Pace Clarification Response Pace Cont 1.pdf

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Signature Manifest

Document Number: ENV-SOP-CORQ-0018 Revision: 00

Title: Procedures for Corrective and Preventive Action (CAPA)

All dates and times are in Central Time Zone.

ENV-SOP-CORQ-0018

QM Approval

Name/Signature Title Date Meaning/Reason

Kirstin Daigle (007621) Director - Environmental Quali 02 Nov 2020, 09:33:37 AM Approved

Management Approval

Name/Signature Title Date Meaning/Reason

Michael Fuller (005537) SVP, COO - Environmental Scien 21 Oct 2020, 10:22:56 AM Approved

Kirstin Daigle (007621) Director - Environmental Quali 22 Oct 2020, 10:24:02 AM Approved

PROCESS STANDARD OPERATING PROCEDURE

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

1.0 PURPOSE

This standard operating procedure (SOP) describes the requirements and procedures used by the environmental sciences division (ENV) of Pace Analytical Services, LLC (PAS) for corrective and preventive action (CAPA).

2.0 SCOPE AND APPLICATION

The procedures in this SOP apply to all ENV locations and is the SOP adopted by corporate personnel and each ENV site location as the SOP for this process.

This SOP is used in conjunction with the following SOPs:

ENV-SOP-CORQ-0017 Quality Incidents

This SOP does not apply to for the following ENV locations:

Pace ENV locations operating as Aerobiology

3.0 SUMMARY

The corrective action and preventive action (CAPA) process is used to correct and prevent nonconforming work including but not limited to departures and deviations from policies, SOPs, issues that affect the quality of work product or the integrity and usability of test results and data, client complaints, audit deficiencies, proficiency testing (PT) failure or any other problem.

The corrective action process in this SOP is based on the ISO 7 stages of corrective action described as: problem identification, scope and risk assessment, correction, cause analysis, corrective actions, risk mitigation, preventive action and follow up to verify sustainability and effectiveness of actions taken.

The complexity of the process used for the problem is matched to the risk and scope of the problem.

Qualtrax, a compliance management software, is the software system used to track and document CAPA activities. Data from across the network is stored in the same database and all locations use the same CAPA workflows. Centralization and standardization provide transparency, consistency, and real-time access to data for tracking, monitoring and data analysis.

CAPA data is used by quality, technical, operation, and business managers to monitor on-going effectiveness of corrective actions, to identify trends requiring closer examination, opportunities for process improvement, and/or needs for additional action, such as targeted audits.

Information from data analyses are included in management reports including the monthly quality reports prepared by each Pace location and the monthly quality program reports prepared by corporate quality personnel.

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

4.0 DEFINITIONS

Acceptance Criteria: Specified limits placed on characteristics of an item, process, or service defined in requirement documents.

Correction: Action taken to eliminate a detected nonconformity. (ISO)

Corrective Action: Action taken to eliminate the cause of a nonconformity and prevent recurrence.

(ISO)

Data Integrity: The condition that exists when data are sound, correct, and complete, and accurately reflect activities and requirements.

Finding/Deficiencies: An assessment conclusion, referenced to a laboratory accreditation standard and supported by objective evidence, that identifies a deviation from a laboratory accreditation standard requirement.

ISO: International Standards Organization. ISO/IEC 17025 is the basis for the TNI Standard and Pace ENV quality programs.

Nonconformity: Non-fulfillment of a requirement (ISO)

Preventive Action: Action taken to eliminate the cause of a potential nonconformity or other potential undesirable situation. (ISO)

Qualtrax: A commercially available compliance management software system.

Risk: A situation involving the potential negative or positive exposure to Pace or Pace customers.

Standard: The document describing the elements of laboratory accreditation, developed and established within consensus principles of standard setting meeting the approval requirements of standard adoption organizations procedures and policies.

TNI: The NELAC Institute. The TNI Standards, in addition to ISO/IEC 17025:2017, are the Standards used as the basis for the Pace ENV quality program.

Workflow: A sequence of tasks and steps that move the user through the process.

5.0 PROCEDURE

5.1 Concept and Process Overview

The CAPA process is one of the most effective tools we can use to achieve our quality goals and reduce costly rework and inefficiencies.

Sometimes the actions we take are not always effective and the same problem occurs again and again. This is a common problem and happens when corrections are confused with corrective actions and corrective action with preventive action.

