Dealing with Deviations“Deviation” is the term used for a discrepancy between two sources of information.Observing, recording, and resolving deviations is a key part of the work of validationprofessionals. As such, you’ll encounter them and learn how to deal with them within thismodule. We’ve deliberately included a few deviations to test your awareness of this – … Continue reading “Dealing with Deviations | My Assignment Tutor”
Dealing with Deviations“Deviation” is the term used for a discrepancy between two sources of information.Observing, recording, and resolving deviations is a key part of the work of validationprofessionals. As such, you’ll encounter them and learn how to deal with them within thismodule. We’ve deliberately included a few deviations to test your awareness of this – attentionto detail is a key skill for validation personnel.The deviations you’ll be faced with in this module are when 2 documents show different valuesfor the same thing (e.g. the Piping and Instrumentation Diagram “P&ID” states a manufacturerfor a piece of equipment, and the equipment list states a different manufacturer). These areclassed as Category 1 deviations – typographic errors.In a real-world validation project, a deviation leads to several points of action (including fillingout specific deviation documentation). The specific actions you need to take if you notice adeviation will change on a project by project basis, depending what the deviation is, anddepending on your role in the team.It’s always important that you familiarise yourself with your responsibilities in each project’sprocedure.For the purposes of this module (and the assignment), we’re going to assume that dataon individual lists (e.g. instrument list, equipment list, etc) supersedes the P&ID.The procedure to follow for workshops in this module will be to assume that all you’d have todo is notify a supervisor (since you won’t have the relevant deviation documents in theworkshop):● Fill in the check sheet using the superseding data (i.e. the data on the instrument list,equipment list, etc. supersedes the P&ID)● Note the deviation in the comments section of the relevant check sheet – be sure to noteyour “actions” (naming the person you reported to)● Sign and date that note in the comment sectionIt’s worth noting that there are no protocols/standardization for the words you use when makingthese notes. But keep a couple of things in mind:● Use clear language – anyone should be able to understand the point using just what’swritten in the box. Someone shouldn’t have to come and ask you about it to fully “get”what you mean, and you should know exactly what you meant – even years later.● Write in a way that would be easily understood at any point in the future. Keep in mindthat this documentation might be revisited in audit several years from now.The procedure to follow for the assignment in this module will be:● Follow the steps outlined above for the workshops● In addition, make a note of the deviations as you find them, in Protocol Section 16.4 –Appendix D: Deviation Log● For each entry into Appendix D: Deviation Log, complete a separate Deviation Form(Appendix E)Since all deviations in our example system will be Category 1 – none will require you tocomplete the Change Control Log (Appendix F) or a Change Control Form (Appendix G).
