Document Control. Bryanne Shaw Biology Section Manager Minnesota Department of Agriculture 4/11/19 09:00

Transcription

1 Document Control Bryanne Shaw Biology Section Manager Minnesota Department of Agriculture 4/11/19 09:00

2 MFRPS Standard 10: Documents Written procedure required for the quality assurance program Standard 10 requires lab be accredited to ISO or have a quality assurance program that meets requirements in ISO 17025

3 ISO 17025:2017 and Document Control Laboratory management shall establish, document and maintain policies and objectives for the fulfilment of the purposes of this document and shall ensure that the policies and objectives are acknowledged and implemented at all levels of the laboratory organization The laboratory shall control the documents (internal and external) that relate to the fulfilment of this document

4 ISO 17025:2017 and Document Control The laboratory shall ensure that: Documents are approved for adequacy prior to issue by authorized personnel Documents are periodically reviewed and updated as necessary Changes and the current revision status of documents are identified Relevant versions of applicable documents are available at points of use and where necessary their distribution is controlled Documents are uniquely identified The unintended use of obsolete documents is prevented and suitable identification is applied to them if they are retained for any purpose

5 MDA s long and winding road Tracking documents on an excel spreadsheet (1996) Developed an in-house repository called the lab document system (2006) Lab accreditation (2011) Moved to a commercial Software as a Service (SaaS) Quality Management System solution (2013)

6 MDA s QMS Software Solution MasterControl Salt Lake City, UT SaaS Web access Hosted Concurrent Licenses

7 MasterControl All Access Accident & Injury Audit Bill of Materials (BOM) CAPA Change Control Classes Customer Complaints Copies Deviations Document Collections Documents emdr Equipment Calibration Equipment Maintenance Event Analyzer Exams Guest Connect HR Finance Incident Meeting Notes Nonconformance Out of Specification (OOS) Process Projects Risk Risk Analysis Rules Supplier Supplier Deviation Training Variance

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11 Paper Copy Distribution Records

12 Training Documentation

13 Reports

14 Why did MDA decide to purchase a Quality Management System SaaS solution for Document Control?

15 ISO Audit Deficiencies Obsolete A2LA document found Master List missing A2LA documents Multiple missing training records

16 Documents=Training Document control is really just half of the equation. Where there are documents, there are training requirements! This connection of ensuring everybody needing to be trained on a document actually got trained proved to be a huge challenge We were trying to manage our training records in a spreadsheet that was separate from and did not talk to our document control system

17 Documents=Training We found we had some documents for which no training was documented and other documents where training was documented for some staff, but not all We were constantly faced with these gaps in training records and we got audit deficiencies related to training but we could never quite solve the problem

18 Documents=Training We learned documents and training are very interrelated If your document control system is managed differently than your training records and the two systems aren t linked, you are relying on a person to monitor the hundreds of documents and thousands of training records This was a big factor in our decision to move to a commercial product that links documents to training and allows us to automatically and electronically assign training tasks to staff

19 QEM Quality Event Inputs Nonconformances Deviations Complaints Audit Findings, etc. QMS Documents Issue Review/CAPA Process Risk Analysis Investigation Corrective/Preventive Actions Effectiveness Checks Training

20 In the End QMS software solutions may not be the right choice for everyone As your quality program grows and matures it may become increasingly difficult to manually manage MDA decided that a commercial product was the way to go Regardless of the system that you have to control your documents you must first have procedures in place that that clearly define how things work in your division and who is responsible for what

21 Contact Information Bryanne Shaw Biology Section Manager Minnesota Department of Agriculture