Whittington & Associates Newsletter

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ISO 14001 Family of Standards

Jun 1, 2019 in Newsletter | Comments Off on ISO 14001 Family of Standards

The core standard for the ISO 14001 family of standards is ISO 14001:2015, Environmental management systems – Requirements with guidance for use. To support users of ISO 14001, TC207/SC1 has established four categories of related standards:

Overall Understanding and Implementation

  • ISO 14004:2016, EMS – General guidelines for implementation
  • ISO 14005:2019, EMS – Guidelines for a flexible approach to phased implementation

Evaluating Strategic and Financial Consequences

  • ISO 14007 (due 2019), Environmental management: Determining environmental costs and benefits – Guidance
  • ISO 14008:2019, Monetary valuation of environmental impacts and related environmental aspects

Policy and Organizational Elements

  • ISO 14006 (under revision) Environmental management systems – Guidelines for incorporating ecodesign
  • ISO 14009 (due late 2020) Guidelines for incorporating redesign of products and components to improve material circulation

Evaluating Consequences of Environmental Aspects

  • ISO 14002-1 (due 2020), Guidelines for applying the ISO 14001 framework to environmental aspects and environmental conditions by environmental topic areas
  • ISO 14002-x (TC207/SC1 is considering parts for water and waste)

TC207/SC1 Website

To see how ISO 14001 links to other TC207 standards, view the diagram at the bottom of this web page.

ISO 14005:2019

Jun 1, 2019 in Newsletter | Comments Off on ISO 14005:2019

The second edition of ISO 14005, “Environmental management systems – Guidelines for a flexible approach to phased implementation” has been released.

The document gives guidelines for a phased approach to establish, implement, maintain, and improve an environmental management system (EMS) that organizations, including small and medium-sized enterprises, can adopt to enhance their environmental performance.

The phased approach provides flexibility for organizations to develop their EMS at their own pace, over a number of phases, according to their own circumstances. Each phase consists of six consecutive stages. The number of phases is flexible. This allows organizations to develop the scope, i.e., the activities, products, and services included, and maturity of their EMS, in line with their objectives and available resources.

The phased approach could, for example, start with a project focusing on a specific environmental aspect, such as the use of energy or natural resources. It could also be used to address the needs of a certain interested party, such as a customer requirement, or to manage a specific issue, such as demonstrating legal compliance. The EMS can be expanded over time by progressing through more phases, e.g., to cover more environmental aspects, to systematically address all relevant needs and expectations of interested parties, or to improve environmental performance beyond legal compliance.

The system’s maturity at the end of each phase can be characterized using the five-level maturity matrix provided in Annex A. The matrix is a useful tool to track the achievements of an organization’s environmental objectives and associated benefits and to ensure the efficient use of financial and human resources.

The structure of the maturity matrix incorporates rows that correspond to the different EMS elements, as defined in the clauses of ISO 14001. The columns represent five maturity levels. Each element can be developed incrementally from maturity level 1 through to full maturity in level 5, at which point the element will satisfy the requirements of the respective clause in ISO 14001.

The document is applicable to any organization regardless of their current environmental performance, the nature of the activities undertaken, or the locations at which they occur. The 34-page ISO 14005:2019 standard can be ordered at this ISO web page for about $138.

RCA/CAPA for the Medical Device Industry

Jun 1, 2019 in Newsletter | Comments Off on RCA/CAPA for the Medical Device Industry

We have a new course: Root Cause Analysis and Corrective Action/Preventive Action for the Medical Device Industry. It is available to be taught onsite by the course developer, Duke Okes.

COURSE SUMMARY

A 2-day course consisting of lectures, practices, and role plays that will provide attendees with an in-depth understanding of how to analyze a system in order to identify the root causes of problems. The following topics are covered:

  • The requirements of ISO 13485 and 21-CFR-820 for corrective and preventive action
  • The difference and links between problem solving, root cause analysis and corrective action
  • Five steps for performing the root cause analysis part of problem solving
  • What each step accomplishes and some tools available for carrying it out
  • Solution identification and implementation

COURSE OBJECTIVES

This program is designed to:

  • Understand the role of RCA/CAPA in a QMS as well as the overall process and terminology
  • Provide and practice five steps for deeply analyzing problem situations
  • Demonstrate the steps of solution identification, implementation and follow-up

WHO SHOULD ATTEND

Quality, process and product engineers and technicians, or others responsible for dealing with complaints or technical problems; CAPA coordinators or managers; supervisors, team leaders, and process owners; anyone who wants to improve their ability to solve recurring problems.

PREREQUISITES

None, although familiarity with standard problem-solving models (e.g., PDCA, 8-D, ISO 9001 or other QMS corrective action requirements) and the seven QC tools (flowcharts, cause & effect diagrams, pareto charts, check sheets, run charts, histograms, scatter diagrams) would be useful.

LEARNING OUTCOMES

Participants will learn how to:

  • Differentiate between root cause analysis and CAPA
  • Implement five steps for carrying out effective root cause analysis
  • Select from and apply a variety of tools that support root cause analysis
  • Support and critique root cause analysis carried out by others

INSTRUCTOR

Duke Okes has been helping organizations solve technical problems for more than 30 years. He holds degrees in technology, business and education, is an ASQ Fellow, and is certified by ASQ as a CMQ/OE, CQE and CQA. He is the author of Root Cause Analysis: The Core of Problem Solving and Corrective Action (2nd ed.), Performance Metrics: The Levers for Process Management, and Musings on Internal Quality Audits: Having a Greater Impact.

COURSE OUTLINE
DAY 1

PURPOSE AND PROCESS FOR RCA/CAPA

  • Relative magnitude of 483/WLs in FDA inspections
  • The general CAPA process and sources of data to trigger
  • Needed risk filters in the corrective action process

STEP 1 – PROBLEM DEFINITION

  • Single incident versus trend analysis problem identification
  • Components of a good problem statement
  • Developing a clear and sufficient problem statement (includes practice)

STEP 2 – UNDERSTANDING THE PROCESS

  • How every problem is a process failure
  • How a SIPOC diagram can set boundaries and define interrelationships
  • Using flowcharts to drill down into the right part of the process (includes practice)

STEP 3 – IDENTIFYING POSSIBLE CAUSES

Six ways to identify possible causes

  • Need for input from the right people
  • Logic trees as a cause & effect diagrams/5-whys on steroids (includes practice)

COURSE OUTLINE
DAY 2

STEP 4 – DATA COLLECTION

  • Cause search strategies
  • Records, check sheets, graphs and tables for discrete data collection
  • Surveys, interviews and field observation for opinions or less precise data

STEP 5 – DATA ANALYSIS

  • Tools for discrete data analysis (run charts, histograms, pareto diagram, dot plots, pivot tables)
  • Tools for softer type data (affinity diagram, relationship digraph)
  • Integrative data analysis tools

CONSULTING CASE STUDY PRACTICE

  • Participants role play consulting with instructor on a problem
  • Review of key learning points

HUMAN ERROR

  • Typical causes and solutions for human error
  • Diagnostic techniques for human error
  • Guidance on workstation design to reduce human error

CASE STUDY PRACTICE

  • Practice on a project relevant to participants’ organization

THE REST OF THE PROBLEM-SOLVING PROCESS

  • Identifying, selecting and validating solutions
  • Implementation of corrective and preventive actions
  • Follow-up, signoff and documentation

OTHER FACTORS AFFECTING SUCCESS

CONTACT
For a price quote and to schedule an onsite class, contact Larry Whittington at 770-862-1766 or Larry@WhittingtonAssociates.com.