Do You Know How to Identify Root Cause and How to Close Out Your Investigation?

Getting the Root Cause Analysis (RCA) right is at the soul of the implementation of an effective Corrective and Preventive Action (CAPA) program.

Root Cause Analysis3

Getting the Root Cause Analysis (RCA) right is at the soul of the implementation of an effective Corrective and Preventive Action (CAPA) program. Root Cause Analysis and CAPA are tied to each other intricately. This being the case, it is commonsensical to perform the two functions in tandem with each other applying the principles of risk management. This method makes business sense, as it saves time and cost. This requires companies that want to do an RCA in conjunction with CAPA to have complete knowledge of the principles of CAPA.

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The lack of effectiveness of a company’s RCA is reflected in the inability of the CAPA to fulfill its purpose. An effective Quality Management System is unthinkable without CAPA. In the FDA’s thinking, a Quality System can go awry if effective CAPA is not in place.

So, a CAPA action plan rests on a sound Root Cause Analysis. Any organization that fails to implement this can expect recurring problems and issues. Some of them could turn out to be serious enough to derail their business.

Complete understanding of RCA and CAPA

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All the learning Areas:

  • Regulatory Expectations for Investigations
  • What is RCA and Typical Problems
  • Investigation Process Overview
  • Skills and Tools of an Effective Investigator
  • (Re) Introduction to Root Cause Analysis (RCA)
  • Principles of root cause analysis
  • Why root cause analysis is difficult
  • Methodology of root cause analysis

STEP 1 – Problem Definition

  • How to ensure that the right problem is being worked on
  • Tools and filters for priority setting
  • Developing a clear and sufficient problem statement (includes practice)

STEP 2 – Understanding the Process

  • How every problem is a process failure
  • How diagrams can set boundaries and define interrelationships
  • Using flowcharts to drill down into the right part of the process (includes practice)

STEP 3 – Identifying Possible Causes

  • Multiple ways to identify possible causes
  • Options for selecting or eliminating causes
  • Logic trees as a cause and effect diagram and other tools for investigations
  • Defining the Deviation
  • Identifying Root Cause
  • Corrective and Preventive Actions (CAPA)
  • What is the CAPA System
  • Definition and regulatory interpretation
  • Identifying and writing of corrective actions
  • Abuses of the CAPA system
  • Discuss robustness and effectiveness review
  • Management of the Investigation
  • Members of the Investigation Team
  • Consulting Case Study Practice – Incident/Events
  • Case Study Practice
  • Interactive Exercises and Discussions.

 

Unravelling the DHF, Technical File and Design Dossier

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Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD.

The Design History File

The history of the Design History File is an interesting one. It evolved out of the FDA’s realization, over time and experience; that the major part of a device’s problems was happening during the design stage and change phases, regardless of whether it was a new product or a changed one. This led to the birth of the concept of Design Control, aimed at tracking, monitoring and correcting the design elements at every stage from start to finish.

 

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Outstanding characteristics of the Design History File

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What should the Design History File contain?

The DHF should contain the following:

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Now, the Technical File and Design Dossier

In short and simple terms, one can understand the Technical File and the Design Dossier as the EU’s version of the Design Control and the DHF. In other words, what Design Control and Design History File are for the FDA; the Technical File and Medical Device (MDD) are for the Medical Device Directive.

What should the TF and DD contain?

These files should have all the basic sections needed to support the requirements of the Medical Device Directive (MDD), Essential Requirements (for that product), and the company’s “Declaration of Conformity” for that product:

  • General Information/Product Description/EC Authorized Representative
  • Classification Determination
  • Essential Requirements
  • Risk Analysis
  • Labeling
  • Product Specifications
  • Design Control
  • Clinical Evaluation
  • System Test Reports
  • Functional Bench Testing
  • Lab Testing
  • Sterilization validation (or AAMI TIR 28 Analysis)
  • Packaging Qualifications
  • Manufacturing
  • Sterilization
  • Conclusion
  • Declaration of Conformity
  • Appendix

Differences between the Technical File and Design Dossier

At a broad level, in general terms, while the Technical File is for MDD Class I and Class II a or II b; the Design Dossier is for MDD Class III devices

While Technical Files are retained in the premises of the manufacturer or the Authorized Representative for review of the Competent Authorities or/and Notified Body; Design Dossiers need to be submitted to the Notified Body for review before the product gets its CE-marking.

 

Learn more on this topic by visiting  :  http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900746SEMINAR?wordpress-SEO

 

 

New Way of Exploring Economic Environment

Lineament analysis in geological exploration

The existence of efficient and cost-effective methods that help to identify prospective targets that are related to or are influenced by tectonic structures is not common knowledge among professionals in the field of geological exploration.

The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process to achieve the best possible confidence in resultant mineral resource and reserve estimates.

Getting Quality Assurance and Quality Control procedures and protocols right is crucial

Accurate and proper QA and QC procedures and protocols are essential to ensure that data collected and created by the mining organization is of a high level of quality and is in compliance with CIM Standards and Guidelines. Geological quality control procedures are meant to monitor precision and accuracy of the assay data, as well as possible sample contamination during sample preparation and assaying. The quality of the data used determines the quality of an estimate.

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To offer a complete understanding of this concept, GlobalCompliancePanel, a reputable provider of professional trainings for all areas of regulatory compliance, will be organizing a two-day, live seminar. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900719SEMINAR?new-economic-environment-Boston-MA.

The Director of this seminar, Ricardo Valls, will introduce to the participants a methodology that will help them to concentrate their exploration efforts even over new areas with limited or nonexistent geological information, while keeping their budget in check.

