Document Control Bryanne Shaw Biology Section Manager Minnesota

Document Control Bryanne Shaw Biology Section Manager Minnesota Department of Agriculture 3/11/15 11: 00

MFRPS and Documents • Written procedures required for all 10 standards. • Written procedure required for the quality assurance program. • Standard 10 requires lab be accredited to ISO 17025: 2005 or have a quality assurance program that meets requirements in ISO 17025: 2005.

ISO 17025: 2005 and Document Control • “The laboratory shall document its policies, systems, programs, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results. The system’s documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel. ” • The laboratory shall establish and maintain procedures to control all documents that form part of its management system. (internally generated or from external sources)… • All documents issued to personnel in the laboratory as part of the management system shall be reviewed and approved for use by authorized personnel prior to issue. • Changes to documents shall be reviewed and approved by the same function that performed the original review unless specifically designated otherwise.

Disclaimer • I am speaking from my own lab’s experience, and are still grappling with some aspects of document control.

What is a document? • Can be internally authored, or it may be of external origin. • There can be many categories of documents in the management system. – regulations, standards, other normative documents, test and/or calibration methods, as well as specifications, instructions, manuals, policy statements, procedures, notices, memoranda, software, drawings, plans, etc. • They can be in various formats or media.

What does it mean to control a document? 1. Before a document is used, it must be reviewed and approved by someone who is authorized. 2. Issued and made available to those who need to know what’s in the document. 3. Must be identified so it can be kept track of. 4. If changes to the document are made, repeat the process, and get rid of the old version. Goal: Only approved documents are used; invalid and obsolete documents are not.

Approval and Issue • Approve for use. – Signing – You define who signs off or approves on a document (who and how many) • Uniquely Identified. – Document number, Date of issue and/or revision • Page numbering, including the total number of pages or a mark to signify the end of the document.

Document Master List • Current revision status and distribution. – Distribution list – hard copies and who has them so they can be retrieved when obsolete. • Preclude the use of invalid and /or obsolete documents.

What needs to be controlled? • Where do you draw the line for what needs controlled and what does not?

Internal Documents • • Standard Operating Procedures (SOP), Work Instructions (WI), Quality Manual Policies

Requests, Tenders, and Contracts • Contracts can be very different depending on the customer. – Internal – within agency – Internal – within state with other agencies – External – Federal • Information included in the contract may provide instruction to personnel.

Not so obvious • External Documents: – – – Manufacturer’s instructions, Equipment manuals, kit inserts, etc. Policies and instructions from accrediting body Standards (CFR) Customer procedures, instruction or memoranda FDA Investigations Operations Manual • Others to consider – Software • Anything else you are using as part of your quality management system (QMS)/Quality Assurance Program (QAP).

Some criteria / questions to ask yourself / ideas when trying to decide if an external document needs to be controlled…

Does an internal procedure refer you to the external document? Examples from some of our own Methods: • For further differential biochemical characters of Salmonella, refer to the Antigenic Formulae of the Salmonella Serovars, 9 th edition and BAM chapter 5. • Follow maintenance procedures in the Soxtec™ 2050 Automatic System User Manual, 2003. • Continue with analysis as directed by the BAX® User Guide and BAX® Ready Reference Guide. • Count the number of seedlings that exhibit sufficient growth of specific structures as described in the AOSA Rules for Testing Seeds, Volume 4, Seedling Evaluation: Fabaceae, Legume Family V – Small-seeded. • MS/MS maintenance and repair: cone cleaning, capillary replacement, mass spec cleaning, etc. is performed as needed (e. g. , change in response). Refer to the equipment manuals for troubleshooting instructions.

How you write your procedures can determine if a document is controlled Referenced in procedure vs • Instruction manual – used for writing your internal procedure but you never say “go to the manual” or “refer to the manual” then it’s a reference. (your internal procedure is all inclusive) Referred to in the procedure • Instruction manual – if in your procedure you say go to this manual for step -by-step guidance on how to do something – Control it.

Do you, or might you, use the external document in the course of your work to find instructions on how to do something?

Does it matter if it changes?

Can’t hurt, might help!

External Documents MDA controls § Instruction for making media from the manufacturer (when we haven’t written our own procedure) § Kit Inserts § Equipment manuals § A 2 LA Policies, forms and check lists § FDA Bacteriological Analytical Manual (BAM) Methods

Invalid or Obsolete Documents • Invalid documents may be from an outside source and have not been approved for use. • All copies of obsolete documents need to be removed from the system. – Maybe retained for legal or historical reference. Need to be marked that they are obsolete or retired.

Does your staff understand? • No photocopies. • Return old documents when a new revision is released. • Are they PACK RATS? – There's nothing wrong with holding onto old documents as reference or informational material when they become obsolete as long as they're properly marked as retired or obsolete.

Document Control • Document control may be a new concept to your personnel. • Training • Follow-up thru internal audits to make sure obsolete documents are not in use.

MDA’s long and winding road • Tracking documents on a 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” (Saa. S) Quality Management System solution (2013 and BEYOND!!!!)

MDA’s QMS Software Solution • Master. Control – Salt Lake City, UT • • Saa. S Web access Hosted Concurrent Licenses

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

MDA Laboratory Experience • We have transitioned from our home grown system to Master. Control. • Our SOPS, WIs, QAM and Lab Policies are in Master. Control. • We have also added External Documents that staff deemed part of the QMS. • We are currently in the process of adding equipment manuals.

Why did MDA decide to purchase a Quality Management System Saa. S solution for Document Control?

Documents and Training • Document control is really just half of the equation. Where there are documents, there are training requirements! • For every document that you are including in your document control system, you are going to train at least one person on that document, and in fact your entire staff may need to be trained on this document. • This connection of ensuring that everybody that needed to be trained on a document actually got trained proved to be a huge challenge for us. – We were trying to manage our training records in a spreadsheet that was separate from and did not talk to our document control system.

Documents and Training • We found that we had many documents for whom no one was trained. And other documents where training was done for some staff, but not all. – Someone was out of the office on the day of the training, and then someone forgot to follow up to make sure they got their training at a later date. • 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.

Documents and Training • We learned that documents and training are very interrelated. • If your document control system is managed differently than your training records and the two systems don't talk to each other, you are relying on a human being to monitor the hundreds of documents and thousands of training records that you need to maintain. • So 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.

“Go Live” – Documents Module • January 2014 • Imported 830 internally authored documents, including: – 93 SOPs – 160 Methods – 219 Work Instructions – 358 Forms

“Go Live” – Training Module • April – May 2014 – Master. Control identified ~4700 training tasks – Then imported ~3600 training records from legacy systems – Leaving ~1100 training tasks to be completed – Master. Control sent out the training tasks – No more training gaps

Quality Events • Quality events- nonconformances, deviations, customer complaints, audit findings, and so forth. • These events may require you to initiate a corrective action or preventive action (CAPA) process. • Root cause- to prevent it from recurring you are most likely going to have to revise one or more of your documents. – Revising a document needs to triggers training for everyone who has responsibility under that document.

Quality Events • Then you must monitor your corrective action to determine if it is effective. • Quality Management System (QMS) and Quality Event Management System (QEM) are also interrelated, and if these two systems are managed separately and don't talk to each other it becomes extremely difficult for a human being to manage all of this.

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

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. – Some people can keep track of it all in a spreadsheet or in a database of their own creation. • 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 clearly define how things work in your division and who is responsible for what.

Contact Information Bryanne Shaw Biology Section Manager Minnesota Department of Agriculture Email: bryanne. shaw@state. mn. us