Part 1 of 4: How to Create a Quality Control Plan for Business providing 100’s of Editable Templates, Best Practices, Management Guidelines and Practical Steps.
Some plain talk about a 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.
Follow along with this guide for how to create a quality control plan to browse documents that establish Company policies and procedures.
See quality management system procedure numbers in the following flowchart. Notice that some procedures apply to key product realization processes.
Quality System Flowchart for Key Product Realization Processes
Guide to How to Create a Quality Control Plan
Top Level Policies and Procedures
Documents named QMS-00 through QMS-17 are a family of documents that establish the foundation of a modern quality control system.
1) Business Plans and Objectives, QMS-00 Quality Handbook.
The quality manual is designed to summarize Company policies and describe “what to do”. The “how to’s” are referenced by procedure number in the quality manual.
2) Management Review, QMS-04 Management Process Procedure.
We recommend your management team perform an initial review to begin the improvement project.
Top management representatives need to sign a Change Order to create or update the quality control system. The Change Order is evidence that changes to QMS docs are revision controlled.
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 a 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 organization chart for inclusion in the quality manual that only displays the title of each position. Make another chart that adds employee names. The organization chart with names needs to be revision controlled.
4) Policies, Directions and Definitions, QMS-00 Quality Handbook and QMS-16 Definitions and Abbreviations.
The quality manual summarizes Company policies (what to do) and QMS procedures provide details about “how to” apply policies. Tailor the quality manual and definitions and abbreviations procedure to integrate your Company’s terminology.
5) Resource Needs, Personnel and Skills, Infrastructure and Information Technology, Facilities, Equipment and Maintenance, Resources, QMS-04 Management Process Procedure.
Complete the Management Review Meeting Form to mitigate gaps in resource management.
Organize the workplace using the 5S methodology to engage everyone in the new quality control plan.
Part 1 in this series for how to create a quality control plan will help any Company establish a foundation for its quality management system.
Guide to how to create a quality control plan continued…
Part 2 of 4: Continuous Improvement Tool for Documenting Progress of a Company’s Quality Control Plan
The Request for Support Form is the most effective continuous improvement tool in the quality control plan:
Request for Support Form
The Request for Support Form is very effective because it:
- Focuses attention on a problem or condition that should be solved or clarified,
- Gives permission to discuss what is known with decision makers that can make the job easier and more rewarding,
- Informs and communicates without restriction,
- Is a tool that continuously improves people, products, Customer confidence and good Suppliers,
- Involves people in the decision-making process,
- Makes good practices better,
- Moves the point of focus from finger-pointing to serious decision-making,
- Provides historical records of actions to prevent re-learning what is already known,
- Reinforces the resolve to do things right,
- Standardizes procedures and consolidates efforts so all are working towards the same goal!
Top Level Policies and Procedures continued:
6) Product and QMS Data, QMS-01 Control of Documented Information Procedure.
We recommend control of records according to the Control of Documented Information Procedure. Most methods of controlling paper records are expensive. Registrars and Auditors recommend digital storage of records. We agree, because electronic records simplify continuous improvement efforts.
7) Control of Nonconformities, QMS-14 Control of Nonconformities Procedure.
Process and document nonconformities according to the Control of Nonconformities Procedure using the Request for Support Form. The RFS Form is very flexible to document continuous improvement opportunities. In addition, the RFS can be used as a calculated risk release and to help clarify requirements.
A suggestion as part of our how to create a quality control plan is to use the heading on the RFS Form to sort records into quality system performance metrics:
- Nonconformance
- Continuous Improvement
- Calculated Risk
We always say, “Its amazing what you find when you start looking…!” And, “Performance metrics work to maintain a quality control plan that continuously improves.”
8) Corrective Action, QMS-13 Corrective Action Procedure.
Document and process corrective actions according to the Corrective Action Procedure using the Request for Support Form. The RFS is used to process internal corrective actions. We recommend using the Investigation and Corrective Action Request Form to control Supplier corrective actions.
9) Internal Audits, QMS-12 Internal Auditing Procedure.
Document and perform internal audits according to the Internal Audits Procedure using the Internal Audit Form. Use internal audits to find and fix gaps in compliance. Complete a Request for Support Form to document observations, findings and corrective actions. Follow-through is important to confirm effectiveness of actions.
If your Company has been in business for a while but is just starting its QMS, consider updating at least six (6) months of archived records. The updated records will enable Auditors to confirm compliance with new Company policies and procedures.
10) Customer Satisfaction, QMS-04 Management Process Procedure.
Our guide to 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. Top management uses many methods to determine Customer satisfaction. The goal is to forward survey information to a management meeting for processing.
Guide to how to create a quality control plan continued…
Part 3 of 4: Contract Review Form
The Contract Review Form helps a Company to understand and integrate Customer requirements into the business operation.
Contract Review Form
1) RFQ and Quote, QMS-07 Proposal Development and Contract Review Procedure.
