ASQ- CQA/ CQOEM/CSSGB September 17, 2015...

Chaitanya Baliga ASQ- CQA/ CQOEM/CSSGB

September 17, 2015

ASQ –Hamilton Section 403 Meeting

Why risk based?

What does it mean?

Where does it lead?

How is it done?

Agenda

Chaitanya Baliga - ASQ Hamilton Sept 17 2015 2

Definitions Harm - physical injury or damage to the health of

people, or damage to property or the environment [ISO/IEC Guide 51:1999, definition 3.1]

Hazard - potential source of harm [ISO/IEC Guide 51:1999, definition 3.5]

Risk - combination of the probability of occurrence of harm and the severity of that harm

[ISO/IEC Guide 51:1999, definition 3.2]

Residual risk - risk remaining after protective measures have been taken.

[ISO/IEC Guide 51:1999, definition 3.9]


Supply Chain

Product or Services


Risk Management

Outsourcing / Supplier Communications Customer Service Facility Management Finance Human Resources Information Technology Inventory Sales / Marketing Production / Manufacturing Distribution

Shipping/Receiving/Transportation/Warehousing Training


External Impact

Geopolitical “Stability” of nations that supply energy

Increasing attention being paid to energy security. Regional Organizations Standards and Regulations

Global Financial Constraints Europe's debt crisis, Fiscal cliff in the U.S. Deceleration of the Chinese economy. South China Sea: disputed maritime borders Other regions:

Argentina / Bolivia, Burma, Egypt, Korea, Malaysia, Mexico, Pakistan, Russia, Syria, Thailand, Turkey and Venezuela.


Regional Organizations

Source: Wikipedia


Intellectual Property Crime in Canada

Increase from 11.5% in 2005 to 30.4% in 2012.

In 2012, over 200 cases of harmful counterfeit products were investigated, including commodities such as toys, pharmaceuticals, perfume, integrated circuits, makeup, headphones, wheel bearings, cellular phones, and batteries.

See more at: http://cacn.ca/health-and-safety/#sthash.K4uzBY2p.dpuf


Intellectual Property Crime in Canada


Product Percentage (retail value)

Apparel and Footwear 45%

Copyrighted Works 20%

Consumer Electronics 9%

Personal Care Products 9%

Pharmaceuticals 6%

Toys 4%

Electrical Products 3%

IP-infringing goods seized in Canada in 2012, where the origin was identified by the RCMP, China (including Hong Kong SAR China) remains the primary source country. Other source countries for counterfeit goods seized in 2012 were India, Pakistan, the United-States and Thailand.

Inherent Technology Complexity Manufacturing capabilities.

Inability to manufacture to the required specifications and volumes

Sufficient understanding of manufacturing processes

Workforce competence

Adopting to new manufacturing technologies

Manufacture more complex components than ones produced before


Imposed Challenges Regulatory demands continue to increase

Regulatory agencies increasing the expectations placed on pharmaceutical , medical device, nuclear, and aerospace companies in managing their suppliers.

Increased number of supplier related recalls and field corrective actions

Robust Quality System or Right Key Performance Indicators (KPIs) Covering the entire value chain.

Void of data-driven root cause/problem solving based on those KPIs


Business Constraints


Complexity

• Globalization

• Regulatory Expectations

• Technology / Processing

• Market Risk /Uncertainty

Sustainability Cost • Documentation • Projects • Systems Interfaces

External • Best Practice/ Compliance • Public / Community • Governments Regulators • Investors / Creditors

Supplier Risk Management

13 Chaitanya Baliga - ASQ Hamilton Sept 17 2015

Counter Measures


Complexity

• Convert data into knowledge

• Fact based decision making

Sustainability Cost • Communication through

sharing best practice and fact based business culture

External • Build trust and

understanding • Proactive Action

Plans

Supplier Management

Proc

ess

Paradigm Shift


Risk Review

R i s

k C

o m m

u n i c

a t i o

n

Risk Assessment

Risk Evaluation unacceptable

Risk Control

Risk Analysis

Risk Reduction

Risk Identification

Review Events

Risk Acceptance

Initiate Quality Risk Management Process

Output / Result of the Quality Risk Management Process

R i s k M

a n a g e m e n t t o o l s

Risk Assessment Process Ref: ICH Q9/ ISO 13000 / ISO14971


Risk Evaluation

The purpose of risk evaluation is to assist in making decisions, based on the outcomes of risk analysis, about which risks need treatment and the priority for treatment implementation.


Strengths Weaknesses Opportunities Threats (SWOT) and Political Economic Social Technological Legal Environmental (PESTLE) analyses offer structured approaches to risk recognition.

Risks and opportunities ISO 9001:2015

A vital part of the planning and implementation of a QMS is a new requirement to identify the risks and opportunities that can potentially impact the operation and performance of the QMS, as well as the corresponding ‘proportionate’ actions to address them.


Probability Detectability Severity

past today future

Refers to

time

Refers to

Refers to

= Risk Priority Number

x x

Product /Process Risk Evaluation FMEA : Process /Design


Severity and Probability Risk

20

Increasing Severity of Harm/Consequence

Incr

easi

ng P

roba

bilit

y of

O

ccur

renc

e

Low

Risk

Medium

Risk

High Risk

Past

Occu

rren

ce

Future Harm/Consequence

Chaitanya Baliga - ASQ Hamilton Sept 17 2015

21

Risk to Quality

Probability Severity

HARM Failure to meet

Needs/Expectations

Quality Attributes

Loss of Quality

Probability/Severity

of Adverse Impact on

Quality Attributes


Product and Process Review


Product : - Identify Critical Variables and Attributes

- Product Design

- Raw Materials

- Assemblies/Kits/Sub-assemblies

- Finished Product

Process :- Identify Critical Process Parameters

- Verification and Validation Requirements

- Process Controls / Reliability / Capability

- Lean

Supplier Management

Proc

ess

Paradigm Shift


Product Risk Level

Supplier Risk Level

Product Risk Level

Material Criticality

Product Recalls

Reliability Data

Process ----

Facility ----


Process Risk Level

Supplier Risk Level

Product Risk ---

Process Risk

Inherent Process Risk Factors

Critical Process Parameters and Controls

Process Controls and Risk Mitigating Factors

Product or environmental contamination

Facility Risk ----


Facility Review


- Quality System

-Regulatory Compliance status -Past and current compliance rating and /or issues -History of inspection/ audits / accreditations

-Estimated volume of production output -Type of establishment

Facility Risk Level

Supplier Risk Level

Product Risk ---

Process Risk -------

Facility Risk

History of Compliance Deficiencies / SCAR’s

History of Inspection / Audits

Production Output / Volume

Type of Establishment

Product Mix


Threats (Natural/Human-Caused): Identify threats that impact critical functions. Civil disturbance • Communications Failure • Earthquake • Explosion • Fire Flood and Flash flood Hazardous Materials Incident • Hurricane • Loss of Key Supplier or Customer • Severe Winter Storm • Technological Emergency • Terrorist Attack • Tornado


Supplier Risk Level

Product Risk

Process Risk

Facility Risk

Supplier Risk


Source: basic model adapted from FDA (1999). Managing the Risks from Medical Product Use.

Known Side Effects

Avoidable Unavoidable

Medication or Device Error

Product Defects

Preventable Adverse Events

Injury or Death

Unexpected Consequences

Public Health

Safety

Efficacy Quality

Managing the risk of drug product use


Product /Materials Risk


Qualitative Risk Estimation in Pharmaceutical /Medical Device

Industry

Healthcare

Severity Scale

Probability of Occurrence

Very

Low Low Medium High

Very

High

Death Medium Medium High High High

Hospitalization Low Medium Medium High High

Acute Illness Low Medium Medium High High

Worry Low Low Low Medium Medium

32

Low

Risk

Medium

Risk

High Risk A B

C


Risk Ranking of Suppliers

33

Process

Facility

Product

1. Supplier M

2. Supplier T

3. Supplier C

4. Supplier D

5. Supplier X

6. Supplier A

Scored and Prioritized

Under Multiple Criteria

(Risk Ranking)


Risk Assessment To define Suppliers Evaluation / Re-evaluation

Risk Analysis oriented to Suppliers classification into criticality classes related to production processes, product and facility

Assess risks across the supply chain

High efficiency and capacity utilization

Regulatory decisions focused on product and process quality


Why risk based? – Business Continuity

What does it mean? – Efficiency/ Cost reduction

Where does it lead? – Effective Supply Chain

How is it done? –Product, Process, and Facility Risk Evaluation

Conclusions


Thank You


References: RISK-BASED METHOD FOR PRIORITIZING CGMP INSPECTIONS

(September 2004)

Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical Manufacturing Sites — A Pilot Risk Ranking Model, ICH 9

http://cacn.ca/health-and-safety/#sthash.K4uzBY2p.dpuf


ASQ- CQA/ CQOEM/CSSGB September 17, 2015...

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