Change Control for CAPA Implementation
A practical guide to converting corrective and preventive actions into controlled, risk-assessed changes with the right approvals, regulatory review, validation, implementation evidence, and effectiveness checks.
How should a CAPA action be implemented through change control?
When a CAPA action changes an approved process, procedure, method, material, equipment, software, facility, or validated state, link it to the site’s change-control process. Define scope, risk, regulatory impact, prerequisites, approvals, training, and acceptance criteria before implementation. Verify the change was installed as approved, then assess whether it corrected the cause without creating new quality risks.
Connect the investigation to the implementation
What is change control for CAPA implementation?
A CAPA investigation may identify an action that changes a controlled part of the pharmaceutical quality system. Change control provides the documented route to assess that proposal before execution, involve the right functions, set prerequisites, and confirm the result after implementation.
Defines the quality problem
Describes the event or trend, affected scope, risk, investigation evidence, supported cause, action rationale, owner, due date, and criteria for checking effectiveness. The CAPA record remains the improvement case.
Controls the proposed solution
Defines the before-and-after state, impact assessment, approvals, regulatory assessment, validation or qualification, documents and training, implementation plan, acceptance criteria, and post-change review.
Connects why to how
The CAPA record should identify the linked change-control record and track its status. The change record should reference the CAPA and its cause, risk, intended outcome, and effectiveness measures.
Keep ownership clear
CAPA vs. change control: how the records work together
| Question | CAPA record answers | Change-control record answers |
|---|---|---|
| Why is action needed? | What happened, what is the cause, what is the risk, and why is the selected action suitable? | How does the proposed change address the approved CAPA action? |
| What is changing? | Describes the intended improvement and affected scope at an action level. | Defines systems, processes, documents, equipment, sites, products, procedures, specifications, and before/after configuration. |
| Who evaluates and approves? | CAPA owner and Quality approve the cause, action plan, risk, and effectiveness approach under procedure. | Cross-functional change reviewers assess technical feasibility, impact, controls, filing needs, and prerequisites. |
| What proves implementation? | Evidence that the corrective action was completed as assigned. | Approved documents, training, qualification, validation, release, configuration, and implementation records. |
| What proves success? | Effectiveness evidence that the cause was controlled and recurrence risk reduced. | Post-implementation review that the change met its criteria and did not cause unintended product-quality effects. |
| When does it close? | After action completion, effectiveness review, and required Quality approval. | After approved implementation, review, unresolved tasks, and change-closure approvals are complete. |
One CAPA can link to several change records, and one cross-functional change may support more than one CAPA when the rationale and traceability are clear. Keep ownership, milestones, and closure status visible in both systems so neither record is closed on an unverified assumption.
Risk-based pharmaceutical quality system
Regulatory and GMP principles behind CAPA change control
ICH Q10 connects CAPA and change management: CAPA investigations can drive change, proposed changes should be evaluated using quality risk management, assessed against the marketing authorization and current product/process knowledge, reviewed by appropriate experts, and checked after implementation. ICH Q12 adds principles for managing post-approval CMC changes; reporting requirements depend on the applicable region and product authorization.
Assess prospectively and review afterward
Set the evaluation effort in proportion to risk, involve relevant technical and quality expertise, determine regulatory filing implications, establish prospective criteria, and confirm the change achieved its aim without harming product quality.
Connect internal control with regulatory management
Consider the complete scope and implications of a change across the process and control strategy, determine data needed, involve Quality and Regulatory Affairs, file where required, and assess post-implementation performance.
Start with the controlled state
Which CAPA actions should enter change control?
Route an action through formal change control when it modifies, replaces, or retires a controlled GMP condition and the site procedure requires change review. Use the SOP’s scope rules and record a reasoned decision for borderline cases. The name of the CAPA action alone does not determine the route.
