Quality control plans are often viewed as a set of instructions that should be followed. They document the planning, implementation, and assessment procedures for a project, as well as any QA or QC activities. Some areas may be more detailed than others, based on the project, process, or organization’s needs.
A quality plan is a document, or several documents, that together specify quality standards, practices, resources, specifications, and the sequence of activities relevant to a particular product, service, project, or contract. Quality plans should define:
Objectives to be attained (for example, characteristics or specifications, uniformity, effectiveness, aesthetics, cycle time, cost, natural resources, utilization, yield, dependability, and so on)
Steps in the processes that constitute the operating practice or procedures of the organization
Allocation of responsibilities, authority, and resources during the different phases of the process or project
Specific documented standards, practices, procedures, and instructions to be applied
Suitable testing, inspection, examination, and audit programs at appropriate stages
A documented procedure for changes and modifications to a quality plan as a process is improved
A method for measuring the achievement of the quality objectives
Other actions necessary to meet the objectives
At the highest level, quality goals and plans should be integrated with overall strategic plans of the organization. As organizational objectives and plans are deployed throughout the organization, each function fashions its own best way for contributing to the top-level goals and objectives.
At lower levels, the quality plan assumes the role of an actionable plan. Such plans may take many different forms depending on the outcome they are to produce. Quality plans may also be represented by more than one type of document to produce a given outcome.
Elements of a Strategic Quality Plan
Quality Plan Example
An example of a quality plan is a manufacturing company that machines metal parts. Its quality plan consists of applicable procedures (describing the production process and responsibilities), applicable workmanship standards, the measurement tolerances acceptable, the description of the material standards, and so forth. These may all be separate documents.
More variable information that pertains to a particular customer may be spelled out on individual work orders (sometimes called travelers). Work orders specify the machine setups and tolerances, operations to be performed, tests, inspections, handling, storing, packaging, and delivery steps to be followed.
An operating-level quality plan translates the customer requirements (the what) into actions required to produce the desired outcome (the how) and couples this with applicable procedures, standards, practices, and protocols to specify precisely what is needed, who will do it, and how it will be done. A quality control plan may specify product tolerances, testing parameters, and acceptance criteria. While the terminology may differ, the basic approach is similar for service and other types of organizations.
How to Write a Quality Plan
Quality assurance or quality control plans evaluate and/or modify an organization’s procedures to help ensure they provide the desired results. Quality control plans are often viewed as a set of instructions that should be followed. They document the planning, implementation, and assessment procedures for a project, as well as any QA or QC activities.
Some areas may be more detailed than others, based on the project, process, or organization’s needs. It is important to note that each plan is unique based on the organization’s needs and their quality management system (QMS). However, quality control plans should always have a structure that permits improvements to the plan. This allows employees to offer input on how to improve efficiency and quality. In addition, the plan should be reviewed by others periodically, including stakeholders, to ensure the plan is comprehensive.
Three Elements of a Quality Plan
Quality control plans generally include detailed information on:
An overview or introduction of the project or process detailing the background, need, scope, activities, and important dates or deadlines
The organizational structure or org chart detailing necessary team members, including external vendors
Each team member’s responsibilities and qualifications necessary to fulfill stated duties
Work verification (e.g., who is responsible for carrying out a task, as well as who is responsible for checking the work)
Supplier standards (e.g., specify the standards the prospective suppliers must meet before they can bid on a contract, such as ISO 9001:2015)
A list of qualified suppliers
Testing parameters
Performance standards and how performance will be documented
Acceptance criteria
Deliverables
A feedback mechanism for internal and/or external customer feedback
Quality control procedures
Training (e.g., overview, job-specific, or refresher training)
Corrective action and preventive actions, including the person(s) responsible for CAPA
Suggested corrective action
Required notifications
Any references or related materials, including performance ratings or performance reports
Quality Plan Documentation and Deployment
Quality plans result from both deployed strategic quality policies (which are linked to organizational strategic plans) and from the specific legal regulations, industry standards, organization policies and procedures, internal guidelines, and good practices needed to meet customers’ requirements for products or services.
Strategic-level quality plans are developed and deployed through the strategic planning process. These broad-based quality plans become the guideline for each function’s or department’s supporting quality plan. Where appropriate, each function or department may develop and internally deploy operating-level quality plans.
Operating-level quality plans often are the resulting document(s) from a production scheduling function. As such, this documentation often includes blueprints, a copy of the customer’s order, references to applicable standards, practices, procedures, and work instructions, and details on how to produce the specific product or service.
When the product or service is produced, the planning documents may be augmented by inspection documentation, statistical process control (SPC) charts, and copies of shipping documents and customer-required certifications. In the process, the plans are transformed from documents to records. In a fully computerized system, the documents mentioned may well be interactive computer screens accessed at operators’ workplaces and control points. These screens, internally, become records when operators, inspectors, shippers, and others make computer entries to the screens.
A completed set of matrices, developed by a quality function deployment (QFD) process, may fulfill a component of an organization’s quality plan. The purpose of QFD is to capture and deploy the customers’ needs and requirements throughout the organization.
Documenting the quality plan(s) has multiple uses, such as:
Ensuring conformance to customer requirements
Ensuring conformance to external and internal standards and procedures
Facilitating traceability
Providing objective evidence
Furnishing a basis for training
Together with multiple plans for the organization’s products, services, and projects, providing a basis for evaluating the effectiveness and efficiency of the quality management system (QMS).
Adapted from The Certified Manager of Quality/Organizational Excellence Handbook, ASQ Quality Press.
Quality Templates and Excel Tools
Box and whisker plot (Excel) This graphical plotting tool goes beyond the traditional histogram by providing you with easy-to-read displays of variation data from multiple sources, for more effective decision making.
Check sheet (Excel) Use this simple, flexible tool to collect data and analyze it with histogram and Pareto charts.
Control chart (Excel) See how a control chart tracks process change over time, and create your own.
Design of experiments (DOE) (Excel) This powerful tool helps you see the effect multiple input factors can have on a desired output (response), exposing important interactions that may be missed when experimenting with one factor at a time.
Failure Mode and Effects Analysis (FMEA) (Excel) Use this template to evaluate the potential failure of a product or process and