Today’s Pre control and Statistical Process Control (SPC)

Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.

SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that carrying changes out is neither practicable nor useful.

Examples of process changes that SPC helps to detect include trends, shifts and variation. Three items are needed for SPC to meet its goal:

o  A system that measures effectiveness in real-time

o  Tolerance that is practical and is connected to customer keenness and satisfaction

o  A dial indicator that comes with an anticipated response.

All these help SPC to determine whether a process is stable and requires no adjustment, is incapable of performing its functions altogether, or is deviating but capable.

And now, pre-control

Pre-control, on the other hand, inspects the units and adjusts the process and the succeeding sampling procedures assuming where the measurements are placed in relation to the specification limits. The focus of pre-control is individual measurements.

It uses a set of probabilities, based on assumed distributions and the location of the process, to estimate where there is a justification for the process adjustments. Since decisions concerning pre-control are based broadly, i.e., on the area in which the measurements; it obviates the need for charting, as it is very responsive to the process signals right from the start.

SPC or pre-control?

There are arguments for and against the use of SPC and pre-control as an effective means of ensuring that the process is right and that it results in the desired quality for the product.

At a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, the speaker, Jd Marhevko, who has been involved in Operations and Quality/Lean/Six Sigma efforts across a variety of industries for more than 25 years, will explain all the aspects of pre-control. To hear her perspective of pre-control, please register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501074?Linkedin-SEO

What makes this webinar special is that it has consistently ranked in the top 1-5% at previous conferences at more than five venues. It was featured in ASQ QMD’s special edition of the Quality Management Forum’s 2015 Spring edition (ASQ-QM.org). A webinar of this topic was provided in 2015 via the ASQ QMD Linkage Technical Committee to over 1300 respondents through the IMA and ASQ QMD.

Tools needed for pre-control

At this hour-long session, Jd will explain all the elements of pre-control in Quality. she will show to participants the way of drafting and creating a pre-control chart. She will run a process in which to model the next steps and decisions.

The aim of this session is to equip participants with the knowledge needed for reducing the complexity of the system and bringing about an improvement in the effectiveness and efficiency of their Quality Management Systems.

A session packed with interaction and practical application of principles

A major component of this webinar on SPC and pre-control is that Jd will share the result of case studies. The knowledge gained at this webinar can be applied immediately at their work in respect to the following:

–       Measurement System Analysis (MSA): Jd will conduct a high level overview of MSA. This will help the participants get a grasp of the need for putting an effective measuring system in place ahead of implementing pre-control

–       Cpk Overview: To help participants gain baseline capability in advance of implementation of pre-control, a high level Cpk overview will be conducted

–       Normal Distribution: The way in which the cumulative distribution function of the normal distribution is to be used for estimating and establishing the zones on a pre-control chart

–       Pre-Control Chart: Jd will show participants how to apply the concepts listed above with the use of a mock pre-control chart where the process will be demonstrated based on the “go/no go” zones that are established.

At this webinar, Jd will cover the following areas of pre-control:

o  Reduce process complexity and minimize risk

o  Increase affectivity of a Core Tool

o  Increase personnel compliance in proactive process management.

https://www.isixsigma.com/tools-templates/control-charts/using-control-charts-or-pre-control-charts/

http://www.symphonytech.com/articles/pdfs/precontrol.pdf

http://www.winspc.com/what-is-spc/ask-the-expert/400-pre-control-no-substitute-for-statistical-process-control

http://www.qualitymag.com/articles/86794-pre-control-may-be-the-solution

Corrective and Preventive Action (CAPA) is vital to the life sciences

Corrective and Preventive Action (CAPA) is of the essence in any industry. The importance of CAPA is all the more pronounced in the life sciences industry, considering the importance of this discipline on human lives. It is the very core of a sound management system. CAPA, as the name suggests, is a set of preventive and corrective measures that need to be taken to ensure that the product meets its quality and regulatory expectations.

The essence of CAPA for the life sciences is that it should build the ability to respond to problems as they arise, but more importantly, a CAPA system should help the life sciences organization to anticipate and thus prevent problems from happening.

