Presenter Bio. Michael Hintz. Assessor/I.T. Professional, Shepherd Technical Services. 5+ years performing ISO/IEC 17025, TNI and DoD assessments
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2 Presenter Bio Michael Hintz Assessor/I.T. Professional, Shepherd Technical Services 5+ years performing ISO/IEC 17025, TNI and DoD assessments Accreditation Bodies: TCEQ, FL-DOH, MN-DOH, ANAB/L-A-B EPA D/W Certification Officer for microbiology, organic/inorganic chemistry 29 years in Information Systems & Technology Field Over 19 years in financial services industry Extensive focus on data security & regulatory compliance 20+ years designing and implementing data networks 15+ years designing, implementing and testing business continuance plans 10+ years performing data security audits and assessments
3 How Does This Apply To Me? Presentation
4 Why? Maintain Accreditation (TNI Standard:2003 / TNI Standard:2009 / DoD QSM v5) Laboratory shall retain all records for a minimum of 5 years or by contractual/regulatory obligation, whichever is longer. (includes all raw data bench sheets, logs, calibrations, original observations, etc. not just reports)
5 Why? Maintain Accreditation (TNI Standard:2003 / TNI Standard:2009 / DoD QSM v5) The laboratory shall have procedures to protect and back-up records stored electronically and to prevent unauthorized access to or amendment of these records. In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data. All records shall be held secure and in confidence.
6 Why? Maintain Accreditation (TNI Standard:2003 / TNI Standard:2009 / DoD QSM v5) Records that are stored only on electronic media shall be supported by the hardware and software necessary for their retrieval. What does that mean?! Think about YOUR environment... Are you running MS-DOS, Windows NT, Win 95, Win 98, Win XP? What version(s) of software/firmware are your instruments using? What version of your LIMS system were you using 4 years ago? Is it still supported?
7 Why? Protect the Employees (Livelihood) Protect the Customers (Data Custodian) Protect the Business (Reputation)
8 What? Data (plural noun, used with a sing. or plural verb) 1. Numerical or other information represented in a form suitable for processing by computer. 2. Factual information, especially information organized for analysis or used to reason or make decisions. 3. Values derived from scientific experiments. The American Heritage Dictionary of the English Language, Fourth Edition copyright 2000 by Houghton Mifflin Company.
9 What? Examples of Data: Final reports, raw analytical data, bench sheets Traceability data (log books) P.T. reports and supporting data Equipment calibration & configuration records Model numbers, software versions Purchasing records Customer and vendor contact information
10 Where Do I Begin? Security Mitigating Risk
11 Security - Mitigating Risk Physical Security Standards Controlled Access (locked rooms & file cabinets) DoD QSM v5: Physical access to the servers is limited by security measures such as locating the system within a secured facility or room, and/or utilizing cipher locks or key cards. Records storage environment (fire, flood, humidity) Confidential data protection (shred policy & process) Record retention (archiving policy & process ) Record destruction (purging policy & process )
12 Security - Mitigating Risk Logical Security Standards Controlled Access (unique passwords & password policy) DoD QSM v5: Individual usernames and passwords required, and must be changed at least once a year DoD QSM v5: Staff trained annually in computer security awareness Secured network (both wired & wireless) DoD QSM v5: Log-on/break-in attempts monitored; virus protection DoD QSM v5: Electronic data management system is protected from the introduction of computer viruses Records storage environment (disks, CD s, DVD s, the cloud ) Confidential data protection Record storage & transmission policy & process Record retention (archiving policy & process) Record destruction (purging policy & process)
13 Where Do I Begin? Disaster Planning/Business Continuance
14 Disaster Planning Mitigating Risk You can t prepare for EVERY possible risk, so Perform a risk assessment for YOUR laboratory Start by identifying top 2 or 3 disaster risks Examples: Fire Flood Hurricane Tornado Earthquake Florida 1. Hurricane 2. Flood 3. Fire 4. Tornado 5. Earthquake California 1. Earthquake 2. Fire 3. Hurricane 4. Tornado 5. Flood
15 Disaster Planning Mitigating Risk You can t prepare for EVERY possible risk, so Perform a risk assessment for YOUR laboratory Start by identifying top 2 or 3 disaster risks Gather knowledge Identify & involve subject matter experts (SME s) Delegate - each SME responsible for their area Encourage out of the box thinking
16 Disaster Planning Mitigating Risk You can t prepare for EVERY possible risk, so Perform a risk assessment for YOUR laboratory Start by identifying top 2 or 3 disaster risks Gather knowledge Start Planning Imagine each disaster scenario and document the steps you would take to recover Brainstorm independently AND as a group
17 Disaster Planning Mitigating Risk You can t prepare for EVERY possible risk, so Perform a risk assessment for YOUR laboratory Start by identifying top 2 or 3 disaster risks Gather knowledge Start Planning Think a step (or two, or three) ahead Identify and document remediation vendors Identify alternative work space Identify potential partnerships (reciprocal?)
