Part 1 of 4: How to Create a Quality Control Plan for Business providing Management Guidelines and Practical Steps
Some plain talk about an implementation process that often sounds complicated. We’ll show and tell how to create a quality control plan with 10 management guidelines and 12 practical steps.
The process map shown below displays quality control plan procedure numbers ranging from QMS-00 through QMS-17.
To see for yourself how quality system documents establish policies for your Company, follow along with this guide for how to create a quality control plan.
After logging-in to eQMS, click/tap QMS procedure numbers in the process map shown below to open and browse corresponding quality system procedures. If you’re using a smartphone or tablet, enlarge the process map to make it easier to access links to QMS documents. Some of the blocks in the process map contain more than one link.
The process map is optimized for display on desktops, laptops, tablets and smartphones in landscape mode.
Quality System Process Map for Key Business Processes
Guide to How to Create a Quality Control Plan
Top Level Policies and Procedures
The following titles were extracted from the above flowchart, which displays applicable quality system procedure numbers.
Documents named QMS-00 through QMS-17 are a family of documents that establish the foundation of a modern quality control system, which succinctly describes how to create a quality control plan.
1) Business Plans and Objectives, QMS-00 Quality Manual. Select the manual that applies to your business.
The quality manual is designed to describe “what to do” and summarizes Company policies and procedures that are approved by top level management. The “how to’s” are described in procedures and forms that are referenced in the quality manual.
2) Management Review, QMS-04 Management Process Procedure.
Perform an initial management review and organize the workplace using the 5S methodology to optimize conditions for your quality improvement project.
Top management representatives need to sign an Engineering Order to document and authorize creation of your new quality control system. To see a typical EO to create and authorize a quality control system, click here then select item number 1 in the pulldown menu named “Field Value”.
If your Company is at ground zero regarding how to create a quality control plan, start with the management review meeting form and complete the agenda items.
Browse this typical implementation schedule to learn more about how much time is needed to complete the improvement initiative.
3) Responsibilities and Authorities, QMS-05 Responsibilities and Authorities Procedure.
Our guide for how to create a quality control plan recommends you define two Company organization charts. Make one for inclusion in the quality manual that only displays the title of each position and make another that adds employee names. The organization chart with names and titles needs to be revision controlled.
The quality manual is designed to describe “what-to-do” and QMS procedures are designed to provide details about “how-to-do”. Tailor your quality manual and definitions and abbreviations procedure to match your Company’s terminology.
5) Resource Needs, Personnel and Skills, Infrastructure and Information Technology, Facilities, Equipment and Maintenance, Resources, QMS-04 Management Process Procedure.
Fill-out the management review meeting form to address gaps in your Company’s resource management.
Part 1 in this series for how to create a quality control plan will help your Company establish the foundation for its quality control system.
Guide to how to create a quality control plan continued…
Part 2 of 4: Continuous Improvement Tool for Documenting Progress of your Company’s Quality Control Plan
The request for support form is the most effective continuous improvement tool in a quality control plan:
Request for Support Form
Reasons why the Request for Support form is so versatile:
- It focuses attention on a problem or condition that should be solved or clarified,
- It gives permission to discuss what is known with decision makers that can make the job easier and more rewarding,
- It is the tool that continuously improves people, products, Customer confidence and good Suppliers,
- It involves people in the decision-making process,
- It reinforces the resolve to do things right,
- It informs and communicates without restriction,
- It provides an historical record of actions to prevent re-learning what is already known,
- It standardizes procedures and consolidates efforts so all are working towards the same goal,
- It moves the point of focus from finger-pointing to serious decision-making,
- It makes good practices better!
Top Level Policies and Procedures continued:
6) Product and QMS Data, QMS-03 Records Control Procedure.
Control records according to the Records Control procedure. Management of records is a cost burden for all businesses and finding a way to easily control records can be a daunting task. Registrars and Auditors recommend digital storage of records to simplify their jobs. We agree because electronic records simplify things for everyone in the Company.
7) Control of Nonconformances, QMS-14 Control of Nonconformances Procedure.
Document and process nonconformances according to the Control of Nonconformances procedure using the Request for Support form. The RFS form is very flexible to document continuous improvement opportunities, calculated risks and nonconformances.
A suggestion as part of our how to create a quality control plan is to use the heading on the RFS record to sort each type of RFS and use the data to create three quality system performance metrics:
- Continuous Improvement
- Calculated Risk
We always say, “Its amazing what you find when you start looking!”, and these metrics will really open your eyes to how to create a quality control plan that takes care of the business.
8) Corrective and Preventive Action, QMS-13 Corrective and Preventive Action Procedure.