CAPA in the life sciences is an amalgamation of the following core ingredients:

o  Change Control

o  Continuous improvement

o  Complaint management

o  The need for understanding and implementing CAPA

CAPA is the very edifice of Quality Management. It is a sine qua non for meeting regulatory requirements. Its importance to the life sciences industry vis-à-vis the FDA can be gauged from the fact that in just four years starting 2012, the number of Warning Letters the FDA issued shot up by over 12 times. Understanding and implementing the right CAPA system is critical to meeting regulatory requirements and preventing such actions from the FDA.

Common pitfalls of CAPA implementation

Many life sciences organizations face a few obstacles when it comes to CAPA implementation. The most common ones among these are:

o  Failure to achieve an integrated view of the whole process that can be managed from any source

o  Lack of understanding of the highly intricate and difficult processes

o  Not documenting every step of the CAPA process

o  Lack of clarity between what a corrective and preventive action is

o  Not implementing uniform process across the product’s or company’s numerous sites.

An important line of thinking that needs to go into approaching CAPA is that understanding failures is as important as understanding success of a product in the life sciences industry if it has to meet quality and regulatory requirements. Understanding and correcting problems before they become critical and impede the product’s progress are vital to ensuring quality and meeting regulatory requirements.

Given the extremely high importance CAPA has in the regulated industries; it is but natural that there are a number of regulations that govern this area of the life sciences. How does an organization get an understanding of these regulations right? How does it enforce these regulations in the right manner, so that its products meet the regulatory and quality requirements?

Learn to get these aspects right

All these will be the topic of a highly valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm, will be the speaker. To gain proper and complete insights into all the areas of CAPA for the life sciences, just register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501216?Wordpress-SEO

At this session, Charles will explain how to apply core aspects of the CAPA process that includes:

o  The critical steps

o  The timing of CAPA

o  Who all in the organization need to take part in the process

o  Their roles, responsibilities and functions, and

o  The snags and hazards with CAPA investigation into the process.

The content of this webinar is designed to help participants achieve a highly effective CAPA system. It will help explain the purpose and function of CAPA, by which they will be able to:

o  Identify and explain the relevant CAPA regulations

o  Define exception/deviation reporting and explain the process of executing the reporting process

o  Explain and trace the CAPA flow from problem identification to resolution

o  Explain the challenges and pitfalls of the CAPA process and how they are overcome.

o  Explain CAPA’s role in risk mitigation.

o  Explain how root cause analysis is executed.

At this very valuable session, Charles will cover the following areas of CAPA for the life sciences:

o  CAPA defined

o  CAPA relevant regulations

o  Exception/deviation reporting

o  CAPA process flow

o  CAPA process steps explained

o  Challenges and pitfalls of CAPA’s

o  CAPA and risk mitigation

o  Root Cause Analysis.

http://www.meritsolutions.com/life-sciences/top-8-pitfalls-and-challenges-of-life-sciences-capa-systems-and-processes/

Taxable and nontaxable fringe benefits

The Internal Revenue Service (IRS) has guidelines and laws for the way fringe benefits have to be taxed. First, an introduction to fringe benefits: Anything that is in addition to a person’s regular salary may be termed a fringe benefit. It is usually linked to an employee’s performance. Some of the common types of fringe benefits include children’s education, vehicle for commuting to the workplace and back, health insurance, retirement benefits and many others.

The IRS taxes certain kinds of fringe benefits that come under designated categories, while some other kinds of fringe benefits are not taxed. Taxable and nontaxable fringe benefits are a major aspect of taxation laws in the US and have to be implemented in strict accordance with what is set out in the law. There is a long list of taxable and nontaxable fringe benefits.

A few examples of nontaxable fringe benefits

Stock options, employee discounts, savings that are made for retirement planning and other related benefits are part of nontaxable fringe benefits. Also, certain types of De Minimis benefits, depending on their value, need not be accounted for and filed under W-2.

A few examples of taxable fringe benefits

Other fringe benefits like accident benefit, vehicle that is provided from an employer and is for personal use, expenses incurred on vacation, and many other types of benefits are taxable and have to be accounted for and filed.

