This document discusses resilient system design and how complex systems can fail. It explains that imagined systems designed on paper differ from real-world systems due to drift over time from random events, weaknesses in design, changes, and normal variation. To improve systems, the document recommends continuously maintaining systems, revealing controls to operators, identifying leverage points, simulating failures, and developing prevention methods. It also provides examples of how these principles can be applied to production, quality, safety, and information systems.
The FDA has their Design Controls in the Code of Federal Regulations Title 21 Part 820.30, then for outside the US, we have ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes, and finally there is ISO 14971 Medical devices — Application of risk management to medical devices.
How can the New Product Development (NPD) process make conforming to these standards into an advantage and accomplish the appropriate Reliability activities in their proper place and sequence to avoid those expensive “loopbacks” (which are really NPD rework)? Can a NPD project steer clear of situations requiring compromise in Reliability to avoid repeating clinical trials or to preserve the project schedule?
Can a company avoid recalls for Reliability issues by knowing what the Reliability will be before product release?
An optimal New Product Development process will be presented that successfully deals with these challenges.
Process and Regulated Processes Software Validation ElementsArta Doci
Medical device manufacturers operate in a competitive marketplace with increasing end-user demands for features and usability and in a highly regulated environment.
Regulatory bodies look for evidence that medical devices are developed under a structured, quality-oriented development process. By following software validation and verification best practices, one can not only increase the likelihood that they will meet their compliance goals, they can also enhance developer productivity.
Many manufactured products can have a significant impact on the well-being of consumers. As such, it stands to reason that stringent requirements and standards be set firmly in place for their manufacture.
The FDA has their Design Controls in the Code of Federal Regulations Title 21 Part 820.30, then for outside the US, we have ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes, and finally there is ISO 14971 Medical devices — Application of risk management to medical devices.
How can the New Product Development (NPD) process make conforming to these standards into an advantage and accomplish the appropriate Reliability activities in their proper place and sequence to avoid those expensive “loopbacks” (which are really NPD rework)? Can a NPD project steer clear of situations requiring compromise in Reliability to avoid repeating clinical trials or to preserve the project schedule?
Can a company avoid recalls for Reliability issues by knowing what the Reliability will be before product release?
An optimal New Product Development process will be presented that successfully deals with these challenges.
Process and Regulated Processes Software Validation ElementsArta Doci
Medical device manufacturers operate in a competitive marketplace with increasing end-user demands for features and usability and in a highly regulated environment.
Regulatory bodies look for evidence that medical devices are developed under a structured, quality-oriented development process. By following software validation and verification best practices, one can not only increase the likelihood that they will meet their compliance goals, they can also enhance developer productivity.
Many manufactured products can have a significant impact on the well-being of consumers. As such, it stands to reason that stringent requirements and standards be set firmly in place for their manufacture.
Risk management in the development of medical devices. This presentation was for a webinar where we discussed the basics of risk management, a general risk management lifecycle, the requirements of certain relevant standards (ISO 14971, IEC 62304, US FDA Title 21 CFR Part 11), and the practical method called HFMEA. The live demonstration shows you how risks can be managed and compliance achieved using the advanced risk management features of codeBeamer ALM, and also demonstrates the use of our (general) FMEA template.
Computer System Validation is not mere testingAnand Rao. C
Computer System Validation is one of the critical activities that assures Product Quality and Patients Safety to meet the ultimate goal of the regulatory agencies across the globe. Most traditional SDLC/ testing approaches is not suitable to deploy applications to regulated companies under GxP environment. One should have high technical skills and very good understanding about GxP, Predicate rules, 21 CFR Part-11, Annex-11, GAMP, ISPE and PIC/S to define a process that delivers reliable and quality software to regulated companies. Well-designed Computer System Validation process will assure Product Quality, Patient Safety, Data Security and Data Integrity and eliminates risk of 483 and warning letters.
Reliability Centered Maintenance for minimizing integrity failure by Bhavesh Shukla at APAC 2015 Process Safety Management Conference 9th March 2015 Singapore.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Testability refers to the design parameter which makes it relatively easy to identify and isolate faults in the system. Testability can be considered to be a subset of maintainability, because fault detection and isolation are important drivers in the maintainability of a system
Risk management in the development of medical devices. This presentation was for a webinar where we discussed the basics of risk management, a general risk management lifecycle, the requirements of certain relevant standards (ISO 14971, IEC 62304, US FDA Title 21 CFR Part 11), and the practical method called HFMEA. The live demonstration shows you how risks can be managed and compliance achieved using the advanced risk management features of codeBeamer ALM, and also demonstrates the use of our (general) FMEA template.
