Description

Workshop on Good Documentation Practices for Testing and Calibration Laboratories

Build a Robust Foundation for Laboratory Quality and Compliance

 

In today's quality-driven environment, laboratories are expected not only to generate accurate data but also to maintain comprehensive and traceable records that demonstrate technical validity. Proper documentation forms the backbone of any laboratory's Quality Management System (QMS), playing a pivotal role in ensuring the reliability, reproducibility, and traceability of your results. This intensive workshop is your definitive guide to bridging the gap between everyday record-keeping and a structured documentation system that supports quality assurance, compliance with ISO/IEC 17025:2017, and continual improvement.

 

Actionable Takeaways for Your Job Role

By the end of this workshop, you will be able to confidently:

  • Apply the Fundamentals of Good Documentation Practice (GDP) to ensure clarity, consistency, and accountability in all laboratory records, including ALCOA and ALCOA+ principles for data integrity.
  • Distinguish Between Documents and Records and manage their complete lifecycle from creation to archiving.
  • Develop and Control Documents effectively, including policies, procedures, and work instructions.
  • Record and Maintain Laboratory Data accurately to ensure full traceability and support the validity of your results.
  • Align Your Practices with ISO/IEC 17025:2017 requirements, reducing non-conformities and facilitating accreditation.
  • Overcome Common Documentation Challenges through practical insights and real-world case studies.

 

Quality & Excellence Performance Metrics

Post-training, you will drive these quality parameters to ensure operational excellence in your job-role:

  • Document Control - Successfully review and update 100% of assigned quality documents to ensure alignment with GDP and ISO/IEC 17025:2017 requirements.
  • Record Management - Ensure 100% of sampled laboratory records are complete, legible, and accurately traceable to the original data.
  • Data Integrity - Contribute to achieving zero critical data integrity non-conformities during internal or external assessments in your area of responsibility.
  • Procedure Adherence - Contribute to achieving ≥95% compliance with documented procedures, as verified through process observations and record reviews.
  • Training Competence - Complete a competency evaluation of all assigned personnel on GDP requirements and identify competency gaps with documented recommendations.
  • Corrective Action - Verify ≥90% effectiveness of corrective actions, resulting in 0% recurrence of previously identified documentation non-conformities.
  • Accreditation Readiness - Contribute to achieving zero major nonconformities and minimum numbers of minor nonconformities related to documentation during external assessments.

 

Workshop Curriculum

The workshop is structured into focused modules, designed for immediate application :

  • Module 1: Fundamentals of Good Documentation Practice (GDP) and its Role in the QMS 

  • Module 2: The Document Lifecycle: Creation, Review, Approval, Control, and Obsoleting 

  • Module 3: The Record Lifecycle: Recording, Identification, Storage, Protection, and Retention 

  • Module 4: Documentation Requirements in Key Laboratory Processes (e.g., sampling, testing, calibration, reporting) 

  • Module 5: Practical Case Studies, Common Pitfalls, and Interactive Discussion 

 

Job Roles That Will Benefit

This workshop is essential for all professionals involved in the creation, management, and review of laboratory documentation, including:

  • Quality Managers, Quality Assurance Personnel, and QMS Coordinators

  • Technical Managers, Laboratory Supervisors, and Team Leaders

  • Testing and Calibration Scientists, Technicians, and Analysts

  • Personnel involved in data entry, calculation, verification, and reporting

  • Internal Auditors and personnel preparing for laboratory accreditation

 

Prerequisites

While there are no formal prerequisites, a basic understanding of laboratory operations or quality management standards (like ISO/IEC 17025) is beneficial but not mandatory to maximize learning.

 

Workshop Features & Included Materials

  • Interactive Learning: Engage in practical case studies and group discussions to tackle real-world documentation challenges.
  • Expert-Led Sessions: Learn from experienced instructor and participate in dedicated Q&A sessions.
  • Knowledge Evaluation: Gauge your understanding with Pre and Post-training Self Evaluation.
  • Certificate of Participation: Earn a verifiable, with a unique ID and QR code, soft-copy certificate issued via the QCI training portal. Validate your achievement anytime at https://pathshala.qcin.org/.

 

Enroll Today and Strengthen Your Laboratory's Documentation Backbone!

Invest in your skills to enhance data integrity, achieve compliance, and drive operational excellence within your laboratory.

 

For more information, please contact:

Rohit Varshney at rohit.varshney@qcin.org or call +91 97735 00376