Document and process corrective and preventive actions according to the Corrective and Preventive Action procedure using form Request for Support. The RFS is used to process internal corrective and preventive actions and the ICAR form is used to correspond with Suppliers.
9) Internal Audits, QMS-12 Internal Auditing Procedure.
Document and perform internal audits according to the Internal Audits procedure using internal audit forms. Use internal audits to focus attention on problem areas then complete a Request for Support to document observations, findings and corrective actions. Follow-through is important to confirm effectiveness of actions.
Update archived records from the past 6 months of completed contracts to bring them into compliance with new quality program requirements. The updated records enable internal Auditors to confirm compliance with new Company policies and procedures.
10) Customer Satisfaction, QMS-04 Management Process Procedure.
Part 2 in this series for how to create a quality control plan establishes Customer satisfaction as a standard agenda item in the Management Process procedure.
Send a Customer Satisfaction Survey form to all Customers but don’t worry if they don’t return the form because there are other methods that top management uses to determine Customer satisfaction. The goal is to forward the information to a management meeting for processing.
Guide to how to create a quality control plan continued…
Part 3 of 4: Contract Review Form for Integrating Customer Requirements into your Company’s Quality Control System
The contract review form will help your Company understand and integrate Customer requirements into your business operation.
Contract Review Form
Practical Steps for Business and Production Operations
1) RFQ and Quote, QMS-07 Proposal Development and Contract Review Procedure.
QMS-07 is applicable for a request for quote from your Customer to review requirements before your Company receives an order. Browse the procedure then open and complete the Contract Review form. We strongly suggest that all fields in forms be completed as a critical part of our how to create a quality control plan. Insert “N/A” or “—” (without quotes) into all fields that are supposed to be blank.
We recommend transfer of all “paper” records to an electronic or database-driven format to simplify records control as part of our how to create a quality control plan. This means any form in your business operation is a candidate for “temporary-use document” because you’ll later transfer data to a permanent electronic or database-driven form. Watermark or identify temporary-use paper forms with the word “Notepad” to confirm the fact that the “temporary paper” form does not need to be stored. This will save considerable effort and money because your Company is not saving paper records.
2) Order Processing and Contract Review, QMS-07 Proposal Development and Contract Review Procedure.
QMS-07 also applies after you receive a contract from your Customer. Browse the procedure then complete the Contract Review form. No blank fields allowed! Remember, you can use a watermarked “Notepad” paper form then later transfer data to an electronic or database-driven form to eliminate the expense of storing paper records.
3) Design and Development (and Requisitions), QMS-17 Design and Development Procedure, QMS-01 Document Control Procedure, QMS-02 Configuration Management Procedure, QMS-08 Purchasing Procedure.
QMS-17 applies to contracts that require your Company to develop new products or services. Browse QMS-17 and periodically complete a dedicated Design Review form. QMS-01 controls documents created during the design phase and QMS-02 controls document revisions using an Engineering Order. QMS-08 controls purchase of goods and services needed for the design phase using a Purchase Order form.
Remember, our guide for how to create a quality control plan enables all “paper” forms to be watermarked or designated as a “Notepad” to convert them to a “temporary-use document” when you later transfer data to an electronic or database-driven form. This means after you transfer data to your permanent form, you can dispose of the “paper” form to eliminate the cost of records storage, which is a notable achievement for any quality control system.
3.1) Specs, Plans, Instructions, QMS-01 Document Control Procedure.
Create new specifications, plans and work instructions then control the documents according to QMS-01.
3.2) Calibration, QMS-15 Calibration Procedure.
Calibrate measuring equipment used for development and testing of new products or services using the Calibration Report form. Rinse and repeat for all equipment used to accept or reject deliverable products and services.
3.3) New Product Tests and Results, QMS-03 Records Control Procedure.
Retain and store “paper” test records according to QMS-03. Our guide for how to create a quality control plan does not address engineering requirements for creation of specifications, plans, work instructions or applicable test and inspection forms because that information is proprietary to your Company.
3.4) Nonconformances (and Improvement Opportunities), QMS-14 Control of Nonconformances Procedure.
Document all nonconformances and opportunities for improvement according to QMS-14 using the Request for Support form.
4) Scheduling Requirements, QMS-07 Proposal Development and Contract Review Procedure.
Use your favorite software program to create a schedule or complete the Contract Review form to report your production start and end dates.
5) Purchasing, QMS-08 Purchasing Procedure.
5.1) Material Requests, QMS-08 Purchasing Procedure.
Some contracts impose complex flowdown requirements that need a Responsible Authority to review “requisitions for materials”. According to our guide for how to create a quality control plan, in most cases, purchase order review and approval by signature or stamp is enough for compliance to eliminate review of requisitions.