Computer System Validation is not mere testingAnand Rao. C
Computer System Validation is one of the critical activities that assures Product Quality and Patients Safety to meet the ultimate goal of the regulatory agencies across the globe. Most traditional SDLC/ testing approaches is not suitable to deploy applications to regulated companies under GxP environment. One should have high technical skills and very good understanding about GxP, Predicate rules, 21 CFR Part-11, Annex-11, GAMP, ISPE and PIC/S to define a process that delivers reliable and quality software to regulated companies. Well-designed Computer System Validation process will assure Product Quality, Patient Safety, Data Security and Data Integrity and eliminates risk of 483 and warning letters.
Reliability Centered Maintenance for minimizing integrity failure by Bhavesh Shukla at APAC 2015 Process Safety Management Conference 9th March 2015 Singapore.
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Testability refers to the design parameter which makes it relatively easy to identify and isolate faults in the system. Testability can be considered to be a subset of maintainability, because fault detection and isolation are important drivers in the maintainability of a system
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
NetSuite Health Checks provide organizations with a critical tool to assess and optimize the performance and functionality of their NetSuite ERP system. These checks involve a comprehensive evaluation of various aspects of the system, including data accuracy, configuration, security, and compliance with best practices. By conducting regular health checks, businesses can proactively identify and address issues such as data inconsistencies, system bottlenecks, or security vulnerabilities before they escalate into more significant problems. Additionally, these assessments ensure that the NetSuite system aligns with evolving business needs and industry standards. The insights gained from health checks empower organizations to fine-tune their ERP setup, enhance data integrity, and optimize processes, ultimately maximizing the value derived from their NetSuite investment while minimizing operational risks.
Dashboards are useless. Open YouTube if you want to watch something. What benefits could automation of streaming KPI metrics bring to your business, and what pitfalls and concerns are to be expected? From Time Series analysis approach to building distributed streaming data pipeline.
Artificial intelligence (AI) offers new opportunities to radically reinvent the way we do business. This study explores how CEOs and top decision makers around the world are responding to the transformative potential of AI.
The case study discusses the potential of drone delivery and the challenges that need to be addressed before it becomes widespread.
Key takeaways:
Drone delivery is in its early stages: Amazon's trial in the UK demonstrates the potential for faster deliveries, but it's still limited by regulations and technology.
Regulations are a major hurdle: Safety concerns around drone collisions with airplanes and people have led to restrictions on flight height and location.
Other challenges exist: Who will use drone delivery the most? Is it cost-effective compared to traditional delivery trucks?
Discussion questions:
Managerial challenges: Integrating drones requires planning for new infrastructure, training staff, and navigating regulations. There are also marketing and recruitment considerations specific to this technology.
External forces vary by country: Regulations, consumer acceptance, and infrastructure all differ between countries.
Demographics matter: Younger generations might be more receptive to drone delivery, while older populations might have concerns.
Stakeholders for Amazon: Customers, regulators, aviation authorities, and competitors are all stakeholders. Regulators likely hold the greatest influence as they determine the feasibility of drone delivery.
Oprah Winfrey: A Leader in Media, Philanthropy, and Empowerment | CIO Women M...CIOWomenMagazine
This person is none other than Oprah Winfrey, a highly influential figure whose impact extends beyond television. This article will delve into the remarkable life and lasting legacy of Oprah. Her story serves as a reminder of the importance of perseverance, compassion, and firm determination.
The Team Member and Guest Experience - Lead and Take Care of your restaurant team. They are the people closest to and delivering Hospitality to your paying Guests!
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Senior Project and Engineering Leader Jim Smith.pdfJim Smith
I am a Project and Engineering Leader with extensive experience as a Business Operations Leader, Technical Project Manager, Engineering Manager and Operations Experience for Domestic and International companies such as Electrolux, Carrier, and Deutz. I have developed new products using Stage Gate development/MS Project/JIRA, for the pro-duction of Medical Equipment, Large Commercial Refrigeration Systems, Appliances, HVAC, and Diesel engines.
My experience includes:
Managed customized engineered refrigeration system projects with high voltage power panels from quote to ship, coordinating actions between electrical engineering, mechanical design and application engineering, purchasing, production, test, quality assurance and field installation. Managed projects $25k to $1M per project; 4-8 per month. (Hussmann refrigeration)
Successfully developed the $15-20M yearly corporate capital strategy for manufacturing, with the Executive Team and key stakeholders. Created project scope and specifications, business case, ROI, managed project plans with key personnel for nine consumer product manufacturing and distribution sites; to support the company’s strategic sales plan.
