Posts

Showing posts from December, 2021

The Flight Delight – AS 9100 and AS 9110 By Anjalika Singh Vice President, QMII

  When I think of something sweet to eat, I think of Turkish Delight. It has dates, pistachios, hazelnuts, walnuts, and what makes it tasty are starch and sugar. When I think of flying, I assume that it would desire it’s two main delights – AS 9100 and AS 9110. Somehow, these two get sidelined and somewhere it’s ignored, and something goes amiss leading to an airplane’s malfunction, failure and worse, crash.   I oversee admin and sales at QMII. We sell lots of courses and have to be confident in knowing what we are selling and what training we are coordinating for with the students who have enrolled. Most of them are for AS 9100 Rev D and AS 9110 Rev C. The most common question that I am asked about is “what is the difference between AS 9100 and AS 9110?” Also, “if I do one of them like AS 9100 or AS 9110, is the other one taken care of on it’s?   The answer to the first question – There’s a difference between AS 9100 and AS 9110.   The answer to the se...

Subchapter M and crew safety

  The towing industry has gone many years without regulation. The need for safety management systems aboard tow boats especially those operating on the inland rivers has been known for some time. Many incidents that resulted in damage to the marine environment and loss of life drive the publication of subchapter M . The regulation ushers in a new era for tow boat safety and for those working abord the vessels. There is a greater responsibility of operators to maintain the vessels better as also to conduct periodic maintenance of equipment to ensure they are operating as needed. In addition, subchapter M 46CFR Subpart D places the requirements for crew safety. These requirements include the following: 1.        Personnel Records – The master of the vessel to keep an accurate list of crew members aboard as also their responsibilities. In addition, a record in the vessel’s logbook of the watchkeepers and the date time at which they assumed a week a...

How to write a value- adding nonconformity statement

  Much auditee time and money is wasted chasing auditor comments and recommendations often in the guise of nonconformity statements or observations.   So, as part of our auditor improvement service we are offering this elearning course free of charge.   Study this and you will be able to: Explain the value of a nonconformity statement Describe the parts of a nonconformity statement Write effective nonconformity statements Categorize nonconformities Initiate effective corrective action   * Well-crafted nonconformity statements help companies remove the root causes of costly problems.    Each nonconformity statement has three parts.   You can learn how to write each part so together the statement defines the problem clearly for the corrective action or problem solving team.    You can also learn how to weigh-up the magnitude of the nonconformity.   Definitions Nonconformity Nonfulfillment of a requirement Finding (used to be an ...

ISO 13485 and 21 CFR 820

  The quality needed of a medical device is perhaps equal to if not more that that required in aerospace. As ISO 13485training will identify, the standard is built upon the framework of ISO 9001. Medical devices need to be precision made taking into account the various potential risks and building controls within the manufacturing process to mitigate these risks. Non-conformities can be fatal resulting in the loss of a human life. ISO 13485:2016 is the most current version of the quality management system specifically for medical devices. Organizations that manufacture medical devices are required to comply with national legislation as applicable and in addition choose to be certified to ISO 13485 , a voluntary standard. Manufacturers, laboratories, hospitals and universities certify to this internationally recognized standard to demonstrate a commitment to quality products/services as also to demonstrate to stakeholders a commitment to continual improvement. Companies use this...