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. By focusing on the complete lifecycle of documents and records, as well as key data integrity principles including ALCOA+, you will gain the knowledge to enhance operational excellence, reduce non-conformities, and prepare for successful accreditation assessments.

 

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 .

  • Distinguish Between Documents and Records and manage their complete lifecycle, from creation and review to archiving and disposal .

  • Develop and Control Documents effectively, including policies, procedures, and work instructions, ensuring they are approved, reviewed, uniquely identified, and accessible at points of use .

  • 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 by mastering the controls for management system documents (Clause 8.3) and records (Clause 8.4), thereby reducing non-conformities and facilitating accreditation .

  • Overcome Common Documentation Challenges through practical insights and real-world case studies, including the application of ALCOA+ principles for data integrity .

 

Quality & Excellence Performance Metrics

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

  • Successfully map existing documentation systems to the ISO/IEC 17025:2017 requirements.

  • Thoroughly identify all gaps against the clauses for document control (8.3) and record control (8.4).

  • Plan and implement robust document and record management processes.

  • Update all critical documents, including quality manuals, SOPs, and work instructions, to reflect best practices.

  • Implement a system to ensure that only the current versions of documents are available at points of use.

  • Proactively integrate ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) into laboratory documentation practices .

  • Investigate and correct common documentation-related non-conformities, preventing recurrence.

 

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, it is highly recommended that participants have a basic understanding of laboratory operations or quality management standards (like ISO/IEC 17025) to maximize their learning from this workshop.

 

Workshop Features

  • Focused Content: Concentrate on the specific requirements for document control and record keeping in testing and calibration laboratories.

  • Interactive Sessions: Engage in practical case studies and group discussions to tackle real-world documentation challenges .

  • Expert-Led Sessions: Learn from experienced instructors and participate in dedicated Q&A sessions.

  • 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 with ISO/IEC 17025:2017, and drive operational excellence within your laboratory.

 

For more information, please contact:

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