When declaring and filing these, the right method has to be followed. Filing for the said taxable and nontaxable fringe benefits has to be done under the appropriate head, following the right procedures. The right knowledge has to go into understanding what to consider as taxable fringe benefits and what to classify as nontaxable fringe benefits. Claiming the fair market value of taxable fringe benefits is of the essence in making the declaration of taxable and nontaxable fringe benefits.

Get to understand how to follow the right procedures for taxable and nontaxable fringe benefits

To gain a complete understanding of these aspects of the IRS, please enroll for a valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. This session will give a complete understanding of how to classify taxable and nontaxable fringe benefits.

At this important webinar, Greta Hicks, who is a former IRS Revenue Agent and Regional Training Coordinator, will be the speaker. She will take participants through all the important aspects of taxable and nontaxable fringe benefits that will help them understand how to get this right. To gain insights into how to get taxable and nontaxable fringe benefits right, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501196LIVE?Linkedin-SEO

Learn about the taxable and nontaxable fringe benefits to avoid penalties

This webinar is highly useful for those who have some confusion about taxable and nontaxable fringe benefits. Since there are many items that are classified under both taxable and nontaxable fringe benefits; clarity on each of these will go a long way in helping to understand the correct method of filing.

The learning from this webinar is important also because not only are the wrong expenses may disallowed by the IRS; filing under the wrong classification could result in penalties, too. Greta will offer complete clarity on benefits that can be hid in Sections 274, 162, 119, 132, 127, and 82. She will also give an understanding of numerous Announcements, Notices and Regulations, all of which have to be assiduously adhered to.

In addition, she discuss a few areas of taxable and nontaxable fringe benefits that offer scope for ambiguity, such as:

o  What are taxable and non-taxable as wages?

o  Are meal allowances nontaxable?

o  Are travel allowances nontaxable?

o  What other benefits are nontaxable wages?

o  What meals are 100% deductible and nontaxable to employees?

o  What meals are 80% deductible and nontaxable to employees?

o  What meals and entertainment are 50% deductible and nontaxable to employees?

At this session, Greta will cover the following areas:

o      Which benefits go on the w-2?

o      Do any benefits go on a 1099?

o      Fringe benefits you might be missing

o      Accountable employee reimbursement plan

o      What employee benefits are non-taxable to employees?

o      What/when expenditures are wages to employees?

Fringe Benefit Examples and How They Relate to W2 and 1099 preparation:

o      Accountable vs non-Accountable Expense Reimbursement Plans

o      Record keeping requirements of Sec. 274 & Accountable Plans

o      50%, 80%, and 100% Deductible Meals

o      De Minimis fringe benefits

o      No added cost benefits

o      Cash payments

o      Auto allowances

o      Company vehicles

o      Prizes, awards, gifts

https://www.hr360.com/Employee-Benefits/Fringe-Benefits/Introduction-to-Fringe-Benefits.aspx

https://www.paychex.com/articles/finance/taxable-vs-nontaxable-fringe-benefits

http://smallbusiness.chron.com/list-nontaxable-fringe-benefits-21172.html

http://www.moneycrashers.com/taxable-fringe-benefits-income/

https://justworks.com/blog/ins-outs-fringe-benefits-non-taxable

International Financial Reporting Standards (IFRS) 6

The International Financial Reporting Standards (IFRS) standards are a set of standards pertaining to different industries and their activities and practices. IFRS 6 relates to guidance in the accounting practices of the extractive industries, such as oil, mining and gas. The IFRS 6 accounting standard states the requirements, as well as the disclosures that need to go into accounting practices for expenses that a company incurs during the course of exploring and evaluating expenditures.

Till the enactment of the IFRS 6, regulations on the accounting practices of the extractive industries were fragmented and piecemeal. The major change the IFRS 6 brought about it is that it consolidated these practices. Also, with the passage of IFRS 6, entities that were using accounting practices for exploration and evaluation assets that were in use prior to the enactment of the IFRS 6 could integrate these earlier practices with the provisions of the IFRS 6.

Core accounting requirements

One of its core requirements is that of the issuance of IFRS compliant financial statements by companies that have assets used for exploration and evaluation of mineral resources.

So, it is imperative for accounting professionals to have full knowledge of the IFRS 6. Working with the oil, mining or gas areas in companies that have assets that are used for exploration and valuation of mineral resources and being successful entails having to comply with the requirements set out by the IFRS 6.

