Forensic Expert via The Forensic Science Public Desk, India

Who is an Expert?

I am an expert in doing sketches. How? I am passionate about sketching and drawing since my childhood and still, I practice it. I take a very short time to do any kind of sketch within few minutes compared to the capability of any other common human. Hence, It can be said as he has expertise in the art of sketching and he has knowledge on sketching where he can form an opinion or comment on other work whether it is authentic, truly hard work, commendable work or possibilities and what were the possible ingredients used to make a certain sketch.

So that was an example which gives us a better understanding of who is an expert.

A person who has special knowledge and skill in a particular branch of learning and thus qualified to give his opinion, whereas, an ordinary person is not competent to do so.

Thus, Doctors, artists, engineers, surveyors, engravers, mechanics, artisans, and the diverse classes of specifically skilled workmen would all be experts within the meaning of the expert, of course, each in his walk of life.

How can you be one? 

Crimes are associated with the number of evidence like blood, bullet or a dead body. Identification or classifying any of this would easy due to definite science which is available as the experience of individuals working with a field like serologists, Ballistic experts or Doctors. This particular aspect can be learnt and it can apply to

Section 45 in The Indian Evidence Act, 1872

Opinions of experts.—When the Court has to form an opinion upon a point of foreign law or science or art.

What is foreign law or science or art? Means, Court is represented by personnel’s dealing with law and justice enforced for public welfare. I pursuit of justice there are certain aspects which are also involved like science. Representatives of court, that is judges or law Practitioners are not aware of these particular sciences like serology or physics or medicine nor they can complete the degree in few days nor they can be unethical by justifying anything on their own. They are knowledgeable personnel’s in enacting law and justice for public welfare but not to justify truth hidden within the scientific evidence like nature of injury on the body or striation marks on the bullet.

Hence, the Court needs to rely on expert opinion to understand the significant scientific evidence role of any kind of case dealt with in the court.

Examples

Doctor: As to ascertain the cause of death or time since death

Chemical examiner: identification of a questioned substance by conducting chemical examination which approved by scientific statutory bodies.

Ballistics expert: identification of alleged firearm by comparing test-fired bullet and questioned bullet.

Court believes science-based literature, research held and scientific principles or laws developed during a search of the reality behind happenings of many unknown things to mankind.

Whom will you handover the evidence to?

Just imagine if you are having an Evidence which is a “Document with disputed signature, questioned age of ink in the signature and contents on the questioned document” Whom will you handover the evidence to?

One who has just completed Masters in Forensic Science – has experience practice with demo samples or simulated samples or experience while in internship or project under the supervision of an expert. The court cannot rely on you leaving behind qualified experts but you should be having the capability to convince the court in the science subject matter thus makes you an expert. Anybody one who can prove or involve in the scientific examination of the evidence on the grounds of being intellectual in scientific principles and law which are in current practice by many of the recognized scientists can be referred and can be used to prove the truth hidden with evidence. This can be regarded as the private practice of forensic consultancy.

According to IEA 45, an opinion formed by an expert is based on recognized principles regulating the scientific study. The opinion so formed by a person having the necessary special skill in the subject is, therefore, the opinion of an expert in that branch of the science. Such an opinion is the opinion of an expert in a branch of science which is admissible in evidence under Section 45 of the Indian Evidence Act. (or)

One who has 10 years of experience dealing with similar types of cases as an expert – Similar kind of cases here means, there is plenty of complications involved in dealing with crime evidence. Hence, Experience will be vast and much expertise in nature. Many of the times experts may fail to form an opinion and where by the court will justify such conflict by itself being expert by considering other circumstantial evidence and facts of the case. Under section 73 IEA.

Though Section 73 deals with Comparison of signature, writing or seal with others admitted or proved. It has also relevance with the explanation given for court expertise.

Patna High Court State (Through Cbi) vs S.J. Choudhary on 13 February, 1996

Are there any designated experts recognized by the court?

Yes, Forensic Science Laboratories personnel’s under section 293 says Reports of certain Government scientific experts. Subsection 4 applies to the Government scientific experts, namely:-

(a) any Chemical Examiner or Assistant Chemical Examiner to Government; of Forensic Science Laboratories or Govt. Chemical Examiners Laboratory.

(b) the Chief Inspector of- Explosives; current position is Joint Chief Controller of Explosives (HOD) of Petroleum & Explosives Safety Organization (PESO).

