STDUFFY626

The AABB has Assessment Guidelines which detail how they inspect a facility and what they expect to see. They will even offer Assessor training. You can review the material and then set up your Audit Schedule. Also, check out www.asq.org for the American Society for Quality. They literally have all kinds of information on auditing including certification of individuals as auditors. You need to research first then develop the Audit Plan that will work for your blood bank with the staffing that you have. Start small and slow and then build would be my best suggestion. Audit of compliance to your existing SOP's is a great starting point.

I believe John has the best idea. Let the Techs come up with "their scheduling plan" to cover the 7 day week and they will make it work. I've seen management structured plans, well thought out, just collapse when implemented because management could not think of the most important items that staff considered important. And you will be surprised at the ideas the Techs will come up with.

Our cGMP training is offered through scheduled classes for the first 3 quarters of the year and online training which covers the exact same material as in the classes. It is overseen by QA and has been made a mandatory reqirement for all job descriptions from our CEO on down the line to all staff. The benefits have been employees who have non technical jobs become additional eyes and ears in reconizing problems before they become crisis situations.

SINCE YOU ARE IN THE UK PERHAPS THE Medicines and Healthcare products Regulatory Agency WEBSITE MAY BE OF MORE USE TO YOU. www.mhra.gov.uk. THEIR STANDARDS, WHICH CAN BE VIEWED AND I BELIEVE DOWNLOADED, WILL ALSO DETAIL WHAT THEY EXPECT TO SEE IN A QUALITY MANUAL DURING AN INSPECTION. Steve.

Our SOP'S state that we observe universal precautions when handling all products and consider gloves as part of personal protective equipment (PPE). Is it possible that the inspector is citing you for something related to an sop statement or posted/approved work note and not necssarily a regulation?

We switched from rees to isensix about two years ago to to poor feild service by rees in our area when we needed them. Also, problems kept happening over and over. We are all extremely happy with the "isensix arms system".