A proper understanding of the IFRS 6

A learning session that is being organized by Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will offer the learning needed for getting trained on how to comply with the requirements set out in IFRS 6.

At this webinar, Mike Morley A Certified Public Accountant and business author who organizes various training programs, such as IFRS, SOX, and Financial Statement Analysis that focus on providing continuing education opportunities for finance and accounting professionals, will be the speaker.

Professionals who work in the oil, mining or gas areas in companies that have assets that are used for exploration and valuation of mineral resources can gain insights into what the IFRS 6 means for them by enrolling for this webinar. To register, please visit

http://www.compliance4all.com/control/w_product/~product_id=501194?Wordpress-SEO

Familiarization with all the aspects of the IFRS 6

The aim of this presentation is to help oil; mining and gas professionals become knowledgeable about the latest information about IFRS 6. The speaker will familiarize participants with the unique accounting and reporting issues, particularly in regards to the evaluation of assets, revenues and expenditures that professionals in the extractive industries, involved in the search for mineral resources, including oil, gas, minerals, and similar exhaustible resources face.

Accounting professionals who work in these industries, and who need in-depth understanding of the way the IFRS 6 is structured, and the ways in which they need to apply the standards in the right manner, such as Auditors, Accountants, Financial Managers, Financial Controllers, Company Executives, and anyone involved in the SOX compliance process, will benefit immensely from this webinar on the accounting practices set out by IFRS 6.

At this session on the IFRS 6, the speaker will cover the following areas:

o  Why the accounting for this sector is different

o  How resource assets are evaluated

o  Special rules for measuring revenues and expenditures

o  How revaluation rules apply to the Oil, Gas, and Mining industries

o  Other specific requirements of IFRS 6

o  Required disclosures.

http://www.accaglobal.com/in/en/student/exam-support-resources/dipifr-study-resources/technical-articles/ifrs6.html

http://www.icaew.com/en/library/subject-gateways/accounting-standards/ifrs/ifrs-6

https://www.iasplus.com/en/standards/ifrs/ifrs6

Analyzing financial statements is an indispensable insight for managers

Financial statements are the ultimate indicator of a company’s financial health. Number crunching is a very important exercise that all executives at all levels of an organization need to be familiar with. Yet, given the heavy jargon that goes into financial statements and the complexity most of them have; many managers feel put off and don’t generally like to pore over financial statements.

The company’s financial statement is intended to provide insights into the most important aspect of the business –the financial one –to managers and executives at all levels and in all disciplines. Marketing, finance, HR, customer service, and sales need financial statements to get a grasp of and gain perspective of the financial health of the organization.

Financial statements are critical for helping understand the business

Despite financial statements being the surest indicator of the most important aspect of any business organization –Finance –most managers lack the perceptiveness needed to understand and analyze the meaning of numbers. It is often that they devote some much time to running their business that the priority that needs to be accorded to understanding financial statements gets buried and takes a backseat.

A perceptive analysis of financial statements is the foundation to getting the business in order. Wading through the numbers helps the organization to dig into the market trends, understand where they are getting it right or wrong, and then use financial statements to draw proper conclusions and take appropriate action. It is important to understand financial statements for another critical reason: The competition should not understand our financial statements faster and better than we do!

Trend and ration analysis of financial statements

But how does one make sense of heaps and heaps of seemingly unintelligible numbers? Numbers in themselves, without the necessary nous to decipher them, make little sense to any executive. A few techniques do exist to help understand the meaning of numbers. An effective model for assessing the financial condition and results of operations of any business is that of using trend and ratio analysis. Getting a grasp of this model will empower financial and other executive teams to derive the maximum benefit that accrues from a crystal clear understanding of financial statements.

Imparting this understanding is the intent of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all areas of regulatory compliance. Miles Hutchinson, an experienced CGMA and business adviser, will be the speaker at this session.