| CAPA action area | Potential controlled change | Assessment to document |
|---|---|---|
| Process and manufacturing | Change to process steps, operating ranges, in-process controls, hold times, scale, sequence, or control strategy. | Affected products, batches, process knowledge, process performance, validation state, and required comparability or verification work. |
| Equipment, facility, and utilities | Equipment replacement or modification, layout changes, utility changes, or new operating limits. | Intended use, qualification, calibration, maintenance, cleaning, environmental controls, and interfaces with other systems. |
| Materials and suppliers | New or changed raw material, component, supplier, specification, source, or outsourced activity. | Material criticality, supplier qualification, incoming controls, product impact, contracts, and market authorization commitments. |
| Laboratory controls | Analytical method, instrument, sampling plan, specification, reference standard, or laboratory software changes. | Method performance, data comparability, validation or verification, instrument qualification, sample impact, and result reporting. |
| Computerized systems and data | System configuration, interfaces, access roles, calculations, audit trail settings, or records migration. | Intended use, validation, security, audit trail, backup, data migration, access, and record retention. Protect ALCOA+ data integrity. |
| Quality documents and training | New, revised, or retired SOPs, forms, specifications, batch records, work instructions, or training materials. | Document approval and effective date, linked records, affected roles, read-and-understand or qualification needs, and obsolete-copy control. |
| Packaging and labeling | Packaging equipment, line settings, artwork, component, inspection, reconciliation, or label-control changes. | Product identification, market-specific artwork, line clearance, mix-up controls, packaging validation, and disposition of printed materials. |
Build a complete assessment before approval
CAPA change-control impact assessment checklist
Describe the current state, proposed state, reason for change, and affected boundaries before selecting impact reviewers. Assess both the change itself and the risk of delaying it. A practical assessment prompts reviewers to consider:
| Impact area | Questions for the review team | Possible evidence or control |
|---|---|---|
| Product and patient risk | Could identity, strength, quality, purity, safety, efficacy, contamination control, or supply be affected? | Product impact rationale, affected lots or markets, product-quality risk assessment, and disposition decision. |
| Process and control strategy | Does the action affect a critical parameter, control limit, process sequence, sampling, or approved operating range? | Process map, supporting trend or development data, monitoring plan, and justified acceptance criteria. |
| Regulatory and market status | Does the change touch a registered commitment, marketing authorization, filed control strategy, or market-specific reporting pathway? | Regulatory Affairs assessment by product and jurisdiction, with the applicable filing or notification path and timing. |
| Validation and qualification | Must equipment, utilities, process, cleaning, method, software, transport, or packaging be qualified, validated, or reverified? | Approved protocol, rationale for scope, acceptance criteria, executed results, deviations, and final report. |
| Documents and people | Which controlled documents, forms, master records, training curricula, or role qualifications must change? | Document list, approved effective dates, training completion records, and prevention of premature use. |
| Data and systems | Could records, calculations, access, audit trails, interfaces, retention, or data migration be affected? | System impact assessment, testing, access review, backup or migration controls, and data reconciliation as applicable. |
| Supply chain and outsourcing | Are suppliers, contractors, contract laboratories, logistics, or regulatory partners affected? | Supplier assessment, quality-agreement updates, communication records, incoming controls, and outsourced activity oversight. |
| Timing and transition | How will open batches, work in progress, inventory, old and new versions, or a delayed implementation be controlled? | Cutover plan, segregation or depletion rationale, interim controls, owner, monitoring period, and contingency plan. |
Use the site’s approved quality risk management method. A risk score can help rank review effort, but it should not replace evidence, expert judgement, regulatory review, or required approval.
Right expertise, clear accountability
Roles and responsibilities for CAPA-driven change
Owns the quality rationale
Maintains the investigation, supported cause, action rationale, assigned owners, risk rationale, due dates, and effectiveness criteria. The owner links the CAPA to related change records and reports dependencies or delay.
Coordinates the implementation plan
Defines the proposed state, impact boundaries, work packages, prerequisites, reviewers, acceptance criteria, implementation sequence, evidence, and post-change review. A single accountable owner keeps the plan coherent.
Provides independent quality oversight
Reviews risk and GMP impact, confirms required approvals and controls, evaluates deviations, and authorizes progression or closure under the site procedure. Quality oversight does not replace technical ownership.
Functional reviewers
Manufacturing, Engineering, QC, Validation, IT, Regulatory Affairs, Supply Chain, and the Qualified Person or other required roles review the areas they own. Reviewers should be selected from the impact assessment, not copied mechanically from a fixed list.
Management oversight
Escalation and governance forums review high-risk, cross-site, overdue, or resource-constrained changes as defined by procedure. Management helps resolve dependencies while the authorized functions retain technical and quality decisions.