(c) the Director of the Finger Print Bureau; both state level and central level.

(d) the Director, Haffkeine Institute, Bombay; as a bacteriology research Centre called the “Plague Research Laboratory”. It now offers various basic and applied biomedical science services.

(e) Director, Deputy Director or Assistant Director] of a Central Forensic Science Laboratory or a State Forensic Science Laboratory;

(f) the Serologist to the Government. Head of Institute of Serology that is Serologist & Chemical examiner or Assistant serologists.

So these people are regarded as experts in the court officially or they can also appoint assistants working with case actually under subsection 3 of Cr.P.C 293

 

This article will help to understand forensic expertise, the role of an expert in criminal justice system by providing suitable examples accordingly Indian Evidence Act Sections 45 & 73 and also gives a glance on government scientific experts under section 293 of Criminal Procedure Code.

via Forensic Expert — Forensic Science Public Desk, India

Arson Investigation Dogs Can Detect Traces of Gasoline as small as 1 Billionth of a Teaspoon via Crime Scene to Court 

Arson Canine  East  Texas Nina Lab ATF
ATF ADC, Nina
Photo: Mark Moore; Gregg County, Texas Fire Marshal

New research out of the University of Alberta – Canada, finds that dogs can detect gasoline in quantities as small as one billionth of a teaspoon.

Daisy, an accelerant detection canine from Westchester County, New York works with her partner Detective John V. Peters.
Photo: US Fire Administration

Canines have been used in arson investigations for about 30 years, beginning when the US ATF partnered up with the Connecticut State Police in 1986 to train an accelerant detecting canine (ADC) named Mattie.

Mattie was a Labrador Retriever, working for the Connecticut State Police, and she was trained to alert to 17 different ignitable liquids. We all know that Mattie and her kind have an incredible sense of smell, but just how sensitive, is amazing.

Dogs typically have about 200 million receptor cells in their noses that help them identify scents and odors, compared to about 5 million cells in a human nose. Further increasing their sense of smell is an organ located in the roof of their mouths that allows them to basically “taste” a smell.

Mando the Chihuahua
Mando

Just like a human, a dog can smell an odor that comes directly from an item, and like us, they can smell an odor left on a surface after the source of the odor has been removed, the difference is that a dog’s sense of smell eclipses ours, and it even beats electronic equipment designed for hydrocarbon detection.

In fact, man made odor detecting devices detect hydrocarbon components in the neighborhood of parts per million, where dogs an detect amounts as small as .01 micro liters. And if that wasn’t enough to favor the dog, a dog pinpoints the area of the source odor, where a man made instrument cannot.

Lastly, a dog can actually differentiate between true accelerants and similar gases that an instrument cannot do.

K9’s are often used in arson investigation, allowing investigators to locate items and debri that presumptively contains accelerants. These areas shown as “hits” by the dog will be collected, and sent to a lab for scientific analysis.

Click the link below for more info on accelerant detecting K9’s.

 

via Arson Investigation Dogs Can Detect Traces of Gasoline Down to 1 Billionth of a Teaspoon — Crime Scene to Court 

How to Catch a Liar via Brainwave Science

According to Brainwave Science an average person hears about 200 lies every day. It is no surprise as we learn how to lie in our early development stages and by the time we become adults, we get pro at lying! The only catch here is the question, ‘how to catch a liar?’

Technological advancements in different fields of crime scene investigation have drastically changed the landscape. Today, law enforcement can use technology to detect and solve criminal activity happening at the moment. The approach is more proactive than reactive. Forensic Science has completely changed the way crimes are investigated, prosecuted, and adjudicated.

Biometrics work very well to confirm the identity of the person. They are being utilized in ID cards, bank cards, phones, and other technological devices and come in various forms such as fingerprints, irises, voice patterns, and the spatial geometry of the faces, etc. Biometric systems must be able to accommodate changes to the biometric over time which may be caused by aging, illness, or injury.  Let us not forget though that external subject identification via its Automated Biometrics Identification System aims to ensure national security and public safety. It can only, however, identify the person’s identity externally, but not the mind and schemes of the person.

