Laboratory Quality Assurance Activities Plan (Proficiency Testing)

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1.0 Objective and Purpose 
 1.1 The objective of the Quality Assurance Activities process is to monitor the validity of
 testing results, uncover potential errors or oversights, and learn where process and
 
 technical skill improvements may be made. 
 
 1.2 The purpose of this procedure is to describe how quality assurance activities are
 planned, to provide guidance for the activities used, to verify the validity of test results,
 and initiate action as a result of quality assurance activities. 
 
 2.0 Responsibility and Applicability 
 
 2.1 This procedure applies to testing activities performed within scope of accredited tests
 for Ion Labs. 
 
 2.2 QC Laboratory Management is responsible for determining the types of activities used
 to validate test data results and the accuracy of lab practices, for establishing,
 
 maintaining and updating a schedule of when and how such activities will be performed
 and for executing the planned activities. 
 
 2.3. QC Laboratory Management is also responsible for responding appropriately when the
 analysis results indicate that test data is suspect or inaccurate. QC Laboratory
 Management is responsible for ensuring that appropriate actions are taken including
 
 notifying customers, initiating report recalls and taking appropriate corrective action in
 accordance with the Nonconformity and Corrective Action procedure.
 
 2.4 QC Laboratory Management is responsible for ensuring that this procedure is accurate,
 understood and implemented effectively. No changes may be made to this procedure
 without the authorization of QC Laboratory Management. 
 
 3.0 Definitions 
 
 3.1 Proficiency Test- An Inter-laboratory comparison that is formally organized and managed
 by an independent third party. Additionally, the proficiency test includes the participation
 of a reference laboratory and uses the results to determine participant performance. An
 
 
 

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 (Proficiency Testing) 
 
 acceptable level of variation is determined. The results are then statistically compared.
 Values exceeding the acceptable threshold require the Lab to investigate their practice(s)
 and calculations to find the source of the test method, data analysis and/or measurement
 
 error. 
 
 3.2 Inter-laboratory comparison- the organization, performance, and evaluation of
 measurements or tests on the same or similar items by two or more laboratories or
 inspection bodies in accordance with predetermined conditions. The results are issued in a
 formal report. 
 3.3 Intra-laboratory comparison- conducted when several analysts or technicians within an
 organization perform testing or calibrations on the same or similar artifact, using the same
 
 method, under specified, controlled conditions. 
 
 3.4 Blind Sample- A sample submitted for analysis whose composition is known to the
 submitter but unknown to the analyst. 
 3.5 Intermediate Checks- checks performed to maintain confidence in the calibration status of
 measuring and test equipment. 
 
 3.6 Working standard- (In-house or secondary standard) is a standard that is qualified against
 and used instead of the reference standard. 
 
 3.7 Reference Material- controls or standards used to check the quality and metrological
 traceability of products. 
 4.0 References 
 
 4.1 C-502, SOP, Record Storage, Retention, and Destruction 
 
 4.2 C-501, SOP, Document Control Procedure 
 
 4.3 QS-108, SOP, Corrective and Preventative Action 
 
 4.4 A-113, SOP, Training Procedure 
 
 4.5 D-118-F1, Form, Quality Assurance Activities Schedule and Results 
 
 5.0 General 
 
 5.1 The Lab monitors its performance by comparison with results of other laboratories,
 where available and appropriate. This monitoring is planned (see section 5.1 below)
 and reviewed (see section 5.3 below) and includes participation in proficiency testing
 
 and/or participation in interlaboratory comparisons other than proficiency testing. The
 results of the monitoring activities are analyzed and used to control and if applicable,
 improve the Lab’s activities. 
 
 
 

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 5.2. External testing labs used to participate in interlaboratory comparisons or proficiency
 testing service providers will have been approved in accordance with the Purchasing
 and General Receiving procedure. 
 
 5.3 For any type of method selected, valid statistical analysis will be performed to
 
 determine the acceptability of the results. 
 
 6.0 Process Inputs 
 
 6.1 The inputs to the process include, but are not limited to the following:
 
 6.1.1 Test services performed 
 
 6.1.2 Validity of test results resulting from interlaboratory and Proficiency test
 requirements 
 
 6.1.3 ISO 17025:2017 requirements for validating test results 
 
 7.0 Process 
 
 7.1 Planning 
 
 7.1.1 Lab Management establishes a schedule to include at least one Quality
 
 Assurance Activity for each Lab Personnel identified as competent to perform
 accredited tests per year. Quality Assurance Activities are planned when the
 issuing body revises standard test methods to verify the laboratory can properly
 perform the method in light of the revisions made. Activities may be performed
 
 more frequently at the discretion of Lab Management. 
 
 7.1.2 The Quality Assurance Activities Schedule and Results spreadsheet is used to
 plan the activities, to identify the method used, to record the results, and to
 evaluate the results. The activities may be planned year-by-year or for several
 years in advance at Lab Management’s discretion. 
 
 7.1.3 External services are procured in accordance with the Purchasing and Receiving
 
 procedure. 
 
 7.1.4 Proficiency testing activities are planned where appropriate. The plan is
 included with all other quality assurance activities and documented on the
 Schedule and Results worksheet. Lab Management ensures proficiency testing
 includes the personnel who participate in accredited testing.
 