A controlled path from cause to evidence
Step-by-step workflow for change control in CAPA implementation
Use this workflow with the company CAPA and change-control SOPs. The required forms, approval roles, and records vary by organization, product, and jurisdiction.
Confirm CAPA cause and action
Check that the investigation supports the cause and that the proposed action addresses it. Define the intended quality outcome and link the investigation evidence.
Output: approved CAPA rationaleDecide whether formal change control is required
Compare the action with the site procedure’s scope and triggers. If the route is uncertain, seek Quality review and document why the chosen pathway is appropriate.
Output: route decision and rationaleDefine scope and before/after state
Identify affected products, sites, process steps, documents, equipment, systems, materials, suppliers, markets, and batches. State what will and will not change.
Output: bounded change descriptionAssess risk and impact of delay
Evaluate risk from implementing the proposal and risk from leaving the current state in place. Consider severity, likelihood, detectability, uncertainty, and existing interim controls using the approved method.
Output: documented risk assessmentEvaluate regulatory and market requirements
Have Regulatory Affairs determine whether authorization, filing, notification, or other market-specific action is needed and when implementation may proceed.
Output: regulatory impact decisionSet prerequisites, data, and acceptance criteria
Define necessary studies, qualification, validation, documents, training, testing, cutover controls, objective success criteria, and the evidence that must be available before each milestone.
Output: approved implementation planObtain cross-functional approval before implementation
Route the complete proposal to the required technical, Quality, and regulatory reviewers. Approval confirms the plan and prerequisites; it does not authorize any filing-dependent implementation before its permitted timing.
Output: prospective authorizationComplete documents, training, and qualification
Revise and approve controlled documents, complete required training, qualification, validation, or system testing, and ensure the new state is not used ahead of its approved effective point.
Output: prerequisite evidenceImplement under approved controls
Execute the authorized plan, record actual dates and configuration, preserve traceable evidence, and open linked deviations if results depart from approved instructions or acceptance criteria.
Output: execution recordVerify implementation against plan
Confirm each deliverable was completed as approved, including document status, training, installation or configuration, required testing, affected lots, and any open tasks or deviations.
Output: implementation verificationCheck CAPA effectiveness and unintended effects
Evaluate prospective CAPA criteria using a justified observation period and data set. Confirm recurrence is controlled and assess for adverse or unintended product, process, or system effects.
Output: evidence-based effectiveness reviewClose linked records and trend learning
Complete change and CAPA closure checks, reconcile linked actions and deviations, record approvals, update applicable risk or knowledge records, and share recurring lessons through governance.
Output: traceable closure and learningCoordinate internal and external obligations
Regulatory change assessment before implementation
Regulatory Affairs should determine whether the proposed CAPA change affects a marketing authorization, registered control strategy, product dossier, or other commitment in each affected market. The required reporting category and timing differ by jurisdiction and product. Record the rationale, the source reviewed, any submission or notification, and the condition that must be met before implementation.
Assess the registered state
Compare the proposal with approved particulars and commitments, including manufacturing site, process description, control strategy, specifications, analytical methods, packaging, shelf life, and relevant supporting data. Ask whether the proposed state falls within an established post-approval management protocol or other agreed pathway.
Translate the decision into a gate
State whether an internal change can proceed immediately, only after a submission is made, only after approval, after an agreed notification period, or once another requirement is met. The responsible regulatory reviewer should define and document the applicable route.
Control the transition into the new state
Implementation controls: validation, documents, systems, and suppliers
Qualification and validation
Define the work needed from the intended use, change scope, product and process knowledge, and risk assessment. An approved protocol should state prerequisites, sampling or testing, acceptance criteria, handling of exceptions, and required report approval. Document why an existing validation state remains applicable when no new work is needed.
Document control and training
List procedures, batch records, forms, specifications, and work instructions that need revision. Sequence approvals and effective dates with training so staff can use only the current authorized instructions. Preserve obsolete controlled copies and link completed training evidence to the change.
Configuration and data integrity
Describe configuration, interface, access, audit-trail, calculation, migration, and retention impacts. Use risk-based testing and access controls appropriate to intended use. Preserve traceability, review exceptions, and reconcile migrated records where applicable.
External parties and supply transition
Assess supplier qualification, quality agreements, contractor instructions, material disposition, inventory, and market-specific supply constraints. Define communication ownership and confirm external parties use approved versions before the new arrangement takes effect.