Brain Fingerprinting – This technique is quite ideal for discovering if a piece of information is collected in a person’s brain through EEG. It correctly measures the electric brainwaves science which helps us tap into the person’s familiarity with the crime scene. The major challenge in using this technique is the need for extensive training and the cumbersome nature of software and hardware application needs specialized neuroscientists to administer tests that may not be learned by investigators. It is more of a service-based model where the expert is needed to constantly conduct testing.

iCognative technology is the only available neuroscience-based forensic technology that is over 99.9% accurate, applicable in almost all investigations, is based on proven P300 science, has been used in over 100 real-life cases, and is virtually unbeatable. Today many countries and intelligence agencies in the world are already reaping the benefits afforded by it. To top it all it supports human rights and eliminates torture.

iCognative technology:

  • identifies criminals from innocents, detects presence or absence or information in the brain
  • specifically screens privileged information holders, specific training like IED/EOD bomb-making
  • helps apprehend terrorism and crime supporters and sympathizers
  • helps identify foot soldiers from kingpins in organized crimes
  • successfully detects intent to harm and cause violence

distinguishes between witness and perpetrator

DNA and Fingerprints are the first go-to methods for all investigations. They are accepted as a piece of evidence in the court of law. However, the issue with them is that the crime scene must remain uncorrupted and the collection of evidence must be done properly to eliminate cross-contamination. Preservation of these evidence is also a labor-intensive task that must be conducted by professionals who have been extensively trained in this field.

Lie Detector/Polygraphs are not accepted as evidence but are extensively used by law enforcement agencies to eliminate innocents from the suspects. The accuracy rates of Lie detectors or Polygraph has been hotly debated. People are able to beat them, and the interpretation of results is done subjectively by the examiner. Most psychologists agree that there is little evidence that polygraph tests can accurately detect lies – American psychological Association (APA)

 

Did you know that an average person hears about 200 lies every day? It is no surprise as we learn how to lie in our early development stages and by the time we become adults, we get pro at lying! The only catch here is the question, ‘how to catch a liar?’ Technol

Maggot Analysis with Mass Spectrometry via Locard’s Lab

A new proof-of-concept study by researchers at the University at Albany in New York has developed a mass spectrometry-based technique for the rapid species prediction of blow fly larvae for use in forensic investigations.

Entomological evidence (evidence relating to insects) has proven invaluable to forensic investigations for decades, particularly in the estimation of time since death. Insects which feed on decomposing remains, known as necrophagous insects, will colonise a body in a reasonably predictable pattern, with different insects arriving at different stages throughout the decomposition process. Different species of flies, beetles and mites are commonly encountered. Blow flies in particular will often arrive at the scene within minutes of death to lay eggs on the body. As these eggs hatch, larvae (or maggots) emerge to feed on the decomposing remains. By studying the type and age of insects present at a scene, it may be possible to estimate the time since death, or postmortem interval.

The ability to achieve this hinges on the correct identification of insect species, which is unfortunately not always straightforward. The larvae of different species of blow fly are visually very similar, thus difficult to distinguish by eye. For this reason, maggots are often reared to maturity for species identification, with adult blow flies exhibiting more distinguishing physical differences. Inevitably the rearing of maggots to adulthood is a time-consuming process that requires the expertise of a forensic entomologist.

In recent years, researchers have tried to develop more rapid approaches to insect species identification, particularly using chemical analysis. Researchers at the University at Albany in New York have been applying direct analysis in real time mass spectrometry (DART-MS) to the analysis of insect evidence to provide a rapid species identification tool. In DART-MS, the sample is placed between the DART ion source and the inlet of the mass spectrometer, allowing chemical components in the sample to be ionised and drawn into the MS for direct analysis. DART-MS requires minimal or no sample preparation and results can be obtained almost instantly. Using this technique, Rabi Musah and her team have already demonstrated the ability to determine the species of larvae, pupae and adult flies, highlighting a promising new tool in rapid species identification in forensic entomology.

However, until now this research has focused on the analysis of individual species. In a real-world scenario, maggots present on the body may consist of multiple different species, therefore any techniques developed for rapid species identification of larvae must be able to work with mixed samples. In a recent study, the team have taken the method one step further by examining the potential to identify larvae from mixed species.

Blow flies of various species were collected from Manhattan, New York. Maggots were submerged in 70% ethanol and the solution exposed to the ion source of the DART-MS to produce chemical signatures of both individual species and combinations of species. Mixtures of two, three, four, fix and six different species were analysed. Using the chemical profiles produced, a predictive model was constructed for the subsequent identification of unknown insect samples. Using this model, maggot species could be established with an accuracy of up to 94% and a confidence interval of 80-95%. Individual insect species are readily differentiated, with different species producing distinct chemical profiles. Similarly, mixtures of two different species could also be differentiated. As might be expected, samples containing a higher number of species were more difficult to differentiate.