 
 

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 7.1.4.1 Where possible, customers’ samples are not used in inter-laboratory
 comparisons or proficiency testing. If customers’ samples are used,
 care will be taken to ensure that the samples are handled, stored, and
 transported to prevent damage or deterioration, and that customer data
 
 remains confidential. It is preferred that customers grant permission in
 writing prior to the use of their sample(s) for quality control activities.
 
 7.1.4.2 An acceptable level of variation is determined during the proficiency
 testing process. The results are then compared using valid statistical
 analysis to identify valid results and outlier results. Values exceeding
 
 the acceptable threshold require the participating laboratory to
 investigate their practice(s) and calculations to find the source of the
 test method, data analysis, and/or measurement error. 
 
 7.1.5 When the laboratory has decided to participate in a proficiency test, the ISO
 17025 accreditation body will be contacted upon achieving the following
 
 milestones: 
 
 7.1.5.1 When applying to participate in the proficiency test 
 
 7.1.5.2 When reference items are received applicable to the proficiency test
 
 7.1.5.3 When the results have been submitted to the proficiency test provide
 
 7.1.5.4 When the formal report is issued by the proficiency test provider
 
 7.1.6 Data generated as a result of quality assurance activities are recorded and
 
 ensures trends are detectable both within the quality assurance activity
 immediately performed, and when compared to the results of previous quality
 assurance activities. Where applicable to determine clear results, statistical
 techniques are included in plans for quality assurance activities and analysis of
 results. 
 
 7.2 Methods 
 
 7.2.1 Lab Management utilizes appropriate methods for quality assurance activities.
 The methods may vary from year to year. Allowable methods will include
 where appropriate, but not be limited to: 
 
 7.2.1.1. Participation in inter-laboratory comparison or proficiency-testing
 
 programs. 
 
 
 

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 (Proficiency Testing) 
 
 7.2.1.1.1 Third-party programs such as the National Association for
 Proficiency Testing (www.proficiency.org) or others may
 be used if appropriate testing exists. 
 
 7.2.1.2 Replicate tests using the same or different methods. 
 
 7.2.1.3 Retest within the same sample (may be a retained sample).
 
 7.2.1.4 Correlation of results for different characteristics of a sample.
 
 7.2.1.5 Review of reported results. 
 
 7.2.1.6 Intra-laboratory comparisons. 
 
 7.2.1.7 Testing of blind samples. 
 
 7.2.1.8 Participation in inter-laboratory comparisons other than proficiency
 testing. 
 
 7.2.1.9 Intermediate checks on measuring equipment. 
 
 7.2.1.10 Use of check or working standards with control charts, where
 applicable. 
 
 7.2.1.11 Functional check(s) of measuring and testing equipment.
 
 7.2.1.12 Use of alternative instrumentation that has been calibrated to provide
 traceable results. 
 
 7.2.1.13 Use of reference materials or quality control materials.
 
 7.2.2 Work instructions for completing the quality assurance activity may be
 developed and provided to participants if deemed necessary by Lab
 Management. Resulting work instructions will be controlled in accordance with
 SOP C-501 Document Control Procedure. 
 
 7.3 Results 
 
 7.3.1. During planning, Lab Management determines the format used to record the
 results including but not limited to data tables, charts, logs, and/or statistical
 means to provide thorough objective evidence of the results and to complete the
 comparisons and analysis. The data may be added on a specified worksheet in
 
 
 

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 (Proficiency Testing) 
 
 the Quality Assurance Activities Schedule and Results spreadsheet or
 maintained separately. 
 
 Fide Where the results indicate an acceptable result, the Quality Assurance Activities
 Schedule and Results spreadsheet is updated, and the activity is designated as
 
 “pass”, 
 
 7.3.3 Where the results are found to be outside the pre-defined criteria, the Quality
 Assurance Activities Schedule and Results spreadsheet is updated, and the
 activity is designated as “fail”. The impact of the situation will be assessed to
 determine if reports with inaccurate tests have been delivered to customers.
 
 Corrective action will be taken as appropriate to prevent incorrect results from
 being reported in accordance with the QS-108 Corrective and Preventative
 Action procedure. Training is provided in accordance with SOP A-113 Training
 Procedure. 
 
 7.3.3.1 As a part of closure on the corrective action and a verification of the
 
 actions taken to prevent recurrence of the root cause, Management will
 set a time frame (without undue delay) to repeat the test data
 validation. 
 
 7.3.4 All records associated with the activities and data analyses will be maintained in
 accordance with SOP C-502 Record Storage, Retention, and Destruction.
 
 8.0 Management Review 
 
 8.1 Results of Quality Assurance Activities are submitted for management review. The
 results may be submitted in their entirety, or a summary of the results and subsequent
 actions may be developed for submittal to top management. 
 
 9.0 Process Outputs 
 
 9.1 Process outputs include, but are not limited to: 
 
 9.1.1 Completed activities demonstrating valid test results. 
 
 9.1.2 Corrective actions taken when results are not acceptable. 
 
 10.0 Revision History 

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 10/06/21 | New procedure N/A J. Sassman | - | - |

 
 

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