Action Phrases: Phần 3 – Deviation, Investigation & CAPA

identify a deviation /aɪˈdentɪfaɪ ə ˌdiːviˈeɪʃən/

Phát hiện sai lệch. Example: The operator identified a deviation during production.

report a deviation immediately /rɪˈpɔːrt ə ˌdiːviˈeɪʃən ɪˈmiːdiətli/

Báo cáo sai lệch ngay lập tức. Example: Deviations must be reported immediately.

initiate a deviation record /ɪˈnɪʃieɪt ə ˌdiːviˈeɪʃən ˈrekɔːrd/

Khởi tạo hồ sơ sai lệch. Example: QA initiated a deviation record.

document the deviation /ˈdɒkjʊmənt ðə ˌdiːviˈeɪʃən/

Ghi nhận sai lệch. Example: The deviation was documented.

classify the deviation /ˈklæsɪfaɪ ðə ˌdiːviˈeɪʃən/

Phân loại sai lệch. Example: The deviation was classified as major.

assess the severity /əˈses ðə səˈverəti/

Đánh giá mức độ nghiêm trọng. Example: We assessed the severity.

assess the impact on product quality /əˈses ði ˈɪmpækt ɒn ˈprɒdʌkt ˈkwɒləti/

Đánh giá ảnh hưởng đến chất lượng sản phẩm. Example: We assessed the impact on product quality.

assess patient risk /əˈses ˈpeɪʃənt rɪsk/

Đánh giá rủi ro cho bệnh nhân. Example: Patient risk was assessed.

contain the issue /kənˈteɪn ði ˈɪʃuː/

Kiểm soát sự cố. Example: Immediate actions contained the issue.

implement immediate actions /ˈɪmplɪment ɪˈmiːdiət ˈækʃənz/

Triển khai hành động tức thời. Example: Immediate actions were implemented.

secure the affected material /sɪˈkjʊər ði əˈfektɪd məˈtɪəriəl/

Cô lập nguyên liệu bị ảnh hưởng. Example: We secured the affected material.

quarantine the batch /ˈkwɒrəntiːn ðə bætʃ/

Biệt trữ lô hàng. Example: The batch was quarantined.

place the material on hold /pleɪs ðə məˈtɪəriəl ɒn həʊld/

Đưa nguyên liệu vào trạng thái giữ lại. Example: The material was placed on hold.

stop the operation /stɒp ði ˌɒpəˈreɪʃən/

Dừng hoạt động. Example: We stopped the operation.

notify quality assurance /ˈnəʊtɪfaɪ ˈkwɒləti əˈʃʊərəns/

Thông báo QA. Example: QA was notified immediately.

notify management /ˈnəʊtɪfaɪ ˈmænɪdʒmənt/

Thông báo quản lý. Example: Management was notified.

escalate the issue /ˈeskəleɪt ði ˈɪʃuː/

Báo cáo vấn đề lên cấp cao hơn. Example: The issue was escalated.

collect relevant information /kəˈlekt ˈreləvənt ˌɪnfəˈmeɪʃən/

Thu thập thông tin liên quan. Example: We collected relevant information.

gather supporting evidence /ˈɡæðər səˈpɔːrtɪŋ ˈevɪdəns/

Thu thập bằng chứng hỗ trợ. Example: Supporting evidence was gathered.

review the available data /rɪˈvjuː ði əˈveɪləbl ˈdeɪtə/

Rà soát dữ liệu hiện có. Example: Available data were reviewed.

conduct an investigation /kənˈdʌkt ən ɪnˌvestɪˈɡeɪʃən/

Tiến hành điều tra. Example: A formal investigation was conducted.

lead the investigation /liːd ði ɪnˌvestɪˈɡeɪʃən/

Chủ trì điều tra. Example: QA led the investigation.

assign investigators /əˈsaɪn ɪnˈvestɪɡeɪtərz/

Phân công điều tra viên. Example: Investigators were assigned.

review the sequence of events /rɪˈvjuː ðə ˈsiːkwəns əv ɪˈvents/

Rà soát diễn biến sự việc. Example: We reviewed the sequence of events.

reconstruct the event /ˌriːkənˈstrʌkt ði ɪˈvent/

Dựng lại sự kiện. Example: The event was reconstructed.

interview involved personnel /ˈɪntəvjuː ɪnˈvɒlvd ˌpɜːsəˈnel/

Phỏng vấn nhân sự liên quan. Example: We interviewed involved personnel.

review training records /rɪˈvjuː ˈtreɪnɪŋ ˈrekɔːrdz/

Rà soát hồ sơ đào tạo. Example: Training records were reviewed.

