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Quality Systems

 

 

General

Managing quality is part of every company’s day-to-day business. Deciding whether or not to implement and maintain a quality system is in part based on legislative requirements, the clientele, other codes and requirements, or simply the internal drive to manage quality in a reputable and auditable manner. Regardless of the motivation, it is an investment, supporting the company’s performance, goals and strategies.

Defining the scope of a particular quality system can be a rather complex process. For instance, if an organization needs or wants to comply with CFR (USA) requirements, ASME (B&PV Code or BPE), or European Directives, makes a difference in the scope and depth of the implementation.

Contrary to the ASME PV&B Code, do European Directives (EU Laws) provide choices with respect to the scope of a quality system? The choices are related with the hazard rating and hence classification of a particular product, type approval or product family. Combining system requirements, reviewing all existing documents, and making sure that all requirements are fulfilled leads to a system that finds recognition internally, and with clientele and legal authorities.

Portfolio

ECE Global provides quality system services related to all levels of implementation, expansion or maintenance. Basic Portfolio:

New Systems

Expanding Systems

Maintaining Systems

Policy Definition
Gap Identification Support
Internal Audits
Implementation *
Implementation *
Documentation Validation
Auditing
Auditing
Identifying Improvements
Certification *
Certification *
Implementation Support

* We cannot implement and certify, because it creates a conflict of interest. Please note that we do have a corporate agreement with DNV, who could act as an independent certification body.

Something about Systems

Systems are everywhere and affect every aspect of our lives.  Businesses are simply an example of a system. They are complex systems that are created to add value to the world around them, particularly for direct stakeholders:

  • Shareholders want a return on investment
  • Employees want a sense of worth, fair wages and a safe working environment
  • The local and global community want minimized impact and appropriately managed waste arising from products and byproducts
  • Customers want their needs determined, fulfilled and delivered upon (timing, price and performance)
  • Suppliers want to understand their role in the supply chain so they can fulfill their customers' needs

To accomplish this task, businesses use a Management System to determine these stakeholder needs, translate the needs into internal requirements, provide the necessary resources, fulfill the requirements, review performance to improve and continually repeat the cycle.

Sounds simple in theory, but as we all know from running or participating in businesses, the complexity of the real world makes this much more difficult. Many of the problems facing companies today stem from the need to get tasks completed and leading to somewhat anti-systemic thinking. Often this is related to complex systems, too many steps to complete a simple task, etc. To avoid this pitfall, our job is to define your organization as a system, necessary to:

  1. Fulfill stakeholder requirements
  2. Drive continual improvement of the system (and not just localized improvement)

Understanding system complexity is essential to effectively managing a system.

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What is a Management System?

Management Systems are the collection and interrelation of parts that convert business needs into satisfied stakeholders, employees, clientele and legal authorities. From the very first day of business--regardless of whether a 3rd generation family restaurant, a small agency or a 100,000 person multinational corporation, every organization has a management system. However, it may not be defined so that it can be relied upon to run the business.

A management system consists of four essential parts:

  • Policy and objectives to guide the organization
  • Responsibilities defined so that people know what is expected
  • Defined processes linking people to business objectives
  • Data shared and analyzed to improve the performance of the company and meet pertinent requirements

  • Policy is a mandate from top managers to inspire the use of the system. Objectives are what drive people and processes so the organization knows what is expected:

    • Business objectives are requirements for the "here and now"
    • Strategic objectives are requirements for the desired "future state"
    • Process objectives are the requirements that must be met to achieve the business and strategic objectives

  • Defining responsibilities often extends far beyond organizational charts and job descriptions. It includes organizational structure and culture and addresses questions such as:
    • Who is responsible for understanding needs and establishing objectives?
    • Who has authority for designing and planning the execution of processes?
    • How are processes resourced and controlled?
    • How do leaders inspire teams to control and improve processes to satisfy the needs and objectives by using and improving the system?

  • Processes make up the largest "part" of a management system and often receive the most focus. Processes apply resources and controls to convert inputs into outputs that satisfy internal and external staff organizations. Processes exist at many levels within an organization with distinct relationships between each level:
    • Level 0: Needs to cash
    • Level 1: Get Work > Do Work > Get Paid
    • Level 2: Marketing > Selling > Designing > Producing > Delivering > Servicing
    • Level 3: Value streams specific to products or customers
    • Level 4: ...

    A well-defined process must identify the critical inputs, resources and controls (X's) necessary to fulfill objectives (Y's) and must be documented sufficiently to ensure control.

  • Data are the records we use to show how well the system is fulfilling requirements and objectives.
    • Analyzed data becomes information
    • Information understood by people and teams becomes knowledge
    • Knowledge leads to wisdom through informed decision making

We should only collect data necessary for decision making and determining if objectives are met. All else is waste. However, knowing exactly what to collect is often difficult, particularly if your management system is not developed. Collecting and storing too much data is not usually costly, given the ever lessening cost of electronic data storage tools. However, not collecting the right data is costly. Developing a management system includes analyzing processes to determine the measurement and data collection points necessary for an effective system.

Every organization is unique, so while every company has a management system that consists of these four elements, no two management systems are alike. That is why:

  • Every company must develop their own system so it can be used and improved, and
  • Management systems cannot be bought, downloaded or created by consultants - every company must do it for themselves (of course, sometimes with the help of a consultant!). Be wary of people selling "canned" solutions - you often get what you pay for.

A well-developed management system is the tool all in the organization use to communicate the interdependency of people, processes and the system and make informed decisions affecting profitability.

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Industry Experience & Clientele

Industry Experience
Biotech & Pharmaceutical

Owner / Operator / OEM / A&E of:

Plants

Skids & Modules

Pressure Equipment

Piping Systems

Materials & Components

Food & Beverage
Petroleum
Chemical
Energy
Rail Equipment

 

 

 

 

 

 

 

 

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