The California Online Privacy Protection Act of 2003 or OPPA became effective on July 1, 2004, is a pioneering privacy law enacted by a state. It requires owners of commercial websites or online services to conspicuously post a privacy policy.
Applicability
OPPA applies to any website that collect personally identifiable information from California consumers.
OPPA does not apply to ISPs or similar entities that transmit such information at the request of third parties.
Google accused of OPPA non-compliance
In 2008, a New York Times reporter said in a blog post that Google might be violating OPPA since it hadn’t posted a link to its privacy policy from the homepage. Rather, the search engine’s privacy policy had been posted at the bottom of the About Google page.
Following this, privacy activists and groups sent the Google CEO a letter charging that "Google's reluctance to post a link to its privacy policy on its home page is alarming."
The company had argued that users could access its privacy policy by typing Google Privacy Policy in its search engine. A month and a barrage of criticism later, Google linked to its privacy policy from its homepage, fulfilling OPPA requirements
Monday, September 12, 2011
Wednesday, May 25, 2011
What is FMEA and How to Use it
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 FMEA allows analysis of the criticality of a failure, such an analysis is called FMECA or Failure Mode and Effects Criticality Analysis
Most medical device companies use FMECA, although they incorrectly label it as “FMEA”
Failure Modes and Effects Analysis was developed as a tool to explore the effects of failure of components on the reliability of various products.The tool was developed as a tool for use in the field of reliability engineering to explore where more rugged components would be required to obtain desired product life
The title of the standard, Analysis techniques for system reliability-Procedure for failure modes and effects analysis (FMEA), reflects its correct use
Use of FMEA
As an input to the Risk Management process FMEA should be used to:
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 FMEA allows analysis of the criticality of a failure, such an analysis is called FMECA or Failure Mode and Effects Criticality Analysis
Most medical device companies use FMECA, although they incorrectly label it as “FMEA”
Failure Modes and Effects Analysis was developed as a tool to explore the effects of failure of components on the reliability of various products.The tool was developed as a tool for use in the field of reliability engineering to explore where more rugged components would be required to obtain desired product life
The title of the standard, Analysis techniques for system reliability-Procedure for failure modes and effects analysis (FMEA), reflects its correct use
Use of FMEA
As an input to the Risk Management process FMEA should be used to:
Solvency II
Solvency II is a new, stronger EU-wide requirement on capital adequacy and risk management for insurers with the aim of increasing protection for policyholders. The strengthened regime should reduce the possibility of consumer loss or market disruption in insurance.
Solvency I was a minimum harmonization directive introduced in the early 1970s. It allowed for differences to emerge in the way that insurance regulation was applied across Europe leading to different regimes. It was also primarily focused on the prudential standards for insurers and did not include requirements for risk management and governance within firms.
Solvency II aims to achieve consistency across Europe on the key ideas of: - Market consistent balance sheets;
- Risk-based capital;
- Own risk and solvency assessment (ORSA);
- Senior management accountability; and
- Supervisory assessment.
The Solvency II Directive states that the new regime will go live on 1 November 2012 when it will replace the Solvency I requirements and the current regulatory regime for insurance supervision for firms in the UK. The European Commission’s (EC) proposals for the Omnibus II Directive include an amendment to the implementation date by two months to 1 January 2013.
The new regime will apply to all insurance firms with gross premium income exceeding €5m or gross technical provisions in excess of €25m. Some insurance firms will be out of scope depending on the amount of premiums they write, the value of technical provision or the type of business written.
Solvency II principles and rules apply to Lloyd’s of London syndicates in full. Due to its specific nature, some of the Solvency II requirements are being considered for their application to Lloyd’s.
European process
Solvency II is being created with a four-level process or the ‘Lamfalussy processes
Saturday, March 12, 2011
Process validation process
Following processes to be validated are
– Aseptic filling processes
– Sterilization processes
– Clean room ambient conditions
– Sterile packaging sealing processes
– Lyophilization process
– Heat treating processes
– Plating processes
– Plastic injection molding processes
– Routine end-product tests have insufficient sensitivity to verify the desired safety and efficacy of the finished devices
– Clinical or destructive testing would be required to show that the manufacturing process has produced the desired result or product
– Routine end-product tests do not reveal all variations in safety and efficacy that may occur in the finished devices
– The process capability is unknown, or it is suspected that the process is barely capable of meeting the device specifications
Process Validation steps
1. Determine the need to validate
2. Determine what to validate (IQ, OQ, or PQ)
3. Write a validation protocol
4. Conduct the protocol and collect the data
5. Analyze the data
6. Improve the process, as warranted, based on the data and analysis
7. Prepare a report
8. Maintain the documentation as a quality record
– Aseptic filling processes
– Sterilization processes
– Clean room ambient conditions
– Sterile packaging sealing processes
– Lyophilization process
– Heat treating processes
– Plating processes
– Plastic injection molding processes
– Routine end-product tests have insufficient sensitivity to verify the desired safety and efficacy of the finished devices
– Clinical or destructive testing would be required to show that the manufacturing process has produced the desired result or product
– Routine end-product tests do not reveal all variations in safety and efficacy that may occur in the finished devices
– The process capability is unknown, or it is suspected that the process is barely capable of meeting the device specifications
Process Validation steps
1. Determine the need to validate
2. Determine what to validate (IQ, OQ, or PQ)
3. Write a validation protocol
4. Conduct the protocol and collect the data
5. Analyze the data
6. Improve the process, as warranted, based on the data and analysis
7. Prepare a report
8. Maintain the documentation as a quality record
Types of Process Validation
Prospective
– Validation conducted prior to the distribution of either a new product, or product made under a revised manufacturing process, where the revisions may affect the product's characteristics.
There are three phases of prospective
validation:
– Installation qualification (Process equipment consistently operates within established limits and tolerances)
– Process performance qualification (The process is effective and reproducible)
– Product performance qualification (The finished product produced by a specified process meets all release requirements for functionality and safety)
Concurrent
– A subset of prospective validation conducted with the intention of ultimately distributing product manufactured during the validation study
Retrospective
– Validation of a process for a product already in distribution based upon accumulated production, testing and control data
In this validation there is an assumption, typically unmet, of complete records
– Customer complaints not investigated
– Investigations without adequate corrective action
– Scrap and rework not fully documented
– Inadequate process variability records
– Validation conducted prior to the distribution of either a new product, or product made under a revised manufacturing process, where the revisions may affect the product's characteristics.
There are three phases of prospective
validation:
– Installation qualification (Process equipment consistently operates within established limits and tolerances)
– Process performance qualification (The process is effective and reproducible)
– Product performance qualification (The finished product produced by a specified process meets all release requirements for functionality and safety)
Concurrent
– A subset of prospective validation conducted with the intention of ultimately distributing product manufactured during the validation study
Retrospective
– Validation of a process for a product already in distribution based upon accumulated production, testing and control data
In this validation there is an assumption, typically unmet, of complete records
– Customer complaints not investigated
– Investigations without adequate corrective action
– Scrap and rework not fully documented
– Inadequate process variability records
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