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

To implement a successful CAPA process, it’s important to understand these concepts, how to apply them, what is involved, and what to avoid.

5.1.1 Key Concepts: Correction, Corrective Action, and Preventive Action

To understand the difference between each of these concepts, it’s helpful to translate the ISO definitions as follows:

Correction is an action taken to contain the problem.

Corrective Action is action taken to address the cause of a problem and prevent the problem from occurring again.

Preventive Action is action taken to prevent a problem from ever occurring.

Preventive action prevents occurrence, corrective action prevents recurrence, and correction contains the problem.

5.1.2 Concept Application Example

A real-world example helps to further distinguish the differences between concepts.

Problem: The test result was incorrect due to a formula error in an Excel spreadsheet.

Correction(s): Include fixing the equation in the spreadsheet, recalculating the result, and issuing a revised test report to the customer. Each of these actions contain the problem but do not address the cause of the problem.

Corrective Action: Involves looking at the process used to create the spreadsheet and generate the test result to determine what caused the spreadsheet error and why the error was not found before the spreadsheet was put to use or after using the routine checks and balances in place. This review process is called cause analysis.

Processes reviewed during the cause analysis would include:

Spreadsheet Validation Document Control and Document Management Primary/Secondary Data Review Internal Audits

Corrective Action(s): could be multiple actions to address process flaws and gaps found during cause analysis such as:

Updating the spreadsheet validation SOP to include: two-person verification of the accuracy of output for each equation in the spreadsheet;

Password protecting cells that contain calculations;

changing the data review procedure to include at least one manual recalculation of a test result per batch for any results calculated by spreadsheet, TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

updating the internal audit schedule to include a monthly check of all spreadsheets used to verify the spreadsheet is password protected and no unverified changes were made since the last check;

more frequent auditing of test methods that use spreadsheets for calculations.

Each of these corrective actions could prevent recurrence of equation errors in spreadsheets in the future. The corrective actions taken depend on the direct cause(s) of the problem.

Preventive Action: Involves evaluating the risk associated with the use of spreadsheets to calculate final test results in all work areas. A decision to replace these spreadsheets with data reduction software before a problem occurs is preventive action. If the problem has already occurred; then the decision to replace the spreadsheet with other software is a corrective action.

5.1.3 Corrective Action Process – 7 Stage Process

Corrective action is an incremental process that includes 7 stages with multiple steps at each stage.

Stage 1: Identification & Containment

Define the Problem Determine the Scope of Problem Contain the Problem (Correction taking immediate action)

Stage 2: Evaluation

Determine the need for corrective action Determine the level of risk and action required based on the risk of the problem

Stage 3: Investigation

Identify work areas & processes related to the problem Identify resource needs such as manpower, expertise and assign responsibilities for each step of the process.

Stage 4: Cause Analysis (CA)

Use a CA method(s) to identify cause(s).

See Appendices A & B for Cause Analysis Tool Guides

Stage 5: Corrective Action Plan

Develop an action plan of tasks to correct the cause(s) identified Review and Approve the corrective action plan

Stage 6: Implement Plan

Execute the tasks

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

Record actions taken and compile objective evidence that proves the task was completed, employees were trained on any process changes, and the change was implemented.

Stage 7: Follow Up & Effectiveness Check

Verify tasks were completed as planned and objective evidence is complete.

Verify the tasks are appropriate to solve the cause(s) Ensure proper controls and responsibilities are in place to prevent recurrence Make sure the actions taken do not create adverse effects Assess risk of same problem occurring in other work areas; take preventive actions where needed to mitigate risk.

Verify the actions taken were effective and are sustained. (See Section 5.3.2.1).

5.1.3.1 Band Aid Solutions – What to Avoid!

Avoid “Band Aid Solutions” as corrective actions.

A band aid solution is a quick, superficial, or temporary solution to a problem that does not address or resolve the underlying cause of problem.

Band aid solutions address the symptom of the problem, not the cause of the problem.

A good example of a band aid solution to failure to follow a procedure is refresher training.

Refresher training is a superficial fix because it does not resolve the cause of the problem, even when the problem is lack of skills or knowledge, which is the reason training is performed.

If the cause of the problem is lack of skills or knowledge when training on the procedure was completed, then re-training is a correction because it only contains the problem.

Cause analysis would need to address the reason(s) why training did not produce desired results and corrective actions would include improving the training process.