Although only a proof-of-concept study and further validation is required, the study demonstrates that DART-MS could offer a way of rapidly determining the species of blowfly larvae, thus allowing investigators to establish which insects are present at the scene of a death and work out postmortem interval faster.

 

Beyramysoltan, S. Ventura, M. I. Rosati, J. Y. Giffen, J. E. Musah, R. A. Identification of the Species Constituents of Maggot Populations Feeding on Decomposing Remains—Facilitation of the Determination of Post Mortem Interval and Time Since Tissue Infestation through Application of Machine Learning and Direct Analysis in Real Time-Mass Spectrometry. Analytical Chem, 2020, In Press. 

A new proof-of-concept study by researchers at the University at Albany in New York has developed a mass spectrometry-based technique for the rapid species prediction of blow fly larvae for use in forensic investigations. Entomological evidence (evidence relating to insects) has proven invaluable to forensic investigations for decades, particularly in the estimation of time since […]

via Maggot Analysis with Mass Spectrometry — Locard’s Lab

4 alternative ways to analyze personality via Inspiring enlightened living

“Why am I as I am? To understand that of any person, his whole life, from birth must be reviewed. All of our experiences fuse into our personality. Everything that ever happened to us is an ingredient.” ― Malcolm X, The Autobiography of Malcolm The dawning of a new year brings a fresh opportunity to […]

via 4 alternative ways to analyse personality — Inspiring enlightened living

#Forensics: Contextual bias influences jury outcomes via CSIDDS

When police lab results are weak or ambiguous, juries commonly use non science circumstances to increase its value. https://phys.org/news/2019-10-csi-current-impact-bias-crime.html

via #Forensics: Contextual bias influences and weak forensic testing results leads to jury overestimation of guilt — FORENSICS and LAW in FOCUS @ CSIDDS | News and Trends

7 Countries with the Best Forensic Technologies via iTHINK

Civilizations that have thousands of years invested in perfecting a field tend to NAIL IT with more accuracy….

Many research and development solutions can be obtained through information sharing from countries that have had centuries of trial and error based experiementation. Seek to learn from mentors in the field, and save yourself from complicating your analysis.

7 Countries with the Best Forensic Technology

7. China

Technology

China has been investing time, energy and resources into forensic science since the 1980’s and globally-renowned forensic scientist Henry Chang-yu Lee believes it’s about to pay off tipping China to become a world leader in high-tech evidence collection.

“I believe the technology in China will be more advanced than ever in the United States within five years,” the Chinese-American expert said in a recent interview with China Daily.

Lee, who has racked up more than five decades of experience in forensic science, has worked on a number of high-profile criminal cases in the US, but has also shared his wealth of knowledge with students, lawyers, judges and law enforcement in China over the years.

“The apparatus and devices used to identify fingerprints or footprints, for example, were very simple when I first visited Chinese forensic laboratories,” he said.

However, he has seen the technology improve over the years and there have been many advances, particularly in electronic evidence collection and fraud prevention by means of real-time monitoring.

In 2016, Lee and several other experts established the Silk Road Forensic Consortium in Xi’an, Shaanxi province, to fight crime and safeguard security by boosting scientific exchanges among countries involved in the Belt and Road Initiative.

The consortium, which has 150 members from 30 countries and regions, provides an open platform for forensic specialists, police officers and judges to share ideas and difficulties as well as experiences in DNA identification studies.

Lee, who acts as chairman, said, “Although we speak different languages in our daily lives, we all speak the same ‘language’ at work, and that’s the language of the criminal investigation. We share the same goal – to speak for the dead using forensic science.”

In September, at the organisation’s third annual conference in Yantai, Shandong province, Lee announced plans to unify DNA identification standards among its members to try and build a mutual DNA database that can better solve criminal cases.

Unified standards are essential to the world of forensic science, he told China Daily.

“If we can achieve unification in China, it can be extended across Asia, to the consortium and finally the world,” he added. “It would mean a brighter future for forensic science.”