In easily comprehensible terms, he will explain how participants can imbibe the sagacity needed to quickly and thoroughly analyze the financial condition and results of operations of any publicly traded company. All that is needed to gain this highly useful understanding of financial statements is to register for this webinar by logging on to

http://www.compliance4all.com/control/w_product/~product_id=501197LIVE?wordpress-SEO

Attending this highly useful session on financial statements gives Financial Executives, HR Managers, Accounting Managers, Department Managers, and Business Unit Managers the ability to discern numbers and help understand where these numbers lead the organization to.

These are the areas this webinar on financial statements will cover:

o  Review the components of the annual report of a prominent publicly traded company and learn how to use this wealth of information

o  Use the annual report to perform a fundamental financial analysis

o  Learn the various types of financial analysis and their purpose

o  Learn the key ratios to evaluate a company’s liquidity, leverage and operating performance

o  Identify the key benchmarks to help determine whether a company’s ratios are in line with competitors

o  Understand horizontal and vertical analysis and how they can be used to identify key trends

o  Bonus: receive our advanced excel hosted financial model complete with all ratios, horizontal and vertical analysis

o  Use our model to perform financial analysis on other company financial statements, including yours

o  Receive benchmark information to use in determining the quality of your analyses

Learn about resources available to perform comparative studies between companies in the same economic sector – even private companies.

How to implement 21 CFR Part 11, which is about Compliance for Electronic Records and Signatures?

How to implement 21 CFR Part 11, the regulatory guideline which deals with compliance for electronic records and signatures, is a challenge for professionals in the medical devices and pharmaceutical industries. The FDA has set out 21 CFR Part 11 to help the regulated industries that come under its purview to structure their business processes better, bring down turnaround time and reduce costs, and to establish standard procedures on how to implement 21 CFR Part 11.

Compliance with 21 CFR Part 11 is necessary for reasons that go beyond just ensuring IT security. It is also a solid and foolproof means to ensuring efficiency and economy of electronic records. 21 CFR Part 11 compliance for electronic records and signatures is also indispensable for ensuring patient safety. All these factors have led the FDA to require compliance with 21 CFR Part 11 electronic records and signatures.

Compliance with 21 CFR Part 11 is terribly tough, but mandatory

Compliance with 21 CFR Part 11, its good intentions notwithstanding, is quite complex. Companies that seek to transition to electronic records are hesitant and fearful of 21 CFR Part 11, because understanding how to implement 21 CFR Part 11very difficult and time consuming. It requires adherence to all the complex rules and protocols that the FDA has put in place. Entities that need to be compliant with 21 CFR Part 11 have to meet the requirements of the FDA which deal with data security and patient safety.

Yet, compliance with 21 CFR Part 11 is not optional. How does a company ensure implementation of 21 CFR Part 11 compliance for electronic records and signatures? What are the nitty-gritty and nuances of 21 CFR Part 11 implementation?

A webinar from Compliance4All

The specific ways of doing this will be imparted at a webinar being organized by Compliance4All, a reputable provider of professional trainings for all areas of regulatory compliance. Edwin Waldbusser, who has been consulting in the US and internationally in the areas of design control, risk analysis and software validation, will be the speaker at this webinar. To gain learning about 21 CFR Part 11 implementation, enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501132LIVE/~sel=LIVE/~Edwin_Waldbusser/~21_CFR_Part_11_-_Compliance_for_Electronic_Records_and_Signatures

The speaker will help participants get an understanding of what 21 CFR Part 11 is and why it is important for industries to comply with it. The most important learning this webinar will impart is that it will help participants remove the fear and anxiety associated with ensuring 21 CFR Part 11 compliance for electronic records and signatures. This learning will help them approach this vital activity with confidence, so that they will not become targets of 483’s and Warning Letters that result from noncompliance.

A major topic Edwin will take up at this webinar is the rather stringent and punitive nature of this regulation. 21 CFR Part 11 was considered so harsh when it was introduced that it forced the industries that come under it to altogether give up on transiting to electronic records. Such was the fear and awe it incited. When industry made a plea to the FDA on this aspect, the regulatory body refused to dilute the severity of the requirements, but only said that it would take up implementation selectively. The speaker will talk on this aspect of 21 CFR Part 11 compliance for electronic records and signatures.

He will cover the following areas at this webinar:

o  Company certification

o  Records covered

o  Audit trails

o  Open/closed system access rules

o  Electronic signatures

Training requirements.