Part 3: Deviation, Investigation, OOS, CAPA

deviation

/ˌdiːviˈeɪʃən/

Sai lệch.

Example: A deviation was initiated immediately after the event.

planned deviation /plænd ˌdiːviˈeɪʃən/

Sai lệch có kế hoạch. Example: The planned deviation was approved before execution.

unplanned deviation /ʌnˈplænd ˌdiːviˈeɪʃən/

Sai lệch không kế hoạch. Example: An unplanned deviation occurred during compression.

critical deviation /ˈkrɪtɪkəl ˌdiːviˈeɪʃən/

Sai lệch nghiêm trọng. Example: A critical deviation requires immediate escalation.

major deviation /ˈmeɪdʒər ˌdiːviˈeɪʃən/

Sai lệch lớn. Example: The deviation was classified as major.

minor deviation /ˈmaɪnər ˌdiːviˈeɪʃən/

Sai lệch nhỏ. Example: The issue was classified as a minor deviation.

event /ɪˈvent/

Sự kiện. Example: The event was documented in detail.

incident /ˈɪnsɪdənt/

Sự cố. Example: The incident was reported to QA.

occurrence /əˈkɜːrəns/

Sự xảy ra. Example: This was the first occurrence of the issue.

reporting /rɪˈpɔːrtɪŋ/

Báo cáo. Example: Timely reporting is required.

notification /ˌnəʊtɪfɪˈkeɪʃən/

Thông báo. Example: QA received immediate notification.

escalation /ˌeskəˈleɪʃən/

Báo cáo cấp cao hơn. Example: Escalation followed company procedures.

investigation /ɪnˌvestɪˈɡeɪʃən/

Điều tra. Example: An investigation was initiated promptly.

investigator /ɪnˈvestɪɡeɪtər/

Người điều tra. Example: The investigator reviewed all records.

investigation report /ɪnˌvestɪˈɡeɪʃən rɪˈpɔːrt/

Báo cáo điều tra. Example: The investigation report was approved.

fact finding /fækt ˈfaɪndɪŋ/

Thu thập sự kiện. Example: Fact finding was completed before analysis.

timeline /ˈtaɪmlaɪn/

Dòng thời gian sự kiện. Example: The timeline was reconstructed accurately.

evidence /ˈevɪdəns/

Bằng chứng. Example: Supporting evidence was available.

objective evidence /əbˈdʒektɪv ˈevɪdəns/

Bằng chứng khách quan. Example: Objective evidence supported the conclusion.

interview /ˈɪntəvjuː/

Phỏng vấn. Example: Operators were interviewed during the investigation.

statement /ˈsteɪtmənt/

Bản tường trình. Example: A written statement was obtained.

observation /ˌɒbzəˈveɪʃən/

Quan sát. Example: Observations were documented carefully.

finding /ˈfaɪndɪŋ/

Phát hiện. Example: The finding was supported by evidence.

conclusion /kənˈkluːʒən/

Kết luận. Example: The conclusion was scientifically justified.

impact assessment /ˈɪmpækt əˈsesmənt/

Đánh giá ảnh hưởng. Example: Impact assessment showed no quality risk.

product impact /ˈprɒdʌkt ˈɪmpækt/

Ảnh hưởng đến sản phẩm. Example: No product impact was identified.

quality impact /ˈkwɒləti ˈɪmpækt/

Ảnh hưởng chất lượng. Example: Quality impact was assessed.

patient risk /ˈpeɪʃənt rɪsk/

Rủi ro cho bệnh nhân. Example: Patient risk was considered.

risk evaluation /rɪsk ɪˌvæljuˈeɪʃən/

Đánh giá rủi ro. Example: Risk evaluation was documented.

risk level /rɪsk ˈlevəl/

Mức độ rủi ro. Example: The risk level was low.

root cause /ruːt kɔːz/

Nguyên nhân gốc. Example: The root cause was identified.

root cause analysis /ruːt kɔːz əˈnæləsɪs/

Phân tích nguyên nhân gốc. Example: Root cause analysis was performed.

direct cause /dəˈrekt kɔːz/

Nguyên nhân trực tiếp. Example: The direct cause was equipment failure.

contributing factor /kənˈtrɪbjuːtɪŋ ˈfæktər/

Yếu tố góp phần. Example: Several contributing factors were identified.

human error /ˈhjuːmən ˈerər/

Lỗi con người. Example: Human error was not the root cause.

procedural gap /prəˈsiːdʒərəl ɡæp/

Lỗ hổng quy trình. Example: A procedural gap was identified.

equipment failure /ɪˈkwɪpmənt ˈfeɪljər/

Hỏng thiết bị. Example: Equipment failure caused the deviation.

system failure /ˈsɪstəm ˈfeɪljər/

Lỗi hệ thống. Example: The issue resulted from system failure.