Over 15 years of experience managing and developing cost improvement projects with key Stakeholders, site Manufacturing Engineers, Mechanical Engineers, Maintenance, and facility support personnel to optimize pro-duction operations, safety, EHS, and new product development. (BioLab, Deutz, Caire)
Experience working as a Technical Manager developing new products with chemical engineers and packaging engineers to enhance and reduce the cost of retail products. I have led the activities of multiple engineering groups with diverse backgrounds.
Great experience managing the product development of products which utilize complex electrical controls, high voltage power panels, product testing, and commissioning.
Created project scope, business case, ROI for multiple capital projects to support electrotechnical assembly and CPG goods. Identified project cost, risk, success criteria, and performed equipment qualifications. (Carrier, Electrolux, Biolab, Price, Hussmann)
Created detailed projects plans using MS Project, Gant charts in excel, and updated new product development in Jira for stakeholders and project team members including critical path.
Great knowledge of ISO9001, NFPA, OSHA regulations.
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Jim Smith
678-993-7195
jimsmith30024@gmail.com
2. Core Competency Resilient Systems
How do Complex Systems Fail?
There is a gap between the system as imagined and the system as is.
Imagined
System
System
as Is
Drift
Imagined Systems are:
1. Static
2. Deterministic
3. Result of design
development
4. Assumes system
discipline.
As Built Systems are:
1. Stochastic: Driven by random
variables
2. Constantly require maintenance
3. Hard to predict.
Source: Richard Cook
3. Core Competency Resilient Systems
How do Complex Systems Fail?
Why does drift occur?
Imagined
System
Random Events
Weakness in
System Design
System Change
Normal System
Variation
Increased costs
Time pressure
Safety problems
Quality problems
4. Core Competency Resilient Systems
How to improve complex systems
Richard Cook
Resilient System Design Controls
Imagined
System
Random Events
Weakness in
System Design
System Change
Normal System
Variation
1. Create process for
continuous system
maintenance.
2. Reveal system controls
to operators
3. Reveal the leverage in
the system –lift points
4. Simulate failures
5. Create prevention
methods
Source: Richard Cook
Root Causes
5. Core Competency Resilient Systems
Where do we apply Resilient Systems Design?
Production Systems:
Standards, Takt times, Setups, Maintenance, Training, Documents, etc.
Quality Systems:
Process Controls, Measurement Systems, Corrective Actions, Training,
Inspection Systems
Safety Systems:
Machines, Building Systems, Support Systems, Training
Information Systems:
Standards, Product Codes, Schedules, Routing, Customer information
6. Core Competency Resilient Systems
Time for Planning, Quality
Safety, and Information
Time for production
For maximum profit we want to minimize the non-value added
activities --- but they must be executed in a robust way.
When the non-value activities have a failure they cause
rebound problems on production
7. Core Competency Resilient Systems
System is in balance, Time available for production, information, planning, quality and safety
The four support systems have time to prevent production problems and are not causing production
Problems.
Market
force
Market
force
Market forces increase pressure: Time for production squeezes out time for information, Planning
Quality and Safety------ Risks of failures increase
8. Core Competency Resilient Systems
When a system problem occurs it will blowback and erode production time
Increasing costs and affecting customers.
The focus is to create systems that can withstand the pressure and
Still minimize risks.
9. Core Competency Resilient Systems
Random Events will develop and push back against any part of the system.
The system must be able to detect these events quickly and deal with the
Problems before they get out of hand.
10. Core Competency Resilient Systems
System Design Characteristics System Tools to accomplish Design
and to control processes
Create process for continuous
maintenance of the system.
Regular system audits.
Production system, quality system, safety
system and information system
Reveal System Controls to operators Train all employees
Audits, Corrective Actions, Process
Controls, FMEA’s, Variation reduction
Leverage the system
Identify the lift points
Ask the question– where is the leverage in
out systems. Focus on ongoing variation
reduction
Simulate failures Regular tests of the system.
Design and implement failure tests.
Fire drills, first aid response drills, gage
failure drills, machine failure drills
Develop a prevention system Apply QS APQP
New product process review
Control plans, FMEAs, MSA, Process
Controls, SPC, Pre-Control, Variation
Reduction
11. Core Competency Resilient Systems
Four causes of drift in systems.
1. Weak systems design
2. Changes to the system
3. Normal variation in systems
4. Random variables.
What are some examples of actual activities that we can us to
address these problems.
12. Core Competency Resilient Systems
Weak System Design
In most factories some systems will be stronger than others.
Production is usually the strongest with safety the weakest.
Production System: Audit the system to TS standards, are there control plans, are
they being followed. Work instructions, training records, PM records, scheduling
systems
Quality System: Use the ISO, TS or AS audits. Are they being done regularly.
Procedures, work instructions, training records.
Safety System: Is there a safety system. Are OSHA audits done regularly. Are
there written procedures, work instructions, training records, are there
ongoing open safety problems.
Information system: Audit critical routers, are they correct? Is the coding correct.
13. Core Competency Resilient Systems
System Change
In a strong system there will be a process to introduce new materials, new
parts, new machines, new processes.
Production System: There should be something that aligns with a QS APQP
system for introducing new products. Is there a process and is it being
followed.
Quality System: Are all the documents required to support new products in
place? New measurement systems, new process controls, etc.
Safety Systems: Are new machines and processes reviewed for safety and
hazardous material issues? Is this documented.
Information Systems: Is the information system adjusted for the new
information? Is this change part of the APQP process?? Is it documented
and reviewed. Is it tested?
14. Core Competency Resilient Systems
Normal Variation
Variation occurs in every process. In some cases we have data to
document it and in some cases we not. Our goal is to reduce the variation in
our processes all the time.
Production System: Do we know the amount of variation in our machines,
our standards, our cycle times, our setup times. We need to be
improving these all the time.
Quality Systems: Do we have the skills to reduce our variation? Do we have
the data from all of our processes?
Safety Systems: Need to gather data from our safety systems to begin to see
variation.
Information Systems: Need to gather data from our information systems to
begin to see the variation in our system.
15. Core Competency Resilient Systems
Random Events that affect our system
Random events can cause significant disruption. How we deal with them
will make our system stronger.
There are two key elements that help address random events in the system.
1. Ongoing monitoring of the system that reveals changes in the system and
the active measurement of system drift. This can be through SPC, audit
results or other active methods.
2. The active participation of trained operators who understand the monitoring
that they are doing. People need to be trained to react to random events
and to notify other people to get help to deal with them immediately.
16. Core Competency Resilient Systems
Measuring Drift
Managers should want to know how much their system as drifted from the
original design.
Monitoring this drift reveals a lot about the risk inherent in the business at any
point in time.
There are four key elements supporting production.
Quality, Safety, Planning and Information --- failure in any one of these
will rebound back on production.
Resilient systems theory tells us that any system is subject to the four key
problems. Random events, normal variation, poor system design or changes
in the system.
17. Core Competency Resilient Systems
Measuring Drift
The economics of monitoring
Monitoring the value added portion of the factory is most
important to generating cash flow.
The production system and the factory output get the most attention.
The primary metric is the standard costs income statement supplemented
by daily KPI and cash flow.
The non-value added portions need just enough resources to
insure that production is not affected by system failures.
There are institutional requirements such as ISO, TS and AS systems that
require auditing to meet standard requirements.
There are OSHA requirements that require regular activities and should
lead to regular audits
.
18. Core Competency Resilient Systems
Four separate audits are conducted
on an ongoing basis and then presented at random
to management for review.
19. Core Competency Resilient Systems
Alternative method to reduce costs of audits and to improve direct reporting of
drift.
Audit the plant by key product lines starting with the largest and progressing to
the smallest.
( Review existing ISO and Safety audits– separate work cell specific
material from plant wide material)
Create one audit that integrates Quality, Safety, Information and Planning into
one audit.
20. Core Competency Resilient Systems
Resilient Value Stream Audit
Production: Takt time to output, work
standards, setup time, PM, 5S, training
records
Quality: SPC, Gage R&R, Cpk of
output, training records, Process
controls, corrective actions on key parts.
Information: Router accuracy,
standards, product coding review,
Raw material review, prior approvals.
Planning: Cycle times, on time delivery
Safety: Lockout, machine guarding,
ergonomics, noise, PPE, electrical,
training
21. Core Competency Resilient Systems
How do Systems Fail?
Resources:
How Complex Systems Fail: Richard Cook Univ. of Chicago
Resilience Engineering: Erik Hollnagel, David Woods, Nancy
Leveson
A New Accident Model for Engineering Safer Systems
Nancy Leveson, MIT