If training was never performed, then refresher training is a misnomer. The correction is to perform initial training and the corrective actions would need to address the reason(s) training was not performed.

If lack of knowledge or skill of the procedure was not the reason for the problem, then retraining might temporarily prevent the problem from happening again, however, other corrective actions, such as performance management, process monitoring, process improvement will be more effective to prevent recurrence.

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

Temporary solutions, such as refresher training, need to be supplemented with corrective actions that resolve the underlying cause of the problem for the corrective action to be effective.

5.1.4 CAPA = Risk Based Thinking

CAPA is progressive, which means the complexity of the process used to address the problem is matched to the risk and scope of the problem.

Managers must use judgment to determine how to handle different situations.

Overuse of corrective action can be as ineffective as underuse. Not every situation requires corrective action; sometimes a correction is adequate. Managers need to use judgment and data to know when to escalate the process.

The following bullets provide some examples of the application of risk-based judgment based on the nature of the problem:

For a first-time problem, with low probability of recurrence and no negative impact to the customer(s) or to Pace, a correction may be all that is needed. If the problem occurs again, then the need for cause analysis and corrective action should be evaluated.

Test method SOPs call day to day actions taken to correct instrument or preparation quality control (QC) acceptance criteria failures corrective action. However, these actions are truly just corrections made to resolve that day’s QC failure. Only the steps listed under Stage 1 of the corrective action process are performed at this juncture.

However, if the same QC failure becomes persistent, identified through monitoring, observation, control charting, or audits, then corrective action is escalated to include all stages of the process.

The 7- stage corrective action process is always required for customer complaints about the quality of work product.

5.1.5 Preventive Action

Although the acronym CAPA implies preventive action (PA) is part of the process, most ISO guides for corrective action do not include steps for preventive action (PA).

ISO defines PA as actions taken to prevent a problem before it ever occurs. If the action is taken in response to a known problem, then the action is a corrective action.

Opportunities for PA are typically identified during systems and process development, cost/benefit analysis (CBA), and risk management evaluations, which are generally considered front-end processes.

However, the focus of PA is to address a weakness in a system that could cause a nonconforming product or service and improve efficiency. Therefore, PA can be performed anytime utilizing information learned from the corrective action process to meet the PA objective.

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

This SOP includes a PA step to utilize information obtained during the process and is used real-time for risk mitigation.

5.1.5.1 Risk Assessment

Quality personnel use a risk assessment matrix to determine when preventive actions are needed based on the probability that the same problem will occur in other work areas and the impact of the problem should the problem occur.

The matrix is a tool that involves weighing the probabilities of occurrence of the problem against the impact of the problem if it occurs. The outcome of the grid helps classify risk from most severe to less critical to enhance decision making.

Use of the matrix simplifies and standardizes the risk assessment process.

Risk Assessment Matrix

P ro b ab ili ty

Impact

Insignificant 0.05

Marginal 0.01

Moderate 0.2

Critical 0.4

Catastrophic 0.8

Very Likely (90%)

0.05 0.09 0.18 0.36 0.72

Likely (70%)

0.04 0.07 0.14 0.28 0.56

Possible (50%)

0.03 0.05 0.10 0.20 0.4

Unlikely (30%)

0.02 0.03 0.06 0.12 0.24

Rare 10%

0.01 0.01 0.02 0.04 0.04

To use the matrix:

1. Review the problem and the causes of the problem arrived at from cause analysis.

2. Select probability that best represents the likelihood that the problem will occur again in any work area

3. Select the impact category that best represents risk to Pace and/or to our customer(s) if the problem were to occur.

4. Use the color code system to determine the risk level if action is required.

Green No Risk No Preventive Action Needed Yellow Low Risk Preventive Action Recommended Orange Moderate Risk Preventive Action Required: Med Priority

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

Pink High Risk Preventive Action Required: High Priority Note: Although this SOP describes the use of this tool to assess for preventive action, the risk assessment matrix can be used at any point in the process to determine the how to prioritize actions.

5.1.6 Standardized Nomenclature

To ensure acronyms and terms are used consistently across the network:

The acronym CAPA refers to any activity related to correction, corrective action, and/or preventive action.

Corrective action, except where noted otherwise in this SOP, refers to the 7-stage process.

5.2 Qualtrax CAPA Workflows

CAPA activities are carried out using automated workflows in Qualtrax.