Act quickly while keeping decisions traceable
Emergency changes, interim controls, and overdue CAPA actions
An urgent quality risk may call for immediate containment or a rapid controlled change. Follow the site’s documented emergency pathway, identify who can authorize it, capture the risk assessment and rationale, define the temporary state, and complete required review and records within the procedure’s stated time. Do not treat urgent need as permission to skip product-impact assessment or applicable regulatory obligations.
Use interim controls with an owner
Specify what is controlled while a permanent action is pending, who checks it, how often it is reviewed, how affected output is dispositioned, and what condition triggers escalation. Temporary measures need an expiry or review point and a clear link to the permanent CAPA action.
Reassess when timing changes
If an approved date becomes unrealistic, assess whether the current risk, product exposure, supply impact, interim controls, or regulatory plan has changed. Record the reason, revised due date, resource plan, approvals, and escalation. A due-date extension alone is not risk control.
Escalate recurring, critical, or high-impact delays through the designated Quality and management process. Follow Deviation Management and CAPA: When to Escalate when the event, action, or delay meets escalation criteria in the relevant SOP.
Apply the model to common situations
Examples of CAPA actions that use change control
| CAPA scenario | Change-control focus | Implementation evidence | Effectiveness evidence |
|---|---|---|---|
| Recurring temperature excursion linked to inadequate alarm response | Assess alarm settings, monitoring coverage, roles, work instructions, qualification, data records, and market or product impact. Define escalation thresholds and any interim controls. | Approved configuration, test results, revised procedure, staff training, alarm challenge or qualification, and disposition of affected material. | Trend alarms and response records over a justified period; verify timely response and check for further excursions or missed events. |
| Repeated analytical transcription errors | Determine whether the cause involves method design, system workflow, access, audit trail, training, or independent review. Evaluate software validation, data integrity, record retention, and historical result scope. | Approved workflow or configuration, risk-based testing, permissions review, updated procedures, training, and reconciliation of affected records if needed. | Sample data records for transcription errors, confirm audit-trail review, and assess recurrence and unintended delays or rework. |
| Mix-up risk during line clearance | Evaluate process sequence, line layout, status labels, packaging controls, visual aids, batch documentation, and any artwork or equipment impact. | Approved procedure and record revisions, qualification or simulation as applicable, training, line-readiness checks, and controlled removal of superseded materials. | Review a defined sample of subsequent line clearances, exceptions, reconciliation results, and product-quality events. |
These are illustrative examples. The actual change pathway, required testing, observation window, and acceptance criteria should come from the site risk assessment, approved procedures, product knowledge, and applicable regulatory requirements.
Prevent closure gaps before they occur
Common weaknesses in CAPA change implementation
Closing the CAPA when a task is merely approved
Approval is not evidence of completed implementation or effectiveness. Track linked change milestones and retain approved execution records before closure.
Writing a broad impact statement
Statements such as “no impact” are not self-supporting. Name the affected boundaries, products, markets, systems, and evidence reviewed; explain the conclusion.
Setting success criteria after results are known
Define the measure, data source, sample or observation period, owner, and pass/fail rule before implementation. This reduces hindsight and supports an objective effectiveness review.
Confusing implementation review with CAPA effectiveness
Document both: whether the plan was executed correctly, and whether the action controlled the cause and prevented recurrence over an appropriate period.
Ignoring filing or transition dependencies
Internal approval may not be the final authorization gate. Check market obligations, old and new inventory, open work, and the permitted implementation date.
Failing to manage linked records
Keep CAPA, change, deviation, validation, training, and document references connected. Reconcile open tasks and deviations before each record’s closure decision.
Match review effort to uncertainty and impact
Risk-based priority decisions for a CAPA change
Use a structured risk assessment to compare the current condition, proposed change, implementation hazards, and risk of waiting. Consider severity to the patient and product, likelihood, detectability, scope, uncertainty, and strength of interim controls. Include failure modes introduced by the change as well as the original CAPA problem.
What is the risk if nothing changes?
Consider recurrence, affected lots or systems, patient or product consequences, exposure, trends, and whether existing controls reliably detect the issue.
What new failure modes could arise?
Evaluate installation, process variability, human factors, software configuration, supplier performance, data integrity, transition, and unintended consequences.
