TNI Standards Guidance
Disclaimer: This material represents the opinion of its authors. It is intended solely as guidance and does not include any mandatory requirements except where such requirements are referenced. This guidance does not establish expectations of being implemented universally, exclusively, in whole, or in part.
This guidance does not establish or affect legal rights or obligations and is not finally determinative of the issues it addresses. It does not create any rights enforceable by any party in litigation with TNI, its accreditation bodies, or affiliated institutions. Any decisions made by TNI regarding requirements addressed in this guidance will be made by applying the applicable standards, policies or procedures to the relevant facts.
Module: Quality Systems
Subject: Manual Integration Misuse
During a review of an electronic monitoring report, curious activity of manual integrations was found where a failing QC became passing after manual integration. What actions need to happen?
Initial investigation hinges on whether there is a procedure for manual integration and if it was followed. Is this activity occurring with only one analyst or could other analysts be doing the same thing? It’s important to determine whether there is a training issue, if it’s just sloppy work or if there is a data integrity issue, because that answer will determine how best to address the problem.
Perform an investigation to determine intent. Once determined, it may be necessary to involve the data reviewer, Lab Manager, QAO, the Analyst(s) involved. Notify report reviewers and the client as appropriate. If it’s fraud, extent and impact will determine when to involve any of the following: AB, HR, lab owner, and/or legal counsel. It may become necessary to notify lab personnel, QA officer, and/or clients once investigation is completed. Notify AB as appropriate.
Perform Internal audit. Document incident and corrective actions. Impose discipline if it is a data integrity issue. Add example to Ethics training. Address instrument function—is it integrating appropriately? Have instrument serviced as needed. Fix/reevaluate samples affected, and issue amended reports.
Note: Careful consideration should be given prior to any action. Each circumstance should be viewed as unique. Investigations should be conducted quietly and with minimal involvement (limited only to those necessary to access crucial information). Not all suspicions result in demonstrated intent or malice. Quiet investigations preserve the integrity of an analyst who is wrongly accused. For a successful outcome, the approach must fit the issue(s) identified.
2009 TNI V1M2 and 2016 TNI Rev. 2.1 V1M2
4.0 Management Requirements §4.1.5 a, b, d, g, & h
4.2 Management §4.2.1
188.8.131.52 Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities, such as assessing data integrity, corrective actions, handling customer complaints, and all methods.
4.9 Control of Nonconforming Environmental Testing Work (ISO/IEC 17025:2005(E), Clause 4.9) §4.9.1 a, b, c, d, e and §4.9.2
4.11 Corrective Action (ISO/IEC 17025:2005(E), Clause 4.11) §4.11.1 thru 4.11.5
4.13 Control of Records §184.108.40.206
4.13.3 Additional Requirements
a) The laboratory shall establish a record keeping system that allows the history of the sample and associated data to be readily understood through the documentation… and
f) All information necessary for the historical reconstruction of data shall be maintained by the laboratory.
4.16 Data Integrity Investigations
All investigations resulting from data integrity issues should be conducted in a confidential manner until they are completed. These investigations shall be documented, as well as any notifications made to clients receiving any affected data.
5.2 Personnel (ISO/IEC 17025:2005, Clause 5.2) §5.2.1
5.2.7 Data Integrity Training
Data integrity training shall be provided as a formal part of new employee orientation and shall also be provided on an annual basis…. At a minimum, the following topics and activities shall be included: …
d) in-depth data monitoring and data integrity procedure documentation; and
e) specific examples of breaches of ethical behavior such as improper data manipulations, adjustments of instrument time-clocks, and inappropriate changes in concentrations of standards.
The data integrity procedures may also include written ethics agreements, examples of improper practices, examples of improper chromatographic manipulations, requirements for external ethics program training, and any external resources available to employees
5.10 Reporting the Results §5.10.9