A workflow is a series of steps that are completed sequentially to complete a process, such as

CAPA.

Each Qualtrax CAPA workflow is labeled “ENV-CAPA” to distinguish workflows used by ENV from other business units or other purposes.

The workflow maps each step of the process and passes the step automatically to the next responsible party until all steps in the process are completed. Review and approvals are built into the workflow to ensure the investigation is thorough, documented, and actions taken are appropriate to be effective. The Qualtrax software eliminates paper and provides quick retrieval of CAPA information for management reports and trend analysis.

For more information about Qualtrax workflows refer to the Qualtrax User Guide: Workflow Basics.

To access this guide, log-into Qualtrax from the Pace portal and select “Documents” from the Qualtrax User Menu or open the Favorites bookmark from the User Menu. Then select the document with this title to open. See any member of your local quality team for assistance if needed.

For questions about any of the Qualtrax ENV-CAPA workflows, send an email to Pace email address: Qualtrax_Administration or see your local quality manager (QM).

5.2.1 Qualtrax CAPA Workflow Creation & Maintenance

The Qualtrax CAPA workflows are created and maintained by corporate quality personnel in order to establish and maintain a standardized CAPA process for the network.

5.2.2 Qualtrax CAPA Launcher Workflows

Launcher workflows are created for quality personnel use only. In a launcher workflow, common information about a specific event, such as an audit or proficiency testing (PT)

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

failure is entered one time and separate CAPA workflow instances are created (launched) for each problem that requires corrective action.

The type of workflow instance created is set in the workflow definition by corporate quality personnel. For example, the workflow called ENV-CAPA-PT Investigation Launcher creates separate “ENV-CAPA PT Investigation” workflow instances for each PT failure entered in the sub form field that triggers the launch.

5.2.3 Qualtrax CAPA Process Workflows & User Guides

Process workflows are created for use by all personnel. The workflows guide personnel through each step of the corrective action process. Different workflows are created for different situations depending on the nature of the problem and the level of CAPA required.

The following sections briefly describe the CAPA workflows in place at the time of publication of this version of this SOP. Workflows may be added or removed at the discretion of corporate quality personnel.

For current instructions about when to use and how to use each workflow, refer to the workflow’s Qualtrax User Guide. Access the User Guide from “Document” in the Qualtrax User Menu.

5.2.3.1 Qualtrax ENV-CAPA-PT Investigation Workflow

Use the PT Investigation workflow for the investigation and corrective action of results scored not acceptable in any PT study.

5.2.3.2 Qualtrax ENV-CAPA-Audit Workflow

Use the Audit workflow for the investigation and corrective action for internal and external audit deficiencies.

5.2.3.3 Qualtrax ENV-CAPA-7 Stage

Use this workflow for any situation (except as noted) that requires corrective action including but not limited to:

Customer Complaints

Customer Request for Corrective Action

Internal Observation

Policy, SOP, Quality System Deviations

Systematic quality control (QC) failure

Systematic Process Error that does not cause test results to be incorrect. When systemic error results in changed test results, the quality incident workflow is used. See Section 5.2.3.4, TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

Other – other issues showing possible systematic problems or areas of improvement.

Do not use the CAPA-General workflow for data inquiries or recheck requests or for quality incident investigations. See next section for these procedures.

5.2.3.4 Quality Incident Workflows

The quality incident workflows are created specifically for management to carry out the CAPA process for quality incidents based on the procedures of SOP ENV-SOP-CORQ-0017 Quality Incidents. Refer to this SOP for more information.

5.2.3.4.1 Qualtrax ENV-CAPA Data Inquiry and Recheck Workflow

Use the ENV-Data Inquiry and Recheck workflow to investigate inquiries from external parties related to integrity and usability of final test results or data.

These inquiries are often called “rechecks” because the client has asked the laboratory to recheck the result reported because it does not match historical data or the deliverable has some other anomaly, such as missing data for a requested test method.

This workflow includes the option for the QM to launch a Quality Incident workflow (See 5.2.3.3.2) from the workflow instance when the investigation of the inquiry confirms a problem, the cause of the problem is lab error, and the error has the potential to affect test results and data reported to multiple customers.

The launch feature is an example of how the workflows are designed to escalate the CAPA process based on the circumstances and manager judgment.

