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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 & Chemistry


Subject: Improper Calibration Curve Change

Question 1

Data review indicates that an analyst has inserted the CCV from the current run back into the calibration curve to make the data pass. Further review indicates that this is not an isolated incident. What steps should the lab take?

Initiate corrective action. Involve the Lab Manager, Technical Director, QAO, and Supervisor.  Determine the time frame in which the incidents occurred and whether the malpractice is isolated to the one individual.  Establish whether it was intentional or due to unclear procedure (essentially, was it ethics or ignorance?).  Review analyst training. Identify which data were affected and how much of it was impacted? Was the analyst pressured to ensure that results were within regulatory limits? 
Re-analyze samples depending on availability and hold time. Recalculate all data, revise and re-issue reports.
Notify the impacted clients as well as regulators to whom data are reported or other data users.

If warranted, involve HR and the legal department. Depending on results of investigation, the analyst may be terminated.


References:

2009 TNI V1M2 and 2016 TNI Rev. 2.1 V1M2
EL-V1M4 2009

EL-V1M4-2016-Rev 2.2

2009 TNI V1M2 and 2016 TNI Rev. 2.1 V1M2

4.0 Management Requirements, 4.1.5 a, b and d

4.2 Management, 4.2.1

4.2.8.5 Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities.

4.9 Control of Nonconforming Environmental Testing Work (ISO/IEC 17025:2005(E), Clause 4.9), 4.9.1-4.9.2

4.11 Corrective Action (ISO/IEC 17025:2005(E), Clause 4.11), 4.11.1 4.11.5

4.13 Control of Records, 4.13.2.1 and 4.13.3 a and f(i)

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 for all current employees. Employees are required to understand that any infractions of the laboratory data integrity procedures shall result in a detailed investigation that could lead to very serious consequences including immediate termination, debarment or civil/criminal prosecution. 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.

5.5. Calibration Requirements, 5.5.10

5.9.3 Essential Quality Control Procedures
a) All laboratories shall have detailed written protocols in place to monitor the following quality controls: iii.) measures to assure the accuracy of the method including calibration and/or continuing calibrations, use of certified reference materials, proficiency test samples, or other measures

EL-V1M4 2009

1.7 Technical Requirements

1.7.1 Initial Calibration

1.7.1.1 Instrument Calibration
The following items are essential elements of initial instrument calibration:
a) the details of the initial instrument calibration procedures including calculations, integrations acceptance criteria and associated statistics shall be included or referenced in the method SOP.
c) sample results shall be quantitated from the initial instrument calibration and may not be quantitated from any continuing instrument calibration verification unless otherwise required by regulation, method, or program.

1.7.2 Continuing Calibration
When an initial instrument calibration is not performed on the day of analysis, the validity of the initial calibration shall be verified prior to sample analyses by a continuing instrument calibration verification with each analytical batch. The following items are essential elements of continuing instrument calibration verification.
a) The details of the continuing instrument calibration procedure, calculations and associated statistics shall be included or referenced in the method SOP.
d) Sufficient raw data records shall be retained to permit reconstruction of the continuing instrument calibration verification.
e) Criteria for the acceptance of a continuing instrument calibration verification shall be established.

EL-V1M4-2016-Rev 2.2

1.7 Technical Requirements

1.7.1.1 Initial Calibration
Samples shall be associated with an acceptable initial calibration. If the initial calibration is not acceptable, corrective actions shall be performed and all associated samples re-analyzed. The following items are essential elements of initial calibration:
a) the details of the initial calibration procedures including calculations, integrations, acceptance criteria, and associated statistics shall be included or referenced in the method SOP.
b) sufficient raw data records shall be retained to permit reconstruction of the initial calibration;
c) the laboratory shall use the most recent initial calibration analyzed prior to the analytical batch, unless otherwise specified by the method;

1.7.1.2 Continuing Calibration Verification (CCV)
e) . Continuing calibration verification records shall explicitly connect the continuing calibration verification data to the initial calibration.
i) sample results shall be quantitated from the initial calibration and may not be quantitated from any continuing calibration verification.