5 Whys /faɪv waɪz/

Phương pháp 5 Why. Example: The 5 Whys method was used.

fishbone diagram /ˈfɪʃbəʊn ˈdaɪəɡræm/

Biểu đồ xương cá. Example: A fishbone diagram supported the analysis.

CAPA /ˈkæpə/

Hành động khắc phục và phòng ngừa. Example: CAPA was opened after investigation.

corrective action /kəˈrektɪv ˈækʃən/

Hành động khắc phục. Example: Corrective action addressed the issue.

preventive action /prɪˈventɪv ˈækʃən/

Hành động phòng ngừa. Example: Preventive action reduced recurrence risk.

action plan /ˈækʃən plæn/

Kế hoạch hành động. Example: An action plan was approved.

due date /djuː deɪt/

Ngày hoàn thành. Example: CAPA due dates were monitored.

owner /ˈəʊnər/

Người chịu trách nhiệm. Example: A CAPA owner was assigned.

implementation /ˌɪmplɪmenˈteɪʃən/

Triển khai. Example: CAPA implementation was completed.

effectiveness check /ɪˈfektɪvnəs tʃek/

Kiểm tra hiệu quả. Example: An effectiveness check was performed.

effectiveness verification /ɪˈfektɪvnəs ˌverɪfɪˈkeɪʃən/

Xác minh hiệu quả. Example: Effectiveness verification was successful.

recurrence /rɪˈkʌrəns/

Tái diễn. Example: No recurrence has been observed.

repeat deviation /rɪˈpiːt ˌdiːviˈeɪʃən/

Sai lệch lặp lại. Example: Repeat deviations trigger escalation.

trend analysis /trend əˈnæləsɪs/

Phân tích xu hướng. Example: Trend analysis identified recurring issues.

OOS /ˌəʊ əʊ ˈes/

Kết quả ngoài tiêu chuẩn. Example: An OOS investigation was initiated.

out of specification /aʊt əv ˌspesɪfɪˈkeɪʃən/

Ngoài tiêu chuẩn. Example: The result was out of specification.

OOT /ˌəʊ əʊ ˈtiː/

Ngoài xu hướng. Example: The result was classified as OOT.

out of trend /aʊt əv trend/

Ngoài xu hướng. Example: Out-of-trend results require evaluation.

laboratory investigation /ləˈbɒrətri ɪnˌvestɪˈɡeɪʃən/

Điều tra phòng thí nghiệm. Example: Laboratory investigation was completed first.

manufacturing investigation /ˌmænjuˈfæktʃərɪŋ ɪnˌvestɪˈɡeɪʃən/

Điều tra sản xuất. Example: Manufacturing investigation identified no issues.

analyst error /ˈænəlɪst ˈerər/

Lỗi kiểm nghiệm viên. Example: Analyst error was ruled out.

sampling error /ˈsɑːmplɪŋ ˈerər/

Lỗi lấy mẫu. Example: Sampling error was investigated.

testing error /ˈtestɪŋ ˈerər/

Lỗi thử nghiệm. Example: Testing error was not identified.

assignable cause /əˈsaɪnəbl kɔːz/

Nguyên nhân xác định được. Example: An assignable cause was found.

invalid OOS /ɪnˈvælɪd ˌəʊ əʊ ˈes/

OOS không hợp lệ. Example: The OOS was invalidated with justification.

confirmed OOS /kənˈfɜːrmd ˌəʊ əʊ ˈes/

OOS xác nhận. Example: The OOS result was confirmed.

retest /ˌriːˈtest/

Thử nghiệm lại. Example: Retesting followed approved procedures.

resample /ˌriːˈsɑːmpl/

Lấy mẫu lại. Example: Resampling was scientifically justified.

laboratory error /ləˈbɒrətri ˈerər/

Lỗi phòng thí nghiệm. Example: No laboratory error was found.