5.2.3.4.2 Qualtrax-ENV-CAPA Quality Incident Workflow

Use the Quality Incident workflow to investigate Category 3 and Category 4 quality incidents in accordance with SOP ENV-SOP- CORQ-0017 Quality Incidents.

5.3 Data Analysis & Management Reports

5.3.1 Data Analysis

The centralized Qualtrax database provides for on-demand data queries (reports) of information in any of the CAPA workflows. This data is queried on a routine basis and reviewed by local and corporate management to identify trends, additional needs for corrective action, and opportunities for improvement.

Refer to Qualtrax User Guide-CAPA Workflow Reports for instructions on how to use the data query/report features of Qualtrax.

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

5.3.1.1 Monthly

Local quality personnel compile the number of corrective actions by time-frame open and report this data in the Monthly Quality Report (See Section 5.3.2).

Every 2-4 weeks, but no less frequent than each calendar month, CAPA workflow data must be downloaded to Excel and reviewed by local quality personnel for each location they are responsible for to look for trends in the data and to address any corrective actions that are past due. Large scale operations may need to conduct this review more frequently.

Corrective actions that are past due should be discussed with the CAPA Leader, the QM, GM, and the individual responsible for the past due step to determine the reason for the bottleneck and to establish a timeframe for activity.

Trends to look for include but are not limited to pattern of repetition with a type of problem, a process, a test method, a work area, an employee, software product, or customer. When trends are found, the QM must make the decision to initiate CAPA or continue to monitor the situation.

Quality personnel are expected to use the data analysis features of Excel that works best for them to identify trends. This may include pivot tables, charts, graphs. Local quality staff should work with their QM and their Quality Program Manager (QPM) to come up with a process that meets the needs of the operation.

Records of the monthly CAPA review must be retained by the local quality department.

5.3.1.2 Quarterly

On a quarterly basis macro data from CAPA workflows is reviewed and analyzed by corporate quality personnel. Trends observed are shared with the senior leadership team, and regional and local management with any recommendations for follow-up or other actions.

5.3.1.3 Annually

CAPA data over the last 13 months is reviewed by each location during the location’s annual management review.

See SOP ENV-SOP-CORQ-0005, Management Review for these procedures.

5.3.2 Management Reports & Effectiveness Check

The number of open corrective actions is reported by each location in the Monthly Quality Report.

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

The QM prepares this report on a monthly basis following the instructions in the report template. The report is submitted to the Corporate Compliance Analyst, who consolidates the information from each individual location into a summary report. The summary report is distributed to senior leadership, and regional and local management.

The metric report is designed to identify risk related to corrective actions that are have not been completed within 60-90 days. Although the time frame to plan and execute corrective action is situation specified, it is generally expected that the corrective action is closed within 30 days with effectiveness check(s) to follow at time frames appropriate to the severity of the problem.

5.3.2.1 Effectiveness Checks

Effectiveness checks are performed by quality personnel to verify that the corrective action(s) taken has or has not eliminated the problem. At least 3 checks are required and the CAPA workflow is set up to meet this requirement.

The first check is performed immediately after corrective and preventive actions (when required) are completed. This check involves confirmation that the actions were put in place.

The other two checks are performed to verify the solution worked and are sustained over time. These checks are typically spread out over several months after the initial actions are taken. The timeframe between each effectiveness review check is discretionary but should be at least 30 days apart.

The Qualtrax CAPA workflows are designed to close the CAPA workflow instance when the corrective action is complete and to re-open the instance at for the effectiveness check at a future date(s) selected by the QM.

When choosing a date to perform the next check, the QM must allow enough time for the actions taken to take effect while balancing the risk that the problem will recur if the actions were not effective to solve the issue.

5.3.2.1.1 Methods for Effectiveness Checks

Effectiveness checks must be performed by using any combination of the following options:

Verification Checks: A one-time or multiple checks to confirm the action(s) taken are still in place. For example, if the corrective action was to put in place a process for weekly clean-out of expired standards from the work area, quality personnel may periodically check the storage area for expired standards.

Trend Analysis: Involves review of data over the time from when the action was taken to determine if the problem has recurred after action was taken or less frequently since then.

Since it takes time for corrective actions to make an effect, TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

quality personnel should look for a decreasing trend in frequency to the point where there should be no/infrequent recurrence.

Special Audits: Audits are performed by quality personnel to verify the prescribed corrective action is being followed in the work area. These audits are not pre-scheduled with the department because the purpose is to observe the daily activities in the work area as they normally occur.