What risk accumulates while waiting?
Review exposure duration, batch cadence, inventory, market impact, interim controls, resource dependencies, and whether the plan needs reprioritization.
A useful record can be reviewed and executed
CAPA change-control record template
A clear record lets reviewers understand the problem, proposed future state, authorization, execution, and evidence without reconstructing the decision from email. Adapt these fields to the company’s approved forms and electronic system.
| Record field | What to capture |
|---|---|
| Record identity and linkage | CAPA ID, change ID, related deviations, product/site/system identifiers, owner, Quality contact, and linked records. |
| Problem and proposed state | Supported cause, action rationale, current state, proposed state, boundaries, exclusions, and intended quality outcome. |
| Risk and impact | Product/process/system impacts, risk method and rationale, delay risk, affected markets, interim measures, assumptions, and unresolved questions. |
| Regulatory review | Reviewer, affected jurisdictions, applicable authorization or commitment, filing/notification route, evidence, and implementation gate or condition. |
| Implementation plan | Tasks, owners, due dates, prerequisites, dependencies, validation or qualification, document/training changes, supplier communication, cutover, and contingency. |
| Approval and execution | Required reviews and decisions, approval dates, approved plan version, actual execution dates, configuration or version, deviations, and objective evidence. |
| Verification and effectiveness | Implementation checklist, acceptance criteria, effectiveness measure, data source, sample or observation window, owner, outcome, and adverse-effect review. |
| Closure and learning | Open items, final approvals, CAPA/change closure rationale, related risk or knowledge updates, and follow-up actions or trend signals. |
Measure flow, quality, and sustained results
Change-control and CAPA implementation metrics
Use measures to reveal bottlenecks and quality signals, not to reward premature closure. Define each metric consistently, segment by change risk and function, and investigate adverse trends before setting improvement actions.
| Metric | Example definition | What it can reveal |
|---|---|---|
| CAPA actions awaiting linked change | Open CAPA actions with a change-control dependency, grouped by stage and risk. | Whether dependency is visible and whether approvals or resources are delaying implementation. |
| Change approval cycle time | Elapsed time from complete submission to authorized decision, reported by risk tier or change type. | Review bottlenecks, incomplete submissions, or unclear reviewer ownership. |
| Implementation on-time rate | Approved changes implemented by the current approved date divided by changes due in the period, with extensions separately visible. | Planning accuracy, resource constraints, and risk from overdue work. |
| Post-implementation deviation rate | Changes associated with an implementation-related deviation or exception during a defined follow-up period. | Readiness, plan quality, execution discipline, or inadequate transition controls. |
| CAPA effectiveness failure rate | Effectiveness checks that fail or require extended investigation divided by checks completed in the period. | Whether action design, root cause, implementation, or measurement plans are robust. |
| Repeat issue rate | Relevant recurrence events linked to a previously closed CAPA/change during a justified look-back period. | Longer-term control sustainability and recurrence across products, sites, or systems. |
| Open change actions by age and risk | Open implementation tasks grouped by overdue duration, risk, owner, and dependency. | Where escalation, interim controls, or management support may be needed. |
Set denominators, exclusions, time windows, and data sources in a metric definition sheet. Display both count and rate when volumes change, and avoid a single organization-wide target that makes a low-risk document update appear equivalent to a product-critical change.
A quick discussion aid
CAPA-to-change-control screening aid
Use this short screen to prompt review. It does not replace the approved SOP, Quality decision, regulatory assessment, or formal impact analysis.
This page tool gives a general prompt only. The company’s approved procedure and qualified reviewers determine the required records and authorization.
Clear answers for practical implementation
Frequently asked questions about change control for CAPA
What is change control for CAPA implementation?
It is the documented process for assessing, approving, planning, executing, and reviewing a controlled change that implements a CAPA action. The CAPA explains the problem and why action is needed; change control governs how the approved solution is introduced.
Does every CAPA require a separate change-control record?
No. Whether a separate change record is needed depends on the site procedure and whether the action changes a controlled state. If formal change control is not required, record the rationale and follow the applicable CAPA, document-control, or other procedure.
When should a CAPA be linked to change control?
Link the records when the approved CAPA action must change a controlled process, equipment, method, material, system, document, facility, supplier arrangement, or validated or registered state and the site procedure requires change control.