18 Disaster Planning Mitigating Risk You can t prepare for EVERY possible risk, so Perform a risk assessment for YOUR laboratory Start by identifying top 2 or 3 disaster risks Gather knowledge Start Planning Think a step (or two, or three) ahead Review and TEST the plan then RE-test it annually Can you still buy/rent the equipment you need? Can you READ your backup data? (DoD QSM v5 requires it!) Is vendor list still accurate? Contact information current?
19 Disaster Planning Mitigating Risk You can t prepare for EVERY possible risk, so Perform a risk assessment for YOUR laboratory Start by identifying top 2 or 3 disaster risks Gather knowledge Start Planning Think a step (or two, or three) ahead Review and TEST the plan Re-evaluate your top risks
20 Disaster Planning Mitigating Risk You can t prepare for EVERY possible risk, so Perform a risk assessment for YOUR laboratory Start by identifying top 2 or 3 disaster risks Gather knowledge Start Planning Think a step (or two, or three) ahead Review and TEST the plan Re-evaluate your top risks All looks Good? Identify and plan for risk #4+
21 Disaster Planning Mitigating Risk Food for thought If you showed up at your lab tomorrow and it was gone, do you have the data you need to Contact your Accreditation Body? Contact your clients? Contact your vendors? Know where to begin the business continuance process?
22 Disaster Planning Real-World Examples Physical Damage - Hurricane Ike
23 Disaster Planning Real-World Examples Physical Damage - Hurricane Ike
24 Disaster Planning Real-World Examples Physical Damage - Hurricane Ike
25 Disaster Planning Real-World Examples Physical Damage - Hurricane Ike
26 Disaster Planning Real-World Examples Physical Damage - Hurricane Ivan
27 Disaster Planning Real-World Examples Physical Damage - Hurricane Ivan
28 Disaster Planning Real-World Examples Electrical Fire Damage Mechanical Room
29 Disaster Planning Real-World Examples Electrical Fire Damage Entire Lab
30 Disaster Planning Real-World Examples Logical Damage Virus/Malware Large multi-location laboratory Corporate computer network infected by malware (computer virus) Negatively impacted internal network Remediation took WEEKS Significant resource impact time AND money! Think about this in YOUR environment What if I can t access my LIMS? My instruments? My computer? What if I can t print reports? Send Invoices? Access client information? What do I do first? Second? Third?
31 Disaster Planning Real-World Examples Re-Defining Data Dump
32 Disaster Planning Real-World Examples Monitor Re-Defining Data Dump Server Server Server
33 Disaster Planning Real-World Examples Re-Defining Data Dump
34 Disaster Planning Real-World Examples Re-Defining Data Dump
35 ? Questions?
36 Thank you for attending! For additional information, contact Michael Hintz Shepherd Technical Services Phone: (512) ext Mike Shepherd Shepherd Technical Services Phone: (512)
37 MITIGATING RISK Disaster Recovery/Business Continuance Power Failure Contingency Uninterruptible Power Supplies on critical equipment Battery back-up on temperature sensors for refrigeration Electronic vs. Paper Records & Documentation Electronic archiving via offsite backups and/or cloud services
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