Caribbean Public Health Laboratory (CARPHA), Port Of Spain, Trinidad And Tobago
CARPHA staff receiving Accreditation certificate from JANAAC. Left to right: Lisa Edghill, Quality Manager, CARPHA, Michael Tomlinson, Lead Assesor, JANAAC, Dr. Gabriel Escobar, CARPHA, Hepburn Wint, Technical Assessor, JANAAC
1. What was the hardest thing to do in order to get accredited?
- Getting the document control under control. It can be a challenge to get persons who have competing priorities to read and sign off documents.
- Making documents/SOPs more user-friendly; simplifying the documents
- Compiling documents to satisfy the accreditation application can be a tedious and daunting process
- Creating a culture of documentation – e.g., completing a non-conformity when something goes wrong. This was most challenging re equipment problems.
2. What was the easiest?
- Pre-assessments made the process of addressing Non Conforming Events easier.
3. What was the most important contributing factor to getting accredited?
- Having a decision-maker who is willing to be held accountable on behalf of the lab, particularly as it relates to establishing and meeting deadlines.
- Assistance from the CDC PEPFAR team with documentation as well as pre-assessment visits
4. What steps did you take?
It was a lengthy journey, however these were the key steps:
- Step 1 : Purchase the ISO Standard
- Step 2 : Designate a Quality Manager to lead the process
- Step 3 : Perform internal audits
- Step 4 : Determine the processes/procedures/forms to be developed, documented and implemented
- Step 5 : Develop a Document Control procedure
- Step 6 : Determine the scope of testing required to apply for accreditation
- Step 7 : Develop documents and implement procedures
- Step 8 : Conduct external assessments
- Step 9 : Address NCEs (PDCA)
5. What were the biggest mistakes you made?
- Seeking to develop the “perfect” procedure/process/form before implementing. More emphasis was placed on reviewing and revising documents and not implementing. It would have been more efficient to develop, implement, review and then revise.
- Too much emphasis was placed on having all the necessary documentation before implementing. In some instances, there is a need to develop and implement a process/procedure before formally documenting.
6. What is the best advice you can give to others?
- Don’t wait for the perfect procedure/document etc. Implement what you have – its only when you use the “documents” that you can determine what works best.
- Be realistic when determining the scope of tests for accreditation – It is better to start small, then once accredited, you can expand your scope.
- Ensure that members of staff are involved from the beginning so that they buy into and take ownership of the accreditation process. SLMTA training helps to communicate shared vision.
- Just do it! – Make a commitment to apply for accreditation and set a target date.