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GaryCheung

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Everything posted by GaryCheung

  1. MHRA want "buffered core temperature" but this seems to be being interpreted as "simulated product" from what recently inspected sites are saying. Whether this is MUST or SHOULD I don't know. I don't know whether MHRA have picked up on paedi packs in this regard yet. One site chose 100 ml water in an adult pack as a compromise, others are talking about adult and paedi pack simulated product into which probes are inserted. Obviously, monitoring air temperature gives you earlier warning, but some systems allow alarm delay and door open events to be recorded anyway and the MHRA line seems to be Alarm linits = 2-6C (water); 2-8C air
  2. We use 8D for higher severity incidents/non-compliances. Qpulse has an 8D template installed as standard & it has a few sub-stages within the ones you list above. within 3 there is a stage to Validate that Actions identified actually worked (the idea being to require someone to sign off the containment actions have done their job before moving on to the next stage) Within 4 RCA there are: Analyse and Identify tools for investigation (e.g. 5 whys, fishbone etc - the thinking being that some tools suit some problems better than others) Generate Action Plan (i.e. the QM's Action Plan that deals with root causes) Instead of 5 (Verify CAs) the template has Identify Corrective Action with instruction to "Document and verify Permanent Corrective Actions" (this is the bit where responsible manager's decide how to translate the QM's Action Plan into a real local plan with responsiblities, time-scales & mechanisms for measuring success. I have altered 7 to Preventive Action (to keep CPA happy) with sub action "Identify similar systems with the potential for the same defect." (i.e. a Lessons Learned communication to other areas or identification of similar systems within the same area). I'm told that it is actually Stage 1 that is supposed to make the difference with the 8D approach. The rationale being that you need to involve all stakeholders at the very start to get buy-in for subsequent proposed changes & actions and to capture suggestions for improvement from as wide a group as possible, but particularly from within the staff group who are actually performing the procedure/process.
  3. What do you use in blood packs/containers that you are using to simulate product when monitoring blood fridges: water or a glycerol solution? If glycerol, what concentration and why? Has anyone had advice/rationale from MHRA or any other body on what to use? Do you add preservative (e.g. azide) & have any manufacturers offered advice on liquids vis a vis corrosion of probes?
  4. Me too please - may be able to exchange others
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