5.2) Approved Suppliers, QMS-08 Purchasing Procedure.
Review and approve all Suppliers whose product or service goes into your Company’s deliverables using the Supplier Evaluation form. Of course, your Company policy could flowdown compliance with ISO 9001, or at least the check marked items in our MS Office document named Supplier Quality Requirements.
5.3) Purchase Orders, QMS-08 Purchasing Procedure.
Create purchase orders using the Purchase Order form. All purchase orders for supplies and services that go into your Company’s deliverables need to be reviewed and display approval by a Responsible Authority. Purchase orders for non-deliverable items are exempt from review when applying the conditions of our guide for how to create a quality control plan.
6) Receiving, QMS-09 Receiving Procedure.
Receive and process supplies through receiving inspection according to the Receiving procedure using forms named Daily Receiving Log and Receiving Log. Non-deliverable supplies are exempt from formal inspection and are processed through “Receiving” according to documented Company policies. Finalize Supplier approval using form named Supplier Evaluation. Our guide for how to create a quality control plan suggests your Company uses Supplier performance as a metric and send Suppliers a periodic report using a Supplier Performance Rating spreadsheet.
6.1) Nonconformances (and Improvement Opportunities), QMS-14 Control of Nonconformances Procedure.
Use the Request for Support form to document findings and observations from the receiving process. Use form named Investigation and Corrective Action Request form to correspond with Suppliers.
Part 3 in this series for how to create a quality control plan will help your Company document objective evidence records that demonstrate how deliverable supplies are controlled.
Guide to how to create a quality control plan continued…
Part 4 of 4: Production Inspection Form for Documenting Status of Deliverable Supplies
The production inspection form is used to report the status of deliverable supplies during the production process.
Production Inspection Form
Practical Steps for Business and Production Operations
7) Inventory Management, QMS-09 Receiving Procedure.
Production supplies are processed through receiving inspection then released to the stockroom with applicable identification.
8) Calibration, QMS-15 Calibration Procedure.
Calibrate measuring equipment used for acceptance or rejection of deliverable products or services using the Calibration Report form. Rinse and repeat for all equipment used to accept or reject your Company’s products and services.
9) Production, QMS-10 Production Procedure.
Open the “build” procedure if your Company produces items according to Customer requirements.
Open the “design” procedure if your Customers buy your products according to your design.
Open the “service” procedure if your Company provides a service.
Perform production operations according to the Production procedure using forms named Production Inspection and/or Freeform IIS. Our guide for how to create a quality control plan suggests your Company uses a Routing Ticket form and/or QC tag(s) or more comprehensive form(s) (e.g., traveler) to identify the status of deliverable items during the production process.
9.1) Nonconformances (and Improvement Opportunities), QMS-14 Control of Nonconformances Procedure.
Document all nonconformances and opportunities for improvement according to the Control of Nonconformances procedure using the Request for Support form. Our guide for how to create a quality control plan suggests standardized application of the RFS form because it has more capability than an old-traditional nonconformance report form. The RFS form should be used by all employees to document their suggestions, concerns, observations and way-to-go comments, which makes the RFS form a simple “request for support” until the request has been processed by the MRB.
10) Product Tests and Results, QMS-03 Records Control Procedure.
Perform inspections and/or tests to accept or reject deliverable products and services and control records according to the Records Control procedure. Use acceptable results to validate successful performance of your design and/or production process using form named Verification and Validation form.
11) Shipping, QMS-11 Shipping Procedure.
Perform the shipping process according to the Shipping procedure and form named Shipping form. Our guide for how to create a quality control plan suggests your Company assigns a member of your team to become a packaging expert or at least become familiar with ASTM D3951 Standard Practice for Commercial Packaging.
12) Customer Complaints, Customer Assessments, Product Returns (and Improvement Opportunities), QMS-14 Control of Nonconformances Procedure.
Create records of improvement opportunities from Customer satisfaction surveys and feedback using form named Request for Support form. Our guide for how to create a quality control plan suggests your Company processes all Customer feedback records according to the Management Review procedure using form named Management Review form.
Part 4 in this series will help your Company document compliance with quality system requirements from Dock-to-Stock through Production and Shipping (and Customer feedback).
We know that every quality system standard can be implemented, operated and maintained using the “do-it-yourself” methodology for how to create a quality control plan.
After completing the above steps, measure your Company’s compliance using the quality systems assessment form. Take some time to address observations and findings then confirm and document their closure. Your Company is now ready to assert compliance with your chosen quality system standard or begin the certification process.