5.3.2.1.2 Effectiveness Check Results

The results of the checks are recorded in the workflow instance.

When the check identifies the action taken was not effective, the corrective action process must be re-opened and supplemental actions taken.

5.3.2.1.3 Supplemental Corrective Action

When the original actions taken were not adequate to resolve the issue, the CAPA Leader and the department leader must review the situation to determine why the action(s) taken did not work then start the process over.

The most common reasons corrective actions did not work are:

The corrective action was a correction– it contained the isolated problem but did not fix the underlying cause.

The corrective action did not match up with the cause – it was a band-aid solution.

The root cause(s) were not properly determined.

There was lack of follow-through and supervision to make the change or sustain the change.

The supplemental corrective action process must address the original problem and the reason the original corrective action was not effective.

5.3.2.1.4 Management Expectations

CAPA is led by management.

For the process to be successful, the management team must critically assess the situation, objectively identify the cause of the problem, fix the problem, monitor the fix, and commit to follow-up when things aren’t working.

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

6.0 RESPONSIBILITIES

Pace ENV employees that perform any part this procedure in their work activities must have a signed Read and Acknowledgement Statement in their training file for this version of the SOP. The employee is responsible for following the procedures in this SOP and handling temporary departures from this SOP in accordance with Pace’s policy for temporary departure.

Pace supervisors/managers are responsible for training employees on the procedures in this SOP and monitoring the implementation of this SOP in their work area.

7.0 ATTACHMENTS

Appendix A: Cause Analysis Tool Guide: 5 Why’s Appendix B: Cause Analysis Tool Guide: 4M

8.0 REFERENCES

Laboratory Quality Manual, current version.

ISO/IEC 17025:2017

ENV-SOP-CORQ-0017 Quality Incidents, current version.

9.0 REVISION HISTORY

This Version:

Section Description of Change NA This is the first version of this SOP.

This document supersedes the following document(s):

Document Number Title Version

ENV-SOT-CORQ-0012 Corrective Actions 00

Various Any lab SOP based on the SOT Various

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

Why did this happen? An expired standard was used for calibration.

Why was an expired standard used? A new standard was not available.

Why was a new standard not available? The replacement order had not been placed.

Why had the order not been place? There is no procedure in the work area to manage inventory and ordering of standards.

Why is there no procedure? Manager oversight.

Appendix A: Cause Analysis Method: 5 Why

The 5 Why method includes asking 5 questions where the prefix of each question starts with “why” and the answer to the question forms the basis for the next question.

How it Works:

1. Write down the problem and describe it completely. This step helps the team focus on the problem.

2. Ask Why the problem happens and write down the answer.

3. Ask Why using the answer from the prior question, write the answer down.

4. Loop back to Step 3 until the team agrees the cause of the problem is identified.

Example: The result reported for cyanide in the last PT study for drinking water was scored unacceptable.

Root Cause(s): No Procedure & Manager Oversight

TITLE: Procedure for Corrective and Preventive Action (CAPA)

ISSUER: Corporate Quality – Environmental Sciences

COPYRIGHT © 2020 Pace Analytical Services, LLC.

Any printed copy of this SOP and all copies of this SOP outside of Pace are uncontrolled copies.

Uncontrolled copies are not tracked or replaced when new versions are released, or the SOP is made obsolete.

Users of the SOP should verify the copy in possession is the current version of the SOP before use.

• Were protocols clear and understandable?

• Were working conditions optimal for test?

• Did equipment and supplies meet specfiicatons?

• Did reagents and standards meet specification?

• Did staff follow SOP(s)?

• Was analyst/data reviewer aware of problem?

• Is training current?

• Is level of expertise for task appropriate?

• Did my instruments work correctly?

• Were they in calibration?

• Was maintenance up to date?

Machine Manpower

MethodMaterials

Appendix B: Cause Analysis Method: 4Ms

This method correlates the relationship between the problem and its potential causes by first classifying the source of the error(s) under one of 4 categories: Machine, Manpower, Method and Materials.

How to Use this Method:

1) For each category brainstorm different questions that may have caused the problem. Some leading questions are provided in the text boxes for each quadrant to help start the process.

2) Once all the possible causes are identified, address each cause with a correction and a corrective action.

5.1.6 Standardized Nomenclature