control, minimize or eliminate unacceptable

risk.

Risk can be categorized in multiple ways, such as

financial, operational, external, people, regulatory,

governance or strategic.


TOOLS YOU ALREADY USE

Quality:

QMS Reviews

GMP – Good Manufacturing Practices

SPC – Statistical Process Control

FMEA – Failure Mode and Effects Analysis

VSM – Value Stream Mapping

Risk Management:

HACCP – Hazard Analysis and Critical Control

Points (Food)

Likelihood/Impact Matrices

Preventative Actions


AN APPROACH TO I NTEGRATI ON:

SQF CASE STUDY

The food manufacturing industry deals with low margins,

perishable inventory and high impact risks like food safety

incidents and recalls, high employee turnover and high need for

regulatory compliance

SQF – Safe Quality Food – is a QMS for the food industry that

takes the HACCP approach to risk management and combines

with FMEA to build an integrated Quality and Safety Management

Plan

See the article in Food Safety Magazine for the full case study

(reference on final slide)


Team Based

Approach

Customer

Requirements Value

Stream

Mapping

Go and See

List modes

of failure

SPCCorrective

Action

Records

Control

I N T E G R AT E D B E S T P R AC T I C E S


A SYSTEMATIC APPROACH:

Like the best quality management systems, we start

with customer requirements and a methodical approach

Like the best process improvement methodologies, we

start with the experience and diversity of a committed

team and a thorough understanding of our process

Like the best risk management systems, we identify and

characterize ALL the risks in our process

Like all of the above, we determine the best way to

control the process (thereby preventing the risks) and the

best way to monitor that the process is in control


FOCUSED, MINDFUL PROCESS

REVIEW:

A process flow is created and each step in the

process (as well as transitions between steps) is

analyzed for quality risks

All risks are captured – likelihood and impact

will be determined later


UTILIZE EXPERIENCE TO BUILD

YOUR TOOLS:

The likelihood and impact matrix should be

built based on your experience with your process

risks

The organization will decide to accept risks

below a certain risk score (likelihood x impact)

Above a certain score, a process to PREVENT

the risk must be put in place


INTEGRATE ACTIONS INTO

YOUR QMS PROCEDURES:

“Critical Quality Points” will be well defined

and corrective actions will be triggered when the

process is out of control

“Critical Quality Points” will be monitored and

records will be required records

Uncontrolled risks are captured and

acknowledged as uncontrolled


TIPS FOR SUCCESS:

The process isn’t difficult, but requires being mindful and

consistent

This approach can work for any process, manufacturing or

other

Don’t neglect the inputs to your process – suppliers, internal

organizations, etc.

Subject your system to a periodic review with the right

people in the room

Understand risk in terms of likelihood and impact – there are

studies that provide ROI on projects for risk avoidance


GOOD LUCK!

Resources:

Steven Atkins, MBA and Marcia Hagen, PhD, “An Integrated

Approach to Food Quality and Safety: A Case Study in the

Cookie Industry”, Food Safety Magazine, April/May 2012

“Implementing an SQF System”, SQF Institute, 2012


Business

Embedding Risk Management Into Your QMS