How to Set Up a Quality Assurance System

This guide presents a sample quality control system closely prepared from one developed by a fortune 500 company. It may be used as a guide in initiating your own quality assurance system, whether you sell to consumers, industrial users, or government.

All quality and inspection systems have simple, basic elements in common:

Organization - setting and assigning specific authority and responsibility for each phase of the system;

Quality Planning - writing work instructions with realistic "defect prevention" rules, looking at manufac­turing processes for possible quality trouble spots, set­ting acceptance/rejection standards, controlling ac­cepted/rejected products, and setting up a means of us­ing suppliers' and customers' failure information to im­prove product quality;

Product Specification Control - making sure everyone always has the latest technical data for properly produc­ing, inspecting, and shipping the product;

Supplier Product Quality Control - watching purchases to make sure that the people you buy from know and observe your quality requirements as well as technical specifications;

Measurement and Test Equipment Control - setting up a system to insure that such equipment is properly and regularly calibrated to established standards;

Nonconforming Material Control - spotting defects as early in production as possible and keeping faulty items from reaching customers; and

Records and Reports - setting up a system that tracks all steps of the production, inspection, and shipping cy­cle to identity existing and potential problem areas.

The following sample manual incorporates these basics. It may be adapted to fit your needs. It is recommended that each section of a manual you work up be on a loose-leaf sheet for easy reference and revision. Remember, the best manual in the world won't do any good unless every employee - not just those in Quality Assurance - is convinced that producing quality pro­ducts is of prime importance.

A Sample Manual

Introduction

This manual describes for our employees and customers our quality control system. The system applies both to the items we produce and to the items we buy from our suppliers.

As dictated by the complexity of product design, manufacturing techniques used, and customer requirements, more specific written procedures may be required to implement the policies set in this manual.

No changes may be made to this manual or any supplementary quality control procedures unless approved by the plant manager or an authorized representative.

Table of Contents

Description / Section

Scope - 1.0

Responsibilities - 2.0

Purchase Order Control - 3.0

Drawing and Specification Change Control - 4.0

Receiving Inspection - 5.0

Raw Material Control - 6.0

In Process Inspection - 7.0

Assembly Inspection and Functional Testing - 8.0

Final Inspection and Testing - 9.0

Faulty (Discrepant) Material Control - 10.0

Tool and Gage Control - 11.0

Overrun Stock Control - 12.0

Packing and Shipping - 13.0

Identification - 4.0

Appendix A Organization Chart -

Appendix B Purchase Order Form

Appendix C Inspection Data Form -

(Each company should use its own forms for the Appendices).

Appendix D Identification Tags

Appendix E Travel Card

1.0   Scope

1.1   The quality control system includes: receiving, iden­tifying, stocking and issuing parts and material; all manufacturing processes; packing, storing; and ship­ping.

1.2   The system is designed to ensure customer satisfac­tion through quality control management of supplies made and services performed here, and by our sup­pliers at their facilities. It is designed to spot process­ing problems early so we can correct them before we've produced a lot of faulty items.

1.3   Written inspection and test procedures will be prepared to supplement drawings and other specifica­tions, as necessary.

2.0   Responsibilities

2.1 The supervisor of quality assurance reports directly to the plant manager.

2.2 The quality assurance supervisor's responsibilities in­clude:

2.2.1 Planning how to meet customer's quality requirements

2.2.2 Reviewing customer drawings and specifications.

2.2.3  Determining inspection points.

2.2.4  Writing inspection and test instructions.

2.2.5  Establishing (and making sure employees follow) the most effective and efficient quality assurance pro­cedures possible.

2.2.6 Keeping adequate quality assurance records.

2.2.7 Reviewing quality assurance records and overseeing follow-up for correction and prevention of defects.

2.2.8 Assuring that our suppliers' quality control and follow-up are adequate.

2.2.9 Inspecting all special and standard gages, test equip­ment, and tooling used to manufacture products when we acquire them and calibrating them on a regularly scheduled basis.

2.2.10  Coordinating in-plant correction of items rejected by customers, explaining to customers what action will be taken, and evaluating the actions for effectiveness.

2.2.11   Making sure inspectors make unbiased decisions to accept or reject items.

3.0  Purchase Order Control

 3.1  All of our purchase orders to suppliers must be ap­proved by the plant manager or an authorized representative.

3.2  When the purchase order is released, our buyer will send our supplier all required drawings, specifica­tions, and other customer requirements (such as material or process certifications, physical or chemical analysis, source inspections) with the pur­chase order.

3.3 If there is a drawing or specification change after our order is placed with the supplier, our buyer will send the supplier a purchase order change, including our latest Engineering change and the latest drawings or other specifications.

3.4 Copies of all purchase orders will be kept on file for our customers to review.

4.0 Drawing and Specification Change Control

4.1 We manufacture to customer drawings and specifications. Sets of these are filed in job number folders in Production Control files.

4.2 Production Control is responsible for charging out and keeping track of drawings and specifications.

4.3 The Sales Department receives Engineering changes from our customers and is responsible for sending these changes to Production Control immediately.

4.4 Production Control is responsible for issuing the latest Engineering changes, drawings, and specifications of departments that need them and for voiding outdated Engineering changes, drawings, and specifications.

4.5 A standard procedure will be set up to control changes by effective date or serial/lot number.

5.0 Receiving Inspection

5.1 All parts and materials will be received and logged in by the Receiving Department.

5.2 All parts and materials will be sent to Receiving Inspection after logging in.

5.3 Receiving Inspection will assure that proper certification, physical and chemical test data, special process certifications, or source inspection certifications are with the items to be inspected.