scientific justification /ˌsaɪənˈtɪfɪk ˌdʒʌstɪfɪˈkeɪʃən/

Cơ sở khoa học. Example: Scientific justification was documented.

decision tree /dɪˈsɪʒən triː/

Cây quyết định. Example: The OOS decision tree was followed.

containment action /kənˈteɪnmənt ˈækʃən/

Hành động ngăn chặn. Example: Containment actions were implemented immediately.

interim action /ˈɪntərɪm ˈækʃən/

Hành động tạm thời. Example: Interim actions reduced immediate risk.

permanent action /ˈpɜːrmənənt ˈækʃən/

Hành động vĩnh viễn. Example: Permanent actions addressed the root cause.

escalation matrix /ˌeskəˈleɪʃən ˈmeɪtrɪks/

Ma trận báo cáo. Example: The escalation matrix was followed.

quality review board /ˈkwɒləti rɪˈvjuː bɔːrd/

Hội đồng xem xét chất lượng. Example: The case was reviewed by the quality review board.

management review /ˈmænɪdʒmənt rɪˈvjuː/

Xem xét của lãnh đạo. Example: Significant deviations were presented during management review.

lessons learned /ˈlesənz lɜːrnd/

Bài học kinh nghiệm. Example: Lessons learned were shared across departments.

knowledge sharing /ˈnɒlɪdʒ ˈʃeərɪŋ/

Chia sẻ kiến thức. Example: Knowledge sharing prevented recurrence.

continuous improvement /kənˈtɪnjuəs ɪmˈpruːvmənt/

Cải tiến liên tục. Example: Continuous improvement is encouraged.

quality risk management /ˈkwɒləti rɪsk ˈmænɪdʒmənt/

Quản lý rủi ro chất lượng. Example: Quality risk management supported decision-making.

ICH Q9 /ˌaɪ siː eɪtʃ kjuː naɪn/

Hướng dẫn quản lý rủi ro chất lượng. Example: The assessment followed ICH Q9 principles.

documentation /ˌdɒkjʊmenˈteɪʃən/

Tài liệu hóa. Example: Documentation was complete and accurate.

justification /ˌdʒʌstɪfɪˈkeɪʃən/

Giải trình. Example: A written justification was provided.

approval /əˈpruːvəl/

Phê duyệt. Example: QA approval was obtained.

closure /ˈkləʊʒər/

Đóng hồ sơ. Example: The deviation was closed after effectiveness verification.

open action /ˈəʊpən ˈækʃən/

Hành động chưa hoàn thành. Example: Open actions were tracked weekly.

overdue CAPA /ˌəʊvərˈdjuː ˈkæpə/

CAPA quá hạn. Example: Overdue CAPAs were escalated.

quality metric /ˈkwɒləti ˈmetrɪk/

Chỉ số chất lượng. Example: CAPA effectiveness is a quality metric.

KPI /ˌkeɪ piː ˈaɪ/

Chỉ số hiệu suất chính. Example: Investigation cycle time is a KPI.

cycle time /ˈsaɪkəl taɪm/

Thời gian xử lý. Example: Investigation cycle time was reduced.

on-time closure /ɒn taɪm ˈkləʊʒər/

Đóng đúng hạn. Example: On-time closure exceeded the target.

quality culture /ˈkwɒləti ˈkʌltʃər/

Văn hóa chất lượng. Example: A strong quality culture encourages reporting.

speak up culture /spiːk ʌp ˈkʌltʃər/

Văn hóa lên tiếng. Example: Employees are encouraged to report issues.

data review /ˈdeɪtə rɪˈvjuː/

Rà soát dữ liệu. Example: Data review identified discrepancies.

record review /ˈrekɔːrd rɪˈvjuː/

Rà soát hồ sơ. Example: Record review supported the investigation.

evidence-based /ˈevɪdəns beɪst/

Dựa trên bằng chứng. Example: Conclusions must be evidence-based.

scientific approach /ˌsaɪənˈtɪfɪk əˈprəʊtʃ/

Cách tiếp cận khoa học. Example: Investigations require a scientific approach.

robust investigation /rəʊˈbʌst ɪnˌvestɪˈɡeɪʃən/

Điều tra chặt chẽ. Example: Inspectors expect a robust investigation.