Transcript Document

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
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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:
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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, 9th 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
 A2LA 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” (SaaS) Quality Management System
solution (2013 and BEYOND!!!!)
MDA’s QMS Software Solution
• MasterControl – Salt Lake City, UT
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SaaS
Web access
Hosted
Concurrent Licenses
MasterControl All Access
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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
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Guest Connect
HR Finance
Incident
Meeting Notes
Nonconformance
Out of Specification (OOS)
Process
Projects
Risk
Risk Analysis
Rules
Supplier
Supplier Deviation
Training
Variance
MDA Laboratory Experience
• We have transitioned from our home grown
system to MasterControl.
• Our SOPS, WIs, QAM and Lab Policies are in
MasterControl.
• 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
SaaS 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
– MasterControl identified ~4700 training tasks
– Then imported ~3600 training records from
legacy systems
– Leaving ~1100 training tasks to be completed
– MasterControl 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
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: [email protected]