Failure Modes and Effects Analysis is the subject of an international standard, IEC 60812-Analysis techniques for system reliability-Procedure for failure mode and effects analysis (FMEA) The only international standard that applies for FMEA is IEC 60812, which shows general application, but does not show the use of the tool in risk management.An extension to the Read more about What is FMEA and How to Use it ?[…]
Be specific, truthful, unbiased and scientific Avoid Public responses Keep private response specific to the question Make sure the persons responding on behalf of you are medical or scientific personnel Make sure sales and marketing personnel are not involved at all even in training and awareness Makes sure you are keeping record of all the Read more about Dos and Don’ts of responding to Unsoliciated offlabel requests[…]
Q – Is it mandatory to have system requirements should be high level and functional specifications be detailed ? Ans – There is no specifically defined procedure for validation. Different process and terminologies comes under validation. Instead of using different terms like functional requirements, user requirements, functional specs, user specs, design specs, configuration specs, IT Read more about Expert Q&A – in computer system validation[…]
Due to COVID-19 many employers has adopted work from home set up for their employees. But as it is not the typical employer premises i.e work environment or the big circle around work environment where we define work related cases to record, it becomes difficult to know what to do when an employee reports an Read more about OSHA Recordkeeping for Work from home cases[…]
What is Just In Time or JIT ? The just-in-time (JIT) inventory system is a management strategy that aligns raw-material orders from suppliers directly with production schedules. This is driven by management philosophy of continuous and forced problem solving by using less input to get maximum output and by decreasing the waste in resources due Read more about Just In Time (JIT) Principles[…]
5S began as part of the Toyota Production System (TPS), which aims at increasing the value of products or services by finding and eliminating waste from production process. Why 5S is adopted ? To eliminate the wastes that result from “uncontrolled” processes. To gain control on equipment, material & inventory placement and position. Apply Control Techniques Read more about 5 Elements of 5S[…]
One after other drug manufacturing units of India getting warning letters or getting banned to manufacture licenses getting cancelled. Is this a systematic fight back (to the set back of patent disputes in favor of local generic manufacturers) by big pharma by their arm twisting techniques or is it real the plants are not following procedures. Today Hospira’s manufacturing unit in Read more about FDA warning Indian drug manufacturing units – Is it a retaliation to court ruling against Novartis[…]
Typically when an employer has violated any rules or standards related to OSHA , OSHA sends a citation and proposed penalty by registered email and it is must for the employer to put the copy of citation at the place of violation for at least 3 days or until the violation is rectified. Below are Read more about Schedule of Penalties by OSHA[…]
The laws against sexual harassment, a form of sex discrimination, are included in Title VII of the Civil Rights Act of 1964, which applies to: employers with 15 or more employees, including state and local governments, employment agencies, labor organizations, the federal government. The following types of behavior/conduct would be classified as sexual harassment Unwelcome sexual advance Requests Read more about Handling Workplace Sexual Harassment Complaints – 5 Best Practices to follow[…]
In 1970, the Currency and Foreign Transactions Reporting Act was passed by US Congress. It is commonly known as the Bank Secrecy Act or BSA. The Act requires US financial institutions to assist US government agencies in detecting and preventing money laundering.Specifically, the BSA requires financial institutions to: Keep records of cash purchases of negotiable Read more about The Bank Secrecy Act – What It Enforces ? Best Practices how to comply ?[…]