6. European Network of Forensic Institutes

Although not a country, the European Network of Forensic Institutes (ENFSI) is recognized as a pre-eminent voice in forensic science worldwide. It is a network of forensic specialists covering a broad range of fields of expertise, from 38 countries geographically spread across Europe:

Austria, Armenia, Azerbaijan, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Former Yugoslav Republic of Macedonia, Malta, Montenegro, The Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovenia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine and the United Kingdom.

The ENFSI has seventeen Expert Working Groups working on a diverse range of forensic specialisms, from textiles and hair to explosives and firearms. It also provides invaluable training to police officers and crime scene investigators.

5. Germany

Technology

Police in the German state of Bavaria have the power to use forensic DNA profiling after a controversial law passed in 2018 in the Landtag, the state parliament in Munich. The law was the first in Germany to allow authorities to use DNA to help determine the physical characteristics, such as eye colour, of an unknown culprit.

The new DNA rules are part of a broader law which has drawn criticism of the wide surveillance powers it gives the state’s police to investigate people they deem an “imminent danger,” people who haven’t necessarily committed any crimes but might be planning to do so.

The move was prompted, in part, by the rape and murder of a medical student in Freiburg, Germany, in late 2016. An asylum seeker, originally from Afghanistan, was convicted of the murder and sentenced to life in prison.

But some authorities complained that they could have narrowed their search more quickly if they had been able to use trace DNA to predict what the suspect would look like.

Federal and state laws previously only allowed investigators to use DNA to look for an exact match between crime scene evidence and a potential culprit, either in a database of known criminals or from a suspect.

Germany also forms part of the aforementioned ENFSI.

4. South Korea

To say that smartphones have changed the digital forensic landscape is an understatement. The device has become the core of every criminal investigation and helped propel digital forensics as a serious, scientific investigation tool.

South Korea is leading the way in digital forensics, with its largest digital forensic firm, Hancom GMD, playing a crucial role in prosecuting some of the country’s most powerful politicians.

In late 2016, South Korea was rocked by one of its biggest political corruption scandals in history – its President Park Guen-hye was accused of bribery and by law, investigators only had 60 days to investigate and prosecute.

They had confiscated over 300 smartphones as from suspects and needed to analyse tens of thousands of phone records and chat messages within a tight deadline. Hancom GMD successfully analysed all of the data in the 300 smartphones and extracted crucial evidence that led to several convictions.

With 5G set to be rolled out globally this year, forensic teams in South Korea are already preparing for this further growth in the collection of digital evidence.

Hancom GMD is planning to launch a service that recovers data from the cloud, though privacy regulations in each country are expected to be a challenge to overcome.

3. United Kingdom

Technology

Prior to its closure in 2012, the UK Forensic Science Service (FSS) was a world-leader in forensic technology. It pioneered the use of the handheld breath alcohol roadside tester and the DNA national database was first worked on and initially tested on all staff and police forces to ensure its reliability.

The organisation later pioneered the use of large scale DNA profiling for forensic identification and crime detection when it moved the facilities to Birmingham.

This enabled the launch of the world’s first DNA database on 10 April 1995. The FSS’s innovative and highly sensitive DNA profiling technique called LCN (low copy number) was used in convicting Antoni Imiela (the M25 rapist).

As well as,  Ronald Castree (for the murder of Lesley Molseed in 1975) but the organisation came under attack when it failed to recover blood stains from a shoe in the murder of Damilola Taylor.

Forensic laboratories in the UK are now privately-owned but are experiencing similar financial difficulties, a recent inquiry by the House of Lords heard.

Mark Pearse, the commercial director in the forensics division of Eurofins, one of the three major providers in the UK, described an “unsustainable toxic set of conditions” when he appeared before the inquiry.

Representatives from the two other largest providers – Key Forensics, which had to be bailed out by police last year after going into administration, and Cellmark – raised similar concerns.

However, that’s not to say that the UK is not involved in researching and implementing new forensic technologies.

Forensic scientists are currently working with the British military to open the United Kingdom’s first body farm — a site where researchers will be able to study the decomposition of human remains.

Details are not yet finalized, but the plans are at an advanced stage: project leaders hope this year to open the farm, also known as a forensic cemetery or taphonomy facility, after the discipline devoted to the study of decay and fossilization.

Such sites generate data on tissue and bone degradation under controlled conditions, along with chemical changes in the soil, air and water around a corpse, to help criminal and forensic investigators.