review equipment logs /rɪˈvjuː ɪˈkwɪpmənt lɒɡz/

Rà soát nhật ký thiết bị. Example: Equipment logs were reviewed.

review environmental data /rɪˈvjuː ɪnˌvaɪrənˈmentl ˈdeɪtə/

Rà soát dữ liệu môi trường. Example: Environmental data were reviewed.

review batch documentation /rɪˈvjuː bætʃ ˌdɒkjʊmenˈteɪʃən/

Rà soát hồ sơ lô. Example: Batch documentation was reviewed.

identify the root cause /aɪˈdentɪfaɪ ðə ruːt kɔːz/

Xác định nguyên nhân gốc. Example: We identified the root cause.

determine the root cause /dɪˈtɜːrmɪn ðə ruːt kɔːz/

Xác định nguyên nhân gốc. Example: The root cause was determined.

perform root cause analysis /pəˈfɔːrm ruːt kɔːz əˈnæləsɪs/

Thực hiện phân tích nguyên nhân gốc. Example: Root cause analysis was performed.

apply the five whys method /əˈplaɪ ðə faɪv waɪz ˈmeθəd/

Áp dụng phương pháp 5 Why. Example: We applied the Five Whys method.

use a fishbone diagram /juːz ə ˈfɪʃbəʊn ˈdaɪəɡræm/

Sử dụng sơ đồ xương cá. Example: We used a fishbone diagram.

identify contributing factors /aɪˈdentɪfaɪ kənˈtrɪbjuːtɪŋ ˈfæktərz/

Xác định yếu tố góp phần. Example: Contributing factors were identified.

rule out potential causes /ruːl aʊt pəˈtenʃəl ˈkɔːzɪz/

Loại trừ các nguyên nhân tiềm năng. Example: Potential causes were ruled out.

evaluate possible causes /ɪˈvæljueɪt ˈpɒsəbl ˈkɔːzɪz/

Đánh giá các nguyên nhân có thể. Example: Possible causes were evaluated.

confirm the root cause /kənˈfɜːrm ðə ruːt kɔːz/

Xác nhận nguyên nhân gốc. Example: The root cause was confirmed.

document the root cause /ˈdɒkjʊmənt ðə ruːt kɔːz/

Tài liệu hóa nguyên nhân gốc. Example: The root cause was documented.

evaluate product impact /ɪˈvæljueɪt ˈprɒdʌkt ˈɪmpækt/

Đánh giá ảnh hưởng đến sản phẩm. Example: Product impact was evaluated.

evaluate batch impact /ɪˈvæljueɪt bætʃ ˈɪmpækt/

Đánh giá ảnh hưởng đến lô. Example: Batch impact was evaluated.

assess compliance impact /əˈses kəmˈplaɪəns ˈɪmpækt/

Đánh giá ảnh hưởng đến tuân thủ. Example: Compliance impact was assessed.

assess regulatory impact /əˈses ˈreɡjələtəri ˈɪmpækt/

Đánh giá ảnh hưởng pháp lý. Example: Regulatory impact was assessed.

determine product disposition /dɪˈtɜːrmɪn ˈprɒdʌkt ˌdɪspəˈzɪʃən/

Xác định hướng xử lý sản phẩm. Example: Product disposition was determined.

justify batch release /ˈdʒʌstɪfaɪ bætʃ rɪˈliːs/

Biện minh việc xuất xưởng lô. Example: Batch release was justified.

support the conclusion with data /səˈpɔːrt ðə kənˈkluːʒən wɪð ˈdeɪtə/

Hỗ trợ kết luận bằng dữ liệu. Example: The conclusion was supported with data.

document scientific rationale /ˈdɒkjʊmənt ˌsaɪənˈtɪfɪk ˌræʃəˈnɑːl/

Ghi nhận cơ sở khoa học. Example: Scientific rationale was documented.

reach a justified conclusion /riːtʃ ə ˈdʒʌstɪfaɪd kənˈkluːʒən/

Đưa ra kết luận có cơ sở. Example: We reached a justified conclusion.

finalize the investigation /ˈfaɪnəlaɪz ði ɪnˌvestɪˈɡeɪʃən/

Hoàn tất điều tra. Example: The investigation was finalized.

open a CAPA /ˈəʊpən ə ˈkæpə/

Mở CAPA. Example: A CAPA was opened.

initiate a CAPA /ɪˈnɪʃieɪt ə ˈkæpə/

Khởi tạo CAPA. Example: We initiated a CAPA.

define corrective actions /dɪˈfaɪn kəˈrektɪv ˈækʃənz/

Xác định hành động khắc phục. Example: Corrective actions were defined.