The Proposal Development and Contract Review procedure helps to translate a Customer’s request for quote. The form is designed to enable review of requirements before a Company receives an order. Browse the procedure then open and complete the Contract Review Form. We recommend all fields in the form be completed. Insert “N/A” or “- – -” (without quotes) into all fields that remain blank.
To simplify records control, we recommend conversion of all “paper” records into an electronic or database-driven format. The benefit of electronic data is that it can be accessed at the same time by multiple resources.
In practice, almost any form in the business can be a “temporary-use document”. This means the User can dispose of the paper record after it is scanned and stored. Consider assigning the data entry task to a person that is detail and numbers oriented. Use the scanned copy as referee to correct transposition errors.
We recommend displaying a watermark or the term “Notepad” on “temporary-use forms”. The savings are considerable because the Company is not storing and managing paper records.
2) Order Processing and Contract Review, QMS-07 Proposal Development and Contract Review Procedure.
The Proposal Development and Contract Review procedure also applies after receipt of a contract. Browse the procedure then complete the Contract Review Form. Remember, no blank fields! Consider using a watermarked or “Notepad” paper form then later transfer data to an electronic or database-driven form. The process helps to eliminate the expense of storing paper records.
3) Design and Development (and Requisitions), QMS-17 Design and Development Procedure, QMS-01 Control of Documented Information Procedure, QMS-02 Configuration Management Procedure, QMS-08 Purchasing Procedure.
The Design and Development procedure applies to contracts that require development of new products or services. Browse the Design and Development Procedure and periodically complete a dedicated Design Review Form. The Configuration Management Procedure controls documents created during the design phase. The Procedure also controls document revisions using a Change Order. The Purchasing Procedure 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”.
After a User transfers data to the permanent form, they can dispose of the “paper” form to eliminate the cost of records storage. This is a notable achievement for any quality control system.
3.1) Specs, Plans, Instructions, QMS-01 Control of Documented Information Procedure.
Create new specifications, plans and work instructions then control the documents according to the Control of Documented Information Procedure.
3.2) Calibration, QMS-15 Calibration Procedure.
Calibrate measuring equipment used for development and testing of products or services using the Calibration Report Form. Repeat for all equipment used to accept or reject deliverable products and services.
3.3) New Product Tests and Results, QMS-01 Control of Documented Information Procedure.
Retain and store “paper” test records according to the Procedure and/or scan records for electronic storage.
3.4) Nonconformities (and Improvement Opportunities), QMS-14 Control of Nonconformities Procedure.
Document all nonconformities and opportunities for improvement according to the Control of Nonconformities Procedure 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 and 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, review and signature approval of the Purchase Order eliminates review and approval of requisitions.
5.2) Approved Suppliers, QMS-08 Purchasing Procedure.
Review and approve all Suppliers whose product or service goes into deliverables using the Supplier Evaluation Form. Of course, a Company could require Suppliers to be compliant with ISO 9001 or other industry standards. If those standards are too much, flowdown applicable requirements from 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 are used in 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 Record 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 using Supplier performance as a metric. Send Suppliers a periodic report using the Supplier Performance Rating Spreadsheet.
6.1) Nonconformities (and Improvement Opportunities), QMS-14 Control of Nonconformities Procedure.
Use the Request for Support Form to document findings and observations from the receiving process. Use the 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 any Company create 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
The Production Inspection Form is used to report the status of deliverable supplies during the production process.
Production Inspection Form
7) Inventory Management, QMS-09 Receiving Procedure.
Purchased 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. Repeat for all equipment used to accept or reject products and services.
9) Production, QMS-10 Production Procedure.
Perform production operations according to the Production Procedure using the Production Inspection Form. Our guide for how to create a quality control plan suggests a Company use a Routing Ticket Form and/or QC tags or more comprehensive form(s) (e.g., traveler) to identify the status of deliverable items during the production process.
9.1) Nonconformities (and Improvement Opportunities), QMS-14 Control of Nonconformities Procedure.
Document all nonconformities and opportunities for improvement according to the Control of Nonconformities 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. These actions make the RFS Form a simple “request for support” until the request has been processed by the MRB.
10) Product Tests and Results, QMS-01 Control of Documented Information Procedure.
Perform inspections and/or tests to accept or reject deliverable products and services. Control records according to the Procedure. Use acceptable results to validate successful performance of the design and/or production process using the Verification and Validation Form.
11) Shipping, QMS-11 Shipping Procedure.
Perform the shipping process according to the Shipping Procedure and form named Shipping Log. Our guide for how to create a quality control plan suggests a Responsible Authority be assigned 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 Nonconformities Procedure.
Create records of improvement opportunities from Customer Satisfaction Surveys and feedback using the Request for Support Form.
Our guide for how to create a quality control plan suggests processing all Customer feedback records according to the Management Process Procedure using the Management Review Meeting Form.
Part 4 in this series will help any 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 its chosen quality system standard or begin the certification process.