2. The Netherlands

The Netherlands Forensic Institute (NFI) is one of the world’s leading forensic laboratories. From its state-of-the-art, purpose-built premises in The Hague, the NFI provides products and services to a wide range of national and international clients.

To ensure that their work remains at the forefront of developments, the Netherlands Forensic Institute invests heavily in Research and Development. In this way, it lays the foundations for innovative forensic methods and technologies that will play an important part in the coming decades.

Amongst these innovative forensic technologies is the invention of Hansken, a system that can store large quantities and diverse data easily from different sources. All data is stored, indexed, enriched and made rapidly searchable, cutting down the turnaround time of forensic evidence.

It now contains over 150 samples of glass from a large number cases. In several cases, this glass database has linked suspects to several crimes.

Offenders who carry out robberies, smash-and-grab raids or ARM gas attacks may have splinters of glass on their clothes or in the soles of their shoes and these splinters of glass can remain in place for months, even though they are barely visible to the naked eye, if at all.

These splinters can be of great value. The composition of each piece of glass is unique because of minuscule contaminants in the raw materials for making glass.

By comparing the unique composition of splinters of glass found on a suspect to glass from the database, it is possible to check whether that glass originates from a crime committed earlier.

The glass analysts of the NFI measure the concentration of twenty elements in each piece of glass. This produces a kind of ‘chemical fingerprint’ of the material.

1.United States of America

Technology

It will come as no surprise that at the forefront of cutting-edge forensic technology is the USA, home to over 400 crime labs and the biggest crime lab in the world, the FBI Laboratory.

 

To help train government and industry organisations on cyberattack prevention, as part of a research project for the U.S. Army, scientists at The University of Texas at San Antonio, have developed the first framework to score the agility of cyber attackers and defenders.

“The DOD and U.S. Army recognize that the cyber domain is as important a battlefront as ground, air and sea,” said Dr. Purush Iyer, division chief, network sciences at Army Research Office, an element of the Army Futures Command’s Army Research Laboratory.

“Being able to predict what the adversaries will likely do provides opportunities to protect and to launch countermeasures. This work is a testament to successful collaboration between academia and government.”

The framework developed by the researchers will help government and industry organizations visualize how well they out-maneuver attacks.

Their work is published in IEEE Transactions on Information Forensics and Security, a top journal for cybersecurity.

Education and training programs in the field of forensics are also on the rise, supported by organisations such as The Forensic Sciences Foundation and the American Academy of Forensic Sciences.

In fact, there are 485 Forensic Science schools in the US, so it’s no wonder that it is the home of the some of the most influential forensic scientists, such as Dr. Michael M. Baden and Ellis R. Kerley, and is sure to produce a great deal more talent in the future.

This is certainly an exciting time to be working in forensic science, with the challenges presented by the world of AI, Smartphones and Cloud data calling for rapid improvements to existing technology.

With these challenges comes the need for those countries with more developed forensic facilities to provide training and education opportunities to those in less developed areas so that science can play its rightful part in the criminal justice system.

For now, these are among the 7 countries who have the most advanced forensic technology and it is not the end. As the world continues to evolve, so will technology and the forensic industry itself.

Hi! I’m Isabella and I’m an Italian living in the UK studying for a Masters in Crime & Justice. I currently work in the prison education sector and have a background in teaching, having completed a PGCE after reading languages at the University of Durham. I love travelling, cooking, reading and playing the piano.

Technology is at its peak moment and with it has bought about some of the finest forensic techs. Here are 7 countries with the best forensic technology.

via 7 Countries with the Best Forensic Technology — iTHINK

Essentials Of Educational Protocols – Do You Really Need Them?

ISO 13485
ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

This standard supersedes earlier documents such as EN 46001 and EN 46002, the previously published ISO 13485, and ISO 13488.

The essentials of validation planning, protocol writing, and change management will be explained.

via ESSENTIALS OF VALIDATION – Do You Really Need It? — Compliance4all

How to Evaluate a Statistic and avoid Bias / False Presumptions via Mathematical Software

A counting statistic is simply a numerical count of the number of some item such as “one million missing children”, “three million homeless”, and “3.5 million STEM jobs by 2025.” Counting statistics are frequently deployed in public policy debates, the marketing of goods and services, and other contexts. Particularly when paired with an emotionally engaging story, counting statistics can be powerful and persuasive. Counting statistics can be highly misleading or even completely false. This article discusses how to evaluate counting statistics and includes a detailed list of steps to follow to evaluate a counting statistic.