define preventive actions /dɪˈfaɪn prɪˈventɪv ˈækʃənz/

Xác định hành động phòng ngừa. Example: Preventive actions were defined.

assign CAPA ownership /əˈsaɪn ˈkæpə ˈəʊnərʃɪp/

Phân công trách nhiệm CAPA. Example: CAPA ownership was assigned.

establish target dates /ɪˈstæblɪʃ ˈtɑːrɡɪt deɪts/

Thiết lập thời hạn hoàn thành. Example: Target dates were established.

implement corrective actions /ˈɪmplɪment kəˈrektɪv ˈækʃənz/

Triển khai hành động khắc phục. Example: Corrective actions were implemented.

implement preventive actions /ˈɪmplɪment prɪˈventɪv ˈækʃənz/

Triển khai hành động phòng ngừa. Example: Preventive actions were implemented.

track CAPA progress /træk ˈkæpə ˈprəʊɡres/

Theo dõi tiến độ CAPA. Example: CAPA progress is tracked.

monitor CAPA completion /ˈmɒnɪtər ˈkæpə kəmˈpliːʃən/

Theo dõi hoàn thành CAPA. Example: CAPA completion is monitored.

address the root cause /əˈdres ðə ruːt kɔːz/

Giải quyết nguyên nhân gốc. Example: The CAPA addressed the root cause.

eliminate the root cause /ɪˈlɪmɪneɪt ðə ruːt kɔːz/

Loại bỏ nguyên nhân gốc. Example: The CAPA eliminated the root cause.

reduce recurrence risk /rɪˈdjuːs rɪˈkʌrəns rɪsk/

Giảm nguy cơ tái diễn. Example: The CAPA reduced recurrence risk.

prevent recurrence /prɪˈvent rɪˈkʌrəns/

Ngăn ngừa tái diễn. Example: Actions were implemented to prevent recurrence.

improve process robustness /ɪmˈpruːv ˈprəʊses rəʊˈbʌstnəs/

Tăng độ vững chắc của quy trình. Example: The action improved process robustness.

strengthen process controls /ˈstreŋθən ˈprəʊses kənˈtrəʊlz/

Tăng cường kiểm soát quy trình. Example: Process controls were strengthened.

update the procedure /ʌpˈdeɪt ðə prəˈsiːdʒər/

Cập nhật quy trình. Example: The procedure was updated.

revise the SOP /rɪˈvaɪz ði ˌes əʊ ˈpiː/

Sửa đổi SOP. Example: The SOP was revised.

provide additional training /prəˈvaɪd əˈdɪʃənəl ˈtreɪnɪŋ/

Đào tạo bổ sung. Example: Additional training was provided.

enhance operator awareness /ɪnˈhɑːns ˈɒpəreɪtər əˈweənəs/

Nâng cao nhận thức nhân viên. Example: Operator awareness was enhanced.

verify CAPA effectiveness /ˈverɪfaɪ ˈkæpə ɪˈfektɪvnəs/

Xác minh hiệu quả CAPA. Example: CAPA effectiveness was verified.

perform an effectiveness check /pəˈfɔːrm ən ɪˈfektɪvnəs tʃek/

Thực hiện kiểm tra hiệu quả. Example: An effectiveness check was performed.

review post-CAPA data /rɪˈvjuː pəʊst ˈkæpə ˈdeɪtə/

Rà soát dữ liệu sau CAPA. Example: Post-CAPA data were reviewed.

monitor recurrence trends /ˈmɒnɪtər rɪˈkʌrəns trendz/

Theo dõi xu hướng tái diễn. Example: Recurrence trends were monitored.

confirm implementation /kənˈfɜːrm ˌɪmplɪmenˈteɪʃən/

Xác nhận triển khai. Example: Implementation was confirmed.

confirm sustainability /kənˈfɜːrm səˌsteɪnəˈbɪləti/

Xác nhận tính bền vững. Example: Sustainability was confirmed.

review effectiveness results /rɪˈvjuː ɪˈfektɪvnəs rɪˈzʌlts/

Rà soát kết quả hiệu quả. Example: Effectiveness results were reviewed.

close the CAPA /kləʊz ðə ˈkæpə/

Đóng CAPA. Example: The CAPA was closed.

close the deviation /kləʊz ðə ˌdiːviˈeɪʃən/

Đóng sai lệch. Example: The deviation was closed.

document lessons learned /ˈdɒkjʊmənt ˈlesənz lɜːrnd/

Ghi nhận bài học kinh nghiệm. Example: Lessons learned were documented.