5.4 The receiving inspector must document the complete results of all inspection and tests.

5.5  Inspection will identify accepted lots and send them to stock.

5.6  Rejected lots will be identified and set aside in Receiv­ing Inspection until the buyer and Production Control decide on disposition.

5.7  The Receiving Department will send a copy of each rejection report to the Purchasing Department and the supplier.

5.8  The Purchasing Department has the responsibility of assuring that a pattern of continually receiving faulty items from any supplier doesn't develop and assuring supplier corrective action.

5.9  The Quality Department will follow-up to see that a supplier who has sent us items we reject has effective­ly corrected what it has been doing wrong.

5.10 Receiving Inspection instructions will be written with consideration given to the complexity of the parts, material received, and customer requirements. Follow customer instructions (if any) for inspection.

5.11 Sample according to customer requirements (if any).

5.12 The Quality Department will review Receiving Inspec­tion records periodically to see if any suppliers are consistently failing to meet standards.

5.13 All inspection records will show the number in­spected, the number rejected, and the name of the in­spector.

5.14  Inspection records will also show the disposition of supplier-provided records and data.

 

 

Everyone needs To be knowledgeable about the Decision Making Process. All of us rely on advice, and techniques or tools, to help
us in our everyday lives.

When we head out To eat, the restaurant menu is the tool which provides us with all the information required to choose what to
purchase and how much to invest.

Running a Business also needs making conclusions using techniques and information - how much inventory to preserve, what price to
sell it at, what credit arrangements to offer, how many people to hire.

Decision Making Process in company is the systematic procedure for identifying and solving problems, of asking questions and
finding answers. Decisions usually are made under conditions of uncertainty. The future is not understood and sometimes even the
last is suspect. This manual opens the door for company owners and managers to learn about the selection of techniques that can be
used to improve your decision making process in a world of uncertainty, change, and uncontrollable conditions.

A General Approach to Decision Making Process. If or not a scientist, or an executive of a significant company, or a small
business owner you can benefit from boosting your decision making abilities. The general solution to systematically solving
problems is exactly the same. The next 7 step approach to enhance management decision making may be utilized to study nearly all
issues faced by a business enterprise.

State that the problem. A issue first has to exist and be recognized. What is the issue and why is it a issue. What's perfect and
how can current operations vary from that ideal. Describe why the symptoms (what's going wrong) and the triggers (why is it going
wrong). Try to define all terms, theories, factors, and relationships. Quantify the problem to the extent possible. If the issue,
not accurately and quickly filling customer orders, then try to ascertain how many orders were incorrectly filled and how long it
took to fill them.

Define the Objectives. What are the objectives of the analysis. Which goals are the most critical. Objectives are said by means of
an action verb like to reduce, to increase, or to improve. Returning to the customer dictate problem, the major objectives would
be: 1) to increase the percentage of orders filled correctly, and 2) to decrease the time necessary to order and process. A
sub-objective could include to simplify and streamline the order filling procedure.

Develop a Diagnostic Framework. Next set a diagnostic frame, that is, determine what methods are going to be used, what types of
information are needed, and also how and where the information is available. Is there going to be a customer survey, a summary of
company documents, time and motion tests, or some thing else. What are the assumptions (facts supposed to be correct) of the
analysis. Which are the criteria used to evaluate the study. What time, funding, or other constraints are there. What kind of
qualitative or other special techniques will be used to analyze the information. (Some of that will be covered shortly). In other
words, the diagnostic framework establishes the extent and processes of the whole study.

Collect and Assess the Data. The next step is to collect the information (by following the methods created in Step 3. Raw
information is then tabulated and organized to ease analysis. Tables, charts, graphs, indicators and matrices are a number of the
standard ways to organize raw data. Analysis is your critical prerequisite of sound business decision making. What does the data
reveal. What facts, patterns, and trends could be viewed from the data. Many of the qualitative methods covered below may be used
during the step to ascertain facts, patterns, and trends in data. Obviously, computers are used widely in this step.

Generate Alternative Solutions. After the analysis was finished, some specific decisions about the character of the issue and its
resolution should have been achieved. The next step is to create alternative solutions to this problem and position them in order
of the net benefits. But how are alternatives best generated. Again, there are some well established techniques like the Nominal
Group Method, the Delphi Method and Brainstorming, among others. In all these methods that a team is included, all people who have
reviewed the data and analysis. The approach is to have an informed group suggesting many different possible solutions.

Grow an Action Plan and Implement. Pick the best solution to this problem but be certain to understand clearly why it's best,
which is, how it accomplishes the goals established in Step 2 greater than its alternatives. Then develop an effective method
(Action Plan) to execute the solution. At this point a significant organizational thought arises - who is going to be accountable
for seeing the implementation through and what authority does he have. The chosen manager ought to be responsible for seeing that
all of tasks, deadlines, and reports are performed, fulfilled, and composed. Details are all important in this step: schedules,
reports, tasks, and communication will be the key elements of any action plan. There are several techniques available to decision
makers implementing an action plan. The PERT method is a method of laying out an whole interval like an action program. PERT will
be covered shortly.

Evaluate, Acquire Feedback and Monitor. Following the Action Plan has been implemented to Solve a issue, management has to
evaluate its own effectiveness. Assessment Standards have to be determined, feedback channels developed, and observation
performed. This Step should be done after 3 to 5 weeks and at 6 months. The goal is to answer the bottom line question. Has the
issue been solved?

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