Checklist for Counting Statistics

  1. Find the original primary source of the statistic. Ideally you should determine the organization or individual who produced the statistic. If the source is an organization you should find out who specifically produced the statistic within the organization. If possible find out the name and role of each member involved in the production of the statistic. Ideally you should have a full citation to the original source that could be used in a high quality scholarly peer-reviewed publication.
  2. What is the background, agenda, and possible biases of the individual or organization that produced the statistic? What are their sources of funding?What is their track record, both in general and in the specific field of the statistic? Many statistics are produced by “think tanks” with various ideological and financial biases and commitments.
  3. How is the item being counted defined. This is very important. Many questionable statistics use a broad, often vague definition of the item paired with personal stories of an extreme or shocking nature to persuade. For example, the widely quoted “one million missing children” in the United States used in the 1980’s — and even today — rounded up from an official FBI number of about seven hundred thousand missing children, the vast majority of whom returned home safely within a short time, paired with rare cases of horrific stranger abductions and murders such as the 1981 murder of six year old Adam Walsh.
  4. If the statistic is paired with specific examples or personal stories, how representative are these examples and stories of the aggregate data used in the statistic? As with the missing children statistics in the 1980’s it is common for broad definitions giving large numbers to be paired with rare, extreme examples.
  5. How was the statistic measured and/or computed? At one extreme, some statistics are wild guesses by interested parties. In the early stages of the recognition of a social problem, there may be no solid reliable measurements; activists are prone to providing an educated guess. The statistic may be the product of an opinion survey. Some statistics are based on detailed, high quality measurements.
  6. What is the appropriate scale to evaluate the counting statistic? For example, the United States Census estimates the total population of the United States as of July 1, 2018 at 328 million. The US Bureau of Labor Statistics estimates about 156 million people are employed full time in May 2019. Thus “3.5 million STEM jobs” represents slightly more than one percent of the United States population and slightly more than two percent of full time employees.
  7. Are there independent estimates of the same or a reasonably similar statistic? If yes, what are they? Are the independent estimates consistent? If not, why not? If there are no independent estimates, why not? Why is there only one source? For example, estimates of unemployment based on the Bureau of Labor Statistics Current Population Survey (the source of the headline unemployment number reported in the news) and the Bureau’s payroll survey have a history of inconsistency.
  8. Is the statistic consistent with other data and statistics that are expected to be related? If not, why doesn’t the expected relationship hold? For example, we expect low unemployment to be associated with rising wages. This is not always the case, raising questions about the reliability of the official unemployment rate from the Current Population Survey.
  9. Is the statistic consistent with your personal experience or that of your social circle?If not, why not? For example, I have seen high unemployment rates among my social circle at times when the official unemployment rate was quite low.
  10. Does the statistic feel right? Sometimes, even though the statistic survives detailed scrutiny — following the above steps — it still doesn’t seem right. There is considerable controversy over the reliability of intuition and “feelings.” Nonetheless, many people believe a strong intuition often proves more accurate than a contradictory “rational analysis.” Often if you meditate on an intuition or feeling, more concrete reasons for the intuition will surface.

(C) 2019 by John F. McGowan, Ph.D.

About Me

John F. McGowan, Ph.D. solves problems using mathematics and mathematical software, including developing gesture recognition for touch devices, video compression and speech recognition technologies. He has extensive experience developing software in C, C++, MATLAB, Python, Visual Basic and many other programming languages. He has been a Visiting Scholar at HP Labs developing computer vision algorithms and software for mobile devices. He has worked as a contractor at NASA Ames Research Centerinvolved in the research and development of image and video processing algorithms and technology. He has published articles on the origin and evolution of life, the exploration of Mars (anticipating the discovery of methane on Mars), and cheap access to space. He has a Ph.D. in physics from the University of Illinois at Urbana-Champaign and a B.S. in physics from the California Institute of Technology (Caltech).

 

 

A counting statistic is simply a numerical count of the number of some item such as “one million missing children”, “three million homeless”, and “3.5 million STEM jobs by 2025.” Counting statistics are frequently deployed in public policy debates, the marketing of goods and services, and other contexts. Particularly when paired with an emotionally engaging […]

via How to Evaluate a Counting Statistic — Mathematical Software