Monday, 10 April 2017

Statistical Process Control with Process Capability Analysis

Statistical Process Control

Statistical Process Control

Course "Statistical Process Control with Process Capability Analysis" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Description:
Statistical Process Control is an analytical decision making tool which allows you to see when a process is working correctly and when it is not. Variation is present in any process, deciding when the variation is natural and when it needs correction is the key to quality control.

Statistical Process Control (SPC) is a two-day "hands on" session by Daniel O'Leary - President, Ombu Enterprises, LLC , which will provide an understanding of variation and the associated statistical methods to effectively apply SPC to any process. This course is targeted at practitioners; the concepts and tools are presented during this course are particularly relevant to quality, manufacturing, design, strategic sourcing and operations. During this workshop, participants will learn how to analyze available data and describe a process in statistical terms; establishing an expected range of output performance, based on quantified patterns of variation, in order to both identify when fundamental process changes occur and execute effective process improvements. Participants will learn the SPC tools and techniques applied to identify control limits, understand expected process variation and interpret "out of control" signals in order to proactively take corrective action. Participants will also learn how data derived from SPC can be used to define process capability and how this information can be applied in product design.

Process capability analysis is used to adjust the process until virtually all of the product output meets the specifications. Once the process is operating in control, capability analysis attempts to answer the question: Is the output meeting specifications, or is the process capable? If it is not, can the process be adjusted to make it capable?

What is Process Capability?
1. Process capability is the long term execution level of the procedure after it has been brought under statistical control. In other words, process capability is the range over which the characteristic variety of the procedure occurs as dictated by the arrangement of basic causes.
2. Process capability is likewise the capacity of the blend of individuals, machine, techniques, material, and estimations to deliver an item that will reliably meet the outline prerequisites or client desire.

The capability analysis is carried out in the following steps:
·        Selects the process to be analysed and collection of data;
·        Identify specific limits according to which capability analysis will be evaluated;
·        Verify the process is under statistical control;
·        Analyse data distribution;
·        Estimate capability indices.

Measures of Process Capability Indices:
Cp, Cpl, Cpu, and Cpk are the four most normal and coordinated tried measures of process capability.
• Process capability indices measure how much your procedure produces yield that meets the client's detail.
• Process capability indices can be utilized successfully to abridge process capability data in an advantageous unit less framework.
• Cp and Cpk are quantitative expressions that represent the inconstancy of your procedure (its characteristic limits) with respect to its particular breaking points (client necessities).

Register for the seminar:

Production and Process Control: Building a Robust System

Production Process Control



Two days workshop on:

Date:           31 August 2017 & 01 September 2017
Location:    Boston, MA

During this interactive 2-day workshop, expert instructor, Dan O'Leary, Principal of Ombu Enterprises, will teach you the fundamentals of production and process controls. He will guide you through the fine points using the FDA's own inspection documents coupled with extensive use of Warning Letters to illustrate the issues device manufacturer's face.

Mr. O'Leary will begin by detailing the development of the Quality Management System (QMS), laying the regulatory foundation. He will then teach you how to set up your production system for the life cycle from design transfer to product release to Risk Management production information collection.


Areas Covered

Over the course of two days, instructor will address the following topics:

  •          The role of design output and design transfer
  •          Developing quality plans
  •          Establishing, monitoring, and controlling process parameters
  •          Production equipment including installation, maintenance & effectiveness metrics
  •          Validating production software
  •          Controlling and calibrating measuring equipment including trace-ability
  •          Evaluating and selecting external calibration laboratories
  •          Production changes and when they are also design changes
  •          Determining the process that require validation
  •          Process validation as a statistical issue
  •          Acceptance activities including sampling plans
  •          Nonconforming product and associated corrective action
  •          Risk management (ISO 14971) and production


Register yourself for this brainstorming session now and get special group discounts on registration- Production and Process Control: Building a Robust System



Statistical Techniques for Medical Device Manufacturers

Statistical Techniques for Medical Device Manufacturers

By - Dan O'Leary, President at Ombu Enterprises, LLC on 30 November 2017 & 01 December 2017
Location: San Francisco, CA  

The seminar starts with an understanding of the regulations through a variety of sources. Ex: QSR, ISO 13485:2003, and ISO 13485:2016. Each application of statistical techniques starts with the regulatory requirements and is augmented by the preamble, where FDA addressed the comments it received on the proposed QSR. FDA published an extensive manual to help manufacturers implement the regulations. The seminar analyzes the objectives in the Quality System Inspection Technique (QSIT), the Medical Device Single Audit Program (MDSAP) and then turns to Warning Letters to help understand the methods of regulators.

In addition to statistical methodology, as part of CA & PA information, is required to identity recurring quality problems based on device manufacturers analysis. A similar requirement applies to servicing analysis. The requirement for process validation with a "high degree of assurance" is a requirement for process capability and product characteristics, i.e., a statistical technique.

Upon course completion participants will be able to:
  •         Learn the sections of FDA QSR that require statistical techniques.
  •         Understand how to apply the FDA tools to develop a clear understanding of the requirements.
·*     Regulation
·*     Preamble
·*     Small Entity Compliance Guide
·*     QSIT
·*     Warning Letters
  •       Understand the set of statistical techniques in ISO/TR 10017
  •        Learn how to implement and apply the ISO/TR 10017 statistical techniques.

Register yourself for this brainstorming session Now- Statistical Techniques for Medical DeviceManufacturers