Compliance Resources to Help you Stay Current

The International Automotive Task Force (IATF) took on the challenge of developing a standard to harmonize three European catalogs-VDA 6.1 (Germany), AVSQ (Italy), EAQF (France)-and the North American QS-9000 standard. The result was the ISO/TS 16949:2002 standard. The Big Three automakers have put their support behind ISO/TS 16949:2002. QS-9000 is no longer in the long-term picture. According to an executive from one of the Big Three, the ISO/TS 16949 contains 90 percent of QS-9000 already, and it's an improved standard. DaimlerChrysler released a letter dated July 2002, which stated that effective July 1, 2004, all product and service part suppliers to DaimlerChrysler are required to be registered to ISO/TS 16949. In early August 2002, DaimlerChrysler, Ford and GM released a joint letter announcing that the third edition of QS-9000 will expire on Dec. 14, 2006, after which ISO/TS 16949:2002 will replace QS-9000

Airline safety is fast becoming increasingly complex and controversial. In recent times, discovering that critical safety checks had not been conducted on schedule, federal inspectors blew the whistle on Southwest Airlines, levying millions of US Dollars in fine from the airline company. In yet another instance, another major airlines in United States temporarily grounded dozens of Boeing 777s to test their cargo fire-suppression systems after a review of maintenance records showed a test on part of the system hadn't been performed. Such incidents have raised safety concerns amongst the airlines, the government and air travelers alike and there is a widespread awareness that safety inspections are serious business- they cannot be allowed to become haphazard

The Chief Audit Executive (CAE) and his team of internal auditors have a clear mandate - sharpen their focus on business risk and add value by being more risk-centric. Evolved from an objective assurance and consulting activity, IA will address the growing needs of global organizations and meet the new expectations of investors and board members.

Workplace Safety is emerging as one of the key risk management and regulatory compliance focus areas among many global companies. As a result of this trend, traditional workplace safety compliance systems, which were designed to be point solutions at a plant-level, are giving way to enterprise-wide safety management systems. Such systems need to comply with the OSHA 29CFR regulations and support the OSHAS 18001 framework, while providing enterprise-wide visibility into incidents and trends, corrective actions and process metrics. This paper highlights the requirements of next generation systems for workplace safety compliance.

During the past few years, the global finance industry has seen an unprecedented surge in regulatory requirements, forcing a greater focus on the way organizations manage risk, especially financial risk. Regulators and credit rating agencies are demanding more transparency. At the same time, stakeholders and senior management are pressing for enhanced business value. Most firms have typically created fragmented and silo-based risk management and control programs. These siloed risk management programs are, however, not scalable; the technology supporting them is insufficient; and they do not merge into a common framework.

FAA regulations on airline safety regulations has come under scrutiny after a deadly crash. The crash resulted due to formation of ice on the wings of teh aircraft. this has been a teething problem for long and agencies feel that FAA has taken way too long a time to act on this. Solution to this problem is going to be an expensive affair for the industry as they are already burdened with high safety costs after the terrorist attacks and the rising cost of aviation fuel. The need of the hour is to bring in proper de-icing regulations for the larger safety of the air travelers.

Last year has seen a spate of job losses owing to the economic situation across the globe. The ratio of job cuts to job created is hugely skewed. This has resulted in huge applications for the few jobs that are available. The sudden developments have left people at loss of ideas to deal with daily life. They are ending up venting their frustration by filing litigation againt their former employers if they find that the reason for lay-offs are not justified. Corporates who are already battling to keep their business afloat in these tough times are left with additional burden of handling grievances of their ex-employees. The articles speaks on how corporates can avoid this situation by way of methodically approaching any decisions concerning job cuts.

Availability of volunteers for clinical trials has always been a challenge. Uncertainity of the outcome has always been a deterant. More so in recent times researchers have been focussing on treatment for rare diseases. So this reduces the target population to a niche. So much of time is being invested in developing these drugs. But lack of volunteers is delaying the process of mass manufacture. Communicating the efficacy of such trials is also another challenge that these researchers face.

A strong risk management process along with project mangement can eliminate any surprises in the course of the project. It helps in a systematic and planned approach to risk mitigation than a knee-jerk reaction. Risk management involves a collective effort. It requires resources take time out of their actual project time. Everyone ahould be able to identify the potential risks associated with the project. The group further will consolidate on these risks identified and form subgroups to tackle these risks. Read more on the seven steps to risk management.