What is the difference between CAPA and change control?
CAPA manages the investigation, cause, action rationale, ownership, and effectiveness evaluation. Change control assesses and authorizes the implementation details, impact, prerequisites, approvals, execution evidence, and post-change review.
Who approves a CAPA-driven change?
Required approvers are defined by the site procedure and impact assessment. They commonly include Quality and relevant technical functions, with Regulatory Affairs, Validation, IT, Engineering, or other specialists added when their areas are affected.
Can a CAPA change be implemented before change-control approval?
Normally the proposed change is assessed and approved before routine implementation. An urgent situation should use the documented emergency route, with authorized risk controls and required follow-up; regulatory conditions still apply.
What should the change impact assessment cover?
Assess product and patient risk, process and control strategy, regulatory commitments, validation or qualification, documents and training, computerized systems and data, suppliers, supply transition, affected batches, and the risk of delay.
Is a CAPA risk score enough to approve the change?
No. A score can help prioritize review effort, but it does not replace the impact assessment, supporting evidence, expert judgement, Quality approval, or an independent regulatory decision where needed.
Does every CAPA change require regulatory filing?
No. Regulatory obligations depend on the change, product authorization, and affected jurisdiction. Regulatory Affairs should document the market-specific assessment and any filing, notification, approval, or timing gate before implementation.
When is revalidation needed for a CAPA change?
Revalidation or requalification is determined from intended use, change scope, process knowledge, risk, and the site’s validation procedure. Document the rationale and approved scope, whether additional work is required or the existing state remains acceptable.
Should training be completed before a revised procedure takes effect?
Training should be completed before affected personnel perform work under new instructions when required by the training and change-control procedures. Coordinate document effective dates, training evidence, and cutover controls.
How should an emergency CAPA change be managed?
Use the site’s documented emergency change pathway, including authorized decision-makers, risk assessment, interim or permanent controls, traceable records, required regulatory checks, and the specified follow-up review.
What is the difference between implementation verification and CAPA effectiveness?
Implementation verification confirms that approved tasks and prerequisites were completed as planned. The effectiveness check evaluates whether the action controlled the cause, reduced recurrence risk, and avoided unintended quality effects over justified evidence.
Can the CAPA close before the change-control record?
Close the CAPA only when its procedure’s closure criteria are met and all linked dependencies required to demonstrate action completion and effectiveness are resolved. If the change remains open, document the linkage and follow the site’s approved closure rules rather than assuming approval equals completion.
Can change control close before the CAPA effectiveness check?
It may be possible under a site procedure when implementation and post-change review are complete but CAPA effectiveness needs a longer observation period. Keep the CAPA open or otherwise tracked until its effectiveness criteria and approvals are satisfied.
What should be done when a CAPA change is overdue?
Reassess current product and process risk, interim controls, supply impact, dependencies, and the reason for delay. Record an approved revised plan, owner, due date, and escalation; a date extension by itself does not control risk.
Can one CAPA link to multiple change-control records?
Yes, when an action affects separate systems, sites, products, or work packages that need distinct implementation records. Maintain a clear parent-child map, owners, dependencies, status, and evidence in the CAPA record.
What records should be retained for a CAPA-driven change?
Retain the linked CAPA and change records, cause and risk rationale, impact and regulatory assessments, approvals, implementation plan, validation or testing, controlled document and training evidence, execution results, deviations, effectiveness review, and closure decisions according to record-retention procedures.
What happens if a CAPA effectiveness check fails?
Document the failure, assess ongoing product and process risk, and investigate whether the cause, action design, implementation, or measurement plan was inadequate. Reopen or extend the CAPA through the approved procedure and define further controlled actions.
How should suppliers or contract manufacturers be included?
Assess outsourced process, material, document, quality-agreement, communication, qualification, and regulatory impacts. Assign an owner to confirm external parties receive approved instructions and provide implementation evidence before the change takes effect.
Primary guidance and regulations
References for pharmaceutical change management
Use the current official text and applicable market requirements when making site decisions. Guidance documents provide principles; they do not replace the product authorization, company procedures, or jurisdiction-specific obligations.
This article is an educational overview. Apply the current site procedures, product-specific knowledge, applicable marketing authorization, and jurisdictional requirements. Quality, Regulatory Affairs, and technical specialists should determine the required path for an individual change.
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