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: Improper Practice Report
An analyst comes to the QAO and tells them that they witnessed another analyst not accurately recording information on bench sheets (this could be times, weights, or readouts from a meter). What now?
Investigate to identify root cause - why did this happen? Is workflow an issue? For how many other tests might this or other analysts have inaccurately recorded information? Review training records and individual/continuing demonstrations of competency. How many samples might have been affected? How was the issue identified? Pool data records, look for inconsistencies (too right, always perfect). Evaluate as an ethics situation, forming a team to do interviews.
The outcome of the investigation should identify analyst intent or other process issue. Once determined, it may be necessary to involve others such as: the data reviewer, Lab Manager, QAO, other 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.
Notify individuals performing internal audits. Document incident and corrective actions. Impose discipline if it is a data integrity issue. Add example to Ethics training. Address the process if it is workflow related. Fix/reevaluate samples affected, and issue amended reports.
Look at cross-training programs for use in the future. Obtain and review relevant documents. Conduct an internal audit with a follow up internal audit for later verification. Re-analyze samples if possible. Cancel tests if needed. Retraining for analyst(s) as needed. Initiate a Corrective Action/non-conformance.
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 & 2016 TNI V1M2 Rev. 2.1
4.0 Management Requirements §4.1.5
4.2 Management §4.2.1
4.2.8 Additional Management System Requirements
126.96.36.199 The laboratory shall establish and maintain a documented data integrity system… Management shall annually review data integrity procedures and update as needed.
a) Laboratory management shall provide a procedure for confidential reporting of data integrity issues in their laboratory….
b) In instances of ethical concern, the procedure shall include a process whereby laboratory management is to be informed of the need for any further detailed investigation.
4.9 Control of Nonconforming Environmental Testing Work (ISO/IEC 17025:2005, Clause 4.9) §4.9.1
4.11 Corrective Action (ISO/IEC 17025:2005(E), Clause 4.11) §4.11.1 thru 4.11.5
4.11.6 The laboratory shall have documented procedure(s) to address Sections 4.11.1 and 4.11.3 through 4.11.5….
4.13 Control of Record §188.8.131.52
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 …. The initial data integrity training and the annual refresher training shall have a signature attendance sheet or other form of documentation that demonstrates all staff have participated and understand their obligations related to data integrity…. At a minimum, the following topics and activities shall be included:
a) organizational mission and its relationship to the critical need for honesty and full disclosure in all analytical reporting, how and when to report data integrity issues, and record keeping;
b) training, including discussion regarding all data integrity procedures;
c) data integrity training documentation;
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….
NOTE: A problem with the management system or with the technical operations of the laboratory may be identified through a variety of activities, such as control of nonconforming work, internal or external audits, management reviews, and feedback from customers and from staff observations.
The procedure for corrective action shall start with an investigation to determine the root cause(s) of the problem….