NAFDAC Ports Inspection Directorate, Quality Management System

Implementing Quality Management System: The Implications for NAFDAC Ports Inspection

Kayode John Olusola
July 29, 2016

Ports Inspection Directorate
National Agency for Food and Drug Administration and Control (NAFDAC)

Selah! (Pause and Ponder)

  • Quality means doing it right when no one is looking - Henry Ford
  • Quality is not an act, it is a habit - Aristotle
  • Quality is remembered long after the price is forgotten - Gucci
  • Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution; it represents the wise choice of many alternatives - Wiliam Foster

“He Said … … And I Quote”

Presentation Outline

This presentation will highlight Quality Management System (QMS) under the following headers:

  • Introduction
  • QMS Implementation
  • Implications for PID
  • Challenges
  • Recommendations

Introduction

Quality Management System

  • Collection of business processes focused on consistently meeting customer requirements.
  • Organizational structure, policies, procedures, processes and resources needed to achieve customer satisfaction and continual improvement.

ISO 9001

  • Process standard by the International Organization for Standardization that highlights QMS Requirements. - Find list of ISO Standards here

Introduction (Cont'd)

ISO 9001 only requires that, at a minimum, QMS be rationalized and articulated by:

  • A Quality Manual
  • 6 Documented Procedures
    • Document Control
    • Record Control
    • Control of Non-Conforming Product (or Service)
    • Internal Audits
    • Corrective Action
    • Preventive Action
  • At least 21 Records - Find list here

QMS: Implementation

A quite popular perspective to Quality Management System Implementation reads:

  • Say What You Do (Have Quality Procedures)
  • Do What You Say (Follow the Procedures)
  • Record What You Did (Keep Quality Records)
  • Prove It (Check the Results)
  • Improve It (Act on the Differences)

Implement QMS: Say What You Do

  • Quality Policies (Quality Manual) and Procedures (SOPs)
  • Quality Manual (follow link for detail guidelines)
    • Manual should discuss purpose, quality system, policy, programs, objectives, definitions, management, procedures and plans
    • Manual should have manageable sections such as Title, Table of Contents, Scope, Overview, Quality Policy, Quality Objectives, Organizational Structure, Index etc.
    • Develop and document distribution and change control of manual, SOPs and supporting document
  • Standard Operating Procedures (SOPs) - Provide concise document for each core process - Understand the full process, then use a user friendly document format - Make the document revision process as easy as possible.

Implement QMS: Do What You Say

  • Having SOPs don't guarantee that activities are actually performed effectively, efficiently or even consistently.
  • SOPs cannot replace motivated and competent employees who work within a well-designed process.
  • Implementing QMS requires amongst other things:
    • Commitment of top management to set priorities in appropriate resource allocation during the design and implementation.
    • Commitment of all the employees of the organization to use procedures, forms, equipment and instructions are in the way it was planned.

Implement QMS: Record What You Did

To prove that you “do what you say”, keep and control RECORDS!

  • Document: information and its supporting medium
  • Record: document stating results achieved or providing evidence of activities performed
  • In simple terms, “Documented Procedure” tells how to do specific things, and “Record” is the proof that those specific things were done and what the results were.

Examples of Records:

  • Minutes of meetings
  • Training records
  • Internal Audits
  • Non-conformances
  • Corrective actions
  • Preventive actions etc.

Implement QMS: Prove It

  • QMS results reported against process success criteria should be checked at regular intervals.
  • Evaluate QMS with Management Review meetings to assess QMS against Strategic Objectives, Process Success Criteria and Process Standard such as ISO 9001.
  • Review perceived customer satisfaction.
  • Perform Internal Audits to identify areas for improvement, or possibly complacency with an outside set of eyes and always act on the report to improve the process.

Note: Follow link to view more details on Internal Audit

Implement QMS: Improve It

  • Identify Non-conformance
    • A product/service that doesn't meet requirements - internal, customer, statutory or regulatory.
  • Apply Corrective Actions (Reactive)
    • Actions taken to resolve a non-conformance AND to ensure that there is no reoccurrence.
  • Take Preventive Actions (Proactive)
    • Action to eliminate the occurrence of potential non-conformance or minimize the effect if it ever occurs.

Implement QMS: Implications for PID


  • Quality Manual
    • Who are our Clients?
    • What Products/Services do we offer?
    • What is our Quality Policy?
  • Documented Procedure
    • What are PID core processes?
    • Do we have control processes for documents and records?
    • Can we identify some non-conformances?
    • Any CAPA in place?

Implement QMS: Challenges

  • Bad attitudes/Abdication of responsibility
  • Deficiency of cultural dynamism
  • Inadequate resources for total quality management
  • Lack of effective measurement of quality improvement
  • Lack of management commitment
  • Resistance of the workforce
  • Inadequate Human Resource Development
  • Poor planning
  • Lack of customer focus

Implement QMS: Recommendations

Implement QMS: Recommendations

WHERE DO YOU STAND?

Implement QMS: Recommendations

WHERE DO YOU STAND?
“If you feel like it’s difficult to change, you will probably have a harder time succeeding.” Andrea Jung

Questions?



Please Take Note

Find this Presentation Online at:

http://rpubs.com/jkayode/qms