Risk management is the process of defining risk and developing mitigation strategies. Traditionally risk mangement has been focussing on risk arising out of physical and legal causes. Business have always practised risk management either for mally or informally. Risk Management starts with the source of problems or the problem itself. Once the problem is identified, assessment has to be thorough wit regards to the severity of loss caused by the problem. All risk management activities should be recorded and approved by appropriate level of management. Risk management is always an ongoing process and all plans must be reviewed and updated regularly.

USP has come out with a revised standard for labelling of ferrules and cap overseals of injectable drugs. This move has been made to help end users to see critical safety messages. The standard enforces the printing of safety messages on ferrules and cap overseals except were the message is clearly visible and has a visible contrast against the transparent cap overseal whichis legible under normal conditions of use. The standard restricts the location of other less important information which should be placed such a way that they don't interfere with safety messages. USP has come up with this standard after consultation with medical, nursing, pharmacy workers, industry representatives and FDA officials.

Ranbaxy has recalled its acne treatment drug Sotret for the second time owing to some descrepancy in the specifications. This is deemed as more of a voluntary and precutionary move as per the FDA class III procedure. In 2008, FDA had banned this drug owing to GMP deviations observed in Ranbaxy production plant in Himachal Pradesh. Ranbaxy was recently bought over by Japanese DaiiChi Sankyo who were surprised by the observation of filing untrue data by Ranbaxy with the FDA. Both the companies are cautious that this will not derail their ongoing efforts of reversing the ban in the US. Since the ban, the drug has lost heavily in the US market in terms of revenue.

A coordinated effort between the FDA’s Office of Criminal Investigation, Centre for Drug Evaluation and Research and Office of Regulatory Affairs resulted in issuance of 22 warning letters to operators of websites who were indulged in illegal sale of unapproved and misbranded drugs. With this internet service providers and domain name registrars will be able to terminate websites and domain name usage.

Noise above 80 decibels is considered potentially dangerous. Noise is a problem both within and outside work areas. Constant exposure to noise can lead to hearing loss and also other effects such as sleep loss, irritability, stress and loss of concentration.

OSHA has set up guidelines for admissible noise levels and mitigation of excessive noise. The 29 CFR standards 1910.95 have put down admissible noise exposure levels for different duration of exposure. The hearing conservation program has five parts

• Noise monitoring
• Audiometric testing
• Employee Training
• Hearing Protectors and
• Record Keeping

Compliance is a necessary evil. But knowing the high cost of non-compliance, it is a worth while effort to be compliant. Compliance augments brand value. It attracts new customers and helps maintain longstanding relationships with existing customers. Regulatory compliance works for the benefit of the society, protecting stakeholder interests. So, how do you prepare for it?

• Understand the implications of compliance on company health
• Communicate well with all involved
• Discovery – Research on the existing regulations
• Select the appropriate one for your type of industry
• Identify tools and vendors who can elevate efficiency

Sarbanes-Oxley is a tool to curb corporate scams and misreporting. The act enforces strong internal controls and transparency. The act is known for its tight deadlines, effective penalties and enforcement implications. Considering the sharp increase of financial scams and their intractability, SOX aims to keep a track of the company’s internal functioning patterns and information disclosure guidelines.

A lot is seen, read and heard about environmental change and climate change owing to the abuse we humans have meted out. A great deal of effort is being put into awareness, so that people adopt environment friendly measures. People are smarting up to the idea and are adopting fast.

Manufacturers are vying hard to cash in on this trend as the research made by Nielsen BASES and NMI have forecasted promising statistics with regards to the market. The paper goes on to identify the key highlights for marketers to retain:

1. The stage is set for many consumer packaged goods (CPG) categories to go green.
2. Green doesn’t have to be niche.
3. Extending an established brand equity may be the best bet.
4. Green/LOHAS products have a better chance of breaking through the clutter.
5. Getting beyond “niche” will require choosing and attracting the right target.
6. Getting the price right is a clear key to success.

More on green marketing strategies

Corporate Governance is earning limelight in the wake of collapse of many big wigs like the Enron, WorldCom and the recent Satyam. Though the compelling reason for such debacles has been improper financial reporting, it should be seen as a collective responsibility of all stakeholders.

Studies done on such incidents have unearthed other reasons like poor strategic decisions, expansions that are not justified or well thought of, greed and power lust of people at the helm of business, insufficient risk evaluation and mitigation plans.

More in detail on the actual factors that influence a governance failure read on

Business inception implies that all the intended goals are met and it has a successful run for a long-term. The top management or the Board of Directors has the responsibility of defining the intended vision and work towards the fulfillment of the vision. Clarity of definition means everybody in the organization is on the same platform and is committed to achieve the goals.

Further, the whole act should translate into adding economic value and sharing this commensurately with all the members. More on the underlying principles of corporate governance read on