The centrality of QA&QC procedures

Ricardo will explain how lineament and satellite interpretation are a way to define where to concentrate exploration efforts, as well as how to implement QA&QC procedures to guarantee the quality of the collected data. This is necessary, considering that compliance with the industry-established QA/QC is no longer an option, but a necessity for all the companies to implement, especially those that trade in the markets. Quality assurance is essentially the management system that operates to ensure credible results. The prime objective of the field QA program is to maximize accuracy by reducing introduced variability.

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The learning will be gleaned from a quality assurance program that the Director has implemented for the field sampling procedures. This includes collection, labeling, and shipping components. The quality control component of this system is a set of activities intended to control the quality of the data from collection through to analysis. It consists of day-to-day activities such as:

  • The adherence to written protocols; up-to-date and suitable training of personnel
  • The use of reliable laboratories with excellent QA&QC systems in place
  • The regular use of quality control (QC) samples (blanks, standard samples, and field duplicates)
  • Diligent record keeping.

Ricardo will cover the following areas at this seminar:

  • History of the problem, why we need to change the current approach
  • Lineament analysis
  • Lineament analysis and satellite interpretation of data
  • Physical modeling (3D strain analysis and 3D stress analysis)
  • Statistical procedures (Compositional data analysis, correlation analysis, principal component and other methods)
  • Defining a QA/QC program, Blanks, duplicates, standards, external controls
  • Procedures and audits
  • Rock naming in the field
  • Conclusions and recommendations.

Developing Documents and Records to meet the Requirement of ISO 17025

The major challenge for most laboratories is having to develop and implement a functional Quality Management System (QMS) that not only complies with the management and technical requirements of the ISO/IEC 17025:2005 standard, but also meets the laboratory’s needs. This is why QMS is considered the soul of the ISO/IEC 17025:2005 standard.

A highly meaningful and valuable learning session on how to accomplish this is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. The Director at this two-day seminar is Michael Brodsky, President of Brodsky Consultants and a Past President of the Ontario Food Protection Association (OFPA), The International Association for Food Protection (IAFP) and AOAC International. To enroll for this seminar, please log on to

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900445SEMINAR?developing-documents-records-SFO. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Compliance with ISO is a core requirement

A QMS that complies with the management and technical requirements of the ISO/IEC 17025:2005 standard is the core criterion for accreditation, as well as the backbone of this standard. Michael will familiarize participants with how with how laboratories can accomplish this in depth.

quality-management-system

The Quality System Manual (QMS) is indispensable in a QMS environment because, much like its predecessor –Good Laboratory Practice (GLP) –it contains the policies that the laboratory is expected to follow to achieve Quality results. However, it is only the “what to do” component of a QMS. What laboratories also need are the “how to do it” or procedures and methods, and equally importantly, the controls or evidence that it was done properly. These are the critical requirements that documentation has to address, and are what this seminar will cover.

Doesn’t end with accreditation

Achieving accreditation is only half the job done, because once this has been done, the tougher part –that of maintaining the QMS –begins. The high number of non-conformances cited during the subsequent biannual audits is proof of this fact. This seminar will explain how to maintain the QMS in the long run to the satisfaction of regulatory authorities, as well as to meet the laboratory’s needs.

Those in Laboratory Management/Supervision, Laboratory Quality Development, Laboratory Quality Management,  Laboratory Quality Control and Analytical support need to ask critical questions at the time of embarking on the process of developing documents and records that meet the requirements of ISO 17025, such as:

  • Why should we want to become accredited?
  • Where do we start?
  • If our laboratory is already accredited, how do we ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits?

Michael will help participants at this seminar develop the critical thinking that is essential for developing documents and records in compliance with ISO 17025.

The ISO 13485:2016 standard is new and needs to be looked at afresh

With the ISO making the final version of the ISO 13485:2016 standard available; it is now up to companies to start planning ways of implementing it. The major area in which it differs from the earlier version (of 2003) is in the extent of its alignment with the FDA’s Quality Management System (QMS) requirement. Although this version shows a higher level of this aspect; there still exist points of deviation from the FDA’s QMS, making this the area that companies that need to comply with this standard need to focus on.

In order to help such companies understand the ways of grasping the 2016 ISO 13485 standard better and to offer them insights into it; GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance area, is organizing a seminar.

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A learning session to help professionals understand the ISO 13485:2016 better

This seminar will offer clarity on how to implement the new ISO 13485:2016 standard. This seminar assumes significance in the light of the fact that not only is the new regulation quite complex; for many companies, the implementation period is quite short, depending on the expiry date of their current certificate.

More details of the seminar can be had from

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900592SEMINAR

The Director of this seminar, Dan O’Leary, who has experience of over 30 years in various quality, operations, and program management in regulated industries, will offer practical implementation advice and suggestions to participants. He will explain the points at which there is both convergence and divergence between this revised standard and the FDA’s QSR requirements. He will also show that the regulatory systems in a few jurisdictions will continue to depend on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP).

Areas of concurrence and departure

Dan will describe the areas in which the US and the EU differ in this regard. It is in these: The US will participate in MDSAP, but will not expect to change its regulations. On the other hand, the EU is not going to participate. It will implement its own published version, the EN ISO 13485:2016, and will continue with the existing Notified Body system. However, the EU will implement its own set of new regulations that will replace the directives. These will lead to new regulations that will be newer versions of EN ISO 13485:2016 and EN ISO 14971:2012.

In the course of this explanation, Dan will make use of exercises and examples with which participants will understand the ways of implementing according to the new guidelines. He will also use these to help them analyze the consequences of the newly revised regulation in a few regulatory systems including MDASP and its nonconformity grading system.