Eng. M. Pasqualini – QMS Italia S.r.l. Managing Director

Quality, Environmental, Health & Safety Certified Auditor

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October 2014 - Moskow

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YOUR CERTIFICATION BODY

RISK MANAGEMENT

FAILURE MODE EFFECT ANALISYS

AS A TOOL FOR A BETTER

“QUALITY OF LIFE”

QMS ITALIA and QMSCERT PRESENTATION

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YOUR CERTIFICATION BODY

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QMS ITALIA is the exclusive partner in Italy and other countries of QMSCERT (Inspection and Certification Body) for the activities of inspection and certification according to international standards and EU directives. Certificates issued by QMSCERT, through QMS ITALIA, are ESYD accredited (Greek Accreditation Body), part of the international agreements of mutual recognition between accreditation bodies (MLA) and then completely valid worldwide.

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QMS ITALIA and QMSCERT YOUR CERTIFICATION BODY

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QMS ITALIA and QMSCERT YOUR CERTIFICATION BODY

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QMSCERT is ESYD accredited against ISO

17021 (as Certification Body) and ISO 17065 (as

Inspection Body) and we have more than

6.000 clients worldwide certified!!

Croatia & Balkans, Albania & Kosovo, Romania, Russian Fed. Ukraine, Lithuania, Uzbekistan & Central Asia, Iran & Middle Est

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QMS ITALIA WORLDWIDE OFFICES YOUR CERTIFICATION BODY

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AND WE ARE IN ONGOING EXPANSION!!!

QMS ITALIA, through QMSCERT, is able to provide to all organizations the following

certification services: - ISO 9001:2008 (Quality MS)

- ISO 14001:2004 (Environment MS) - OHSAS 18001:2007 (Health & Safety MS)

- ISO 22000:2005 (Food Safety MS) - ISO 50001:2011 (Energy MS)

- ISO 27001:2012 (ICT MS)

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QMS ITALIA and QMSCERT YOUR CERTIFICATION BODY

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We are able to provide to all organizations the following certification services on: - ISO 29001 – Oil, Gas and Petrolchemical - ISO 10854 - HACCP System - ISO 28000 - Supply Chain - ISO 31000 – Risk Management - ISO 55001 - Asset Management - Etc…

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QMS ITALIA and QMSCERT YOUR CERTIFICATION BODY

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We are able to provide to all organizations the following

certification services on End of Waste Regulation

- EU Regulation 333:2011 (iron) - EU Regulation 715:2013 (copper) - EU Regulation 1179:2013 (glass)

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QMS ITALIA and QMSCERT YOUR CERTIFICATION BODY

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We are able to provide to all organizations the following product inspection services for: - EU regulation 92/42 on Hot Water Boilers - EU regulation 95/16 on Lifts - EU regulation 97/23 on Pressure Equipment - EU regulation 2006/42 on Machinery - EU regulation 2009/105 on Simple Pressure Vessels

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QMS ITALIA and QMSCERT YOUR CERTIFICATION BODY

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We are also able to provide to all organizations the following product inspection services for: - EU Regulation 305/2011 – on aggregates, bituminous mixtures and asphalts - EU Regulation 834/2007 and EU Regulation 889/2008 on organic products

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QMS ITALIA and QMSCERT YOUR CERTIFICATION BODY

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We are also able to provide to all organizations the following product certification services for: - IFS -BRC - Globalgap

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QMS ITALIA and QMSCERT YOUR CERTIFICATION BODY

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We are able to provide training courses with specific requirements for audit on Management Systems for Quality (ISO 9001), Environment (ISO 14001), Health & Safety (OHSAS 18001), Food Safety (ISO 22000), Energy (ISO 50001), etc. according to ISO 19011:2012 for internal and external auditors accredited.

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QMS ITALIA and QMSCERT YOUR CERTIFICATION BODY

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YOUR CERTIFICATION BODY

Risk management is the identification, assessment, and prioritization of risks (defined in ISO 31000 as “the effect of uncertainty on objectives”) followed by coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events or to maximize the realization of opportunities.

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RISK MANAGEMENT YOUR CERTIFICATION BODY

Several risk management standards have been developed including the National Institute of Standards and Technology and ISO standards. Methods, definitions and goals vary widely according to whether the risk management method is in the context of project management, security, engineering, industrial processes, financial portfolios, actuarial assessments, or public health and safety.

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RISK MANAGEMENT YOUR CERTIFICATION BODY

Risks can come from uncertainty in financial markets, threats from project failures (at any phase in design, development, production, or sustainment life-cycles), legal liabilities, credit risk, accidents, natural causes and disasters as well as deliberate attack from an adversary, or events of uncertain or unpredictable root-cause.

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RISK MANAGEMENT YOUR CERTIFICATION BODY

In ideal risk management, a prioritization process is followed whereby the risks with the greatest loss (or impact) and the greatest probability of occurring are handled first, and risks with lower probability of occurrence and lower loss are handled in descending order.

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RISK MANAGEMENT YOUR CERTIFICATION BODY

For the most part, these methods consist of the following elements, performed, more or less, in the following order:

identify, characterize threats assess the vulnerability of critical assets to specific threats determine the risk (i.e. the expected likelihood and

consequences of specific types of attacks on specific assets)

identify ways to reduce those risks prioritize risk reduction measures based on a strategy.

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RISK MANAGEMENT YOUR CERTIFICATION BODY

The International Organization for Standardization (ISO) identifies the following principles of risk management. Risk management should:

create value – resources expended to mitigate risk should be less than the consequence of inaction, or (as in value engineering), the gain should exceed the pain

be an integral part of organizational processes be part of decision making process

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RISK MANAGEMENT YOUR CERTIFICATION BODY

explicitly address uncertainty and assumptions be systematic and structured process be based on the best available information be tailorable take human factors into account be inclusive be dynamic, iterative and responsive to change be capable of continual improvement and enhancement be continually or periodically re-assessed

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RISK MANAGEMENT YOUR CERTIFICATION BODY

According to ISO 31000 standard "Risk management – Principles and guidelines on implementation," the process of risk management consists of several steps as follows:

identification of risk in a selected domain of interest planning the remainder of the process mapping out the following: ◦ the social scope of risk management ◦ the identity and objectives of stakeholders ◦ the basis upon which risks will be evaluated

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RISK MANAGEMENT YOUR CERTIFICATION BODY

defining a framework for the activity and an agenda for identification

developing an analysis of risks involved in the process

mitigation or solution of risks using available technological, human and organizational resources.

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RISK MANAGEMENT YOUR CERTIFICATION BODY

The management of risks for medical devices is described by the International Organization for Standardization (ISO) in ISO 14971

For the oil and gas industry, hazard identification and risk assessment tools and techniques are described in the international standard ISO 17776 23

RISK MANAGEMENT YOUR CERTIFICATION BODY

After establishing the context, the next step in the process of managing risk is to identify potential risks. Risks are about events that, when triggered, cause problems or benefits. Hence, risk identification can start with the source of our problems and those of our competitors (benefit), or with the problem itself.

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RISK MANAGEMENT YOUR CERTIFICATION BODY

Once risks have been identified, they must then be assessed as to their potential severity of impact (generally a negative impact, such as damage or loss) and to the probability of occurrence.

These quantities, in the assessment process it is critical to make the best educated decisions in order to properly prioritize the implementation of the risk management plan. 25

RISK MANAGEMENT YOUR CERTIFICATION BODY

Typical risk analysis and evaluation techniques adopted by the medical device industry include hazard analysis, fault tree analysis (FTA), failure mode and effect analysis (FMEA), hazard and operability study (HAZOP), and risk traceability analysis for ensuring risk controls are implemented and effective

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RISK MANAGEMENT YOUR CERTIFICATION BODY

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Clinical Risk Analysis with Failure Mode and Effect Analysis (FMEA)

model in an Emodialysis Unit

An application in Italy

YOUR CERTIFICATION BODY

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YOUR CERTIFICATION BODY

HEALTH SITUATON IN ITALY

One of the OECD Better Life Index is “HEALTH”. Italy index in 2013 was 7.8 Total health spending accounted for 9.2% of

GDP in Italy, slightly below the average of 9.4% in OECD countries.

Italy also ranks below the OECD average in terms of total health spending per person, at 3012 USD compared with an OECD average of 3322 USD.

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OECD Health Index YOUR CERTIFICATION BODY

So, when asked, “How is your health in general?” 65% of people in Italy reported to be in good health, below the OECD average of 69%.

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OECD Health Index YOUR CERTIFICATION BODY

So a good health is one of the most important things to people and also brings many other benefits, including enhanced access to education and the job market, an increase in productivity and wealth, reduced health care costs, good social relations, and of course, a longer life.

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To have a “Good Health” means…. YOUR CERTIFICATION BODY

The Council of Ministers approved on 11th May 2007, a Law on "Measures for the safety of health facilities and clinical risk management”

In Italy, before this law, a third of all admissions is represented by the volume of surgery activity preventable.

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What in Italy…. YOUR CERTIFICATION BODY

The studies report an incidence of adverse events associated with surgical procedures performed on patients hospitalized between 3% and 16% with a mortality rate of between 0.4% and 0.8%, and almost half of these adverse events are considered.

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What in Italy…. YOUR CERTIFICATION BODY

After this studies of adverse events, Healh Ministry involved health care organizations in providing annual proactive analysis as risk prevention proposed Healthcare FMEA (HFMEA) as a tool to apply to health care activities.

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What in Italy…. YOUR CERTIFICATION BODY

In 2008 reports of suspected medical errors reached - 2% than the previous year.

The alleged error would occur mainly during a surgery (53% of reports on malpractice) and only in 26% of cases at the time emission of diagnosis, and 12% of the cases for the wrong therapy and 35 errors reported to occur in the rehabilitation phase….

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What in Italy…. YOUR CERTIFICATION BODY

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YOUR CERTIFICATION BODY

HFMEA APPLICATION IN A HEMODIALYSIS UNIT

The aim of clinical risk management is to improve the quality of care provided by health care organizations and to assure patients’ safety.

Failure mode and effect analysis (FMEA) is a tool employed for clinical risk reduction. We applied FMEA to chronic hemodialysis outpatients.

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Background YOUR CERTIFICATION BODY

(i) Process study: we recorded phases and activities.

(ii) Hazard analysis: we listed activity- related failure modes and their effects; described control measures; assigned severity, occurrence and detection scores for each failure mode and calculated the risk priority numbers (RPNs) by multiplying the 3 scores. Total RPN is calculated by adding single failure mode RPN.

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Methods – HFMEA Steps YOUR CERTIFICATION BODY

(iii) Planning: we performed a RPNs prioritization on a priority matrix taking into account the 3 scores, and we analyzed failure modes causes, made recommendations and planned new control measures.

(iv) Monitoring: after failure mode elimination or reduction, we compared the resulting RPN with the previous one.

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Methods – HFMEA Steps YOUR CERTIFICATION BODY

Identification of clinical problems and laboratory tests or advice regarding prescriptions may be inadequate.

The cause of this is that the monthly scheduled medical examination is not well organized and planned

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HFMEA - Results YOUR CERTIFICATION BODY

We found evidence for the importance of a nurse being present during visits, as well as planning and organizing inadequacies.

We reorganized the handling of nephrological examinations, and we changed both medical and nursing organization.

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Results YOUR CERTIFICATION BODY

An audit performed 2 months later showed an increased satisfaction with visit planning from baseline 15.4% to 100%, which was confirmed at 10 months.

Satisfaction regarding interruptions during medical examination rose from 7.7% to 47.7% at 2 months and to 80% at 10 months.

Activity overlap was still a problem; in fact the applied changes do not increase satisfaction enough (from 7.7% to 53% at 10 months). 42

Results YOUR CERTIFICATION BODY

Visit time was assured and optimized, interruptions were reduced, nurses actively participated, planning failures showed a significant reduction, RPN values decreased from 27 to 6 (O score from 3 to 2 and D score from 2 to 1).

Total RPN value decreased from 892 to 815 (8.6%) after reorganization.

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Results YOUR CERTIFICATION BODY

Employing FMEA we focused on a few critical activities to be ameliorated, and we improved processes and introduced some safety procedures, thus reducing the clinical risk index value.

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Conclusions YOUR CERTIFICATION BODY

These changes are cost-free, because of better usage of operators’ time.

Thanks to FMEA, patients’ documentation is updated and made easily available, and nephrological examinations are regularly performed as planned.

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Conclusions YOUR CERTIFICATION BODY

In all of the FMEA we performed, the reduction of total RPN resulted in a great improvement in the service to patients we provide.

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Conclusions YOUR CERTIFICATION BODY

Our failure modes with the highest RPNs came from communication and organization problems.

In 2010 Italian Health Ministry also identified poor communication as a common cause of error in medicine.

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Conclusions YOUR CERTIFICATION BODY

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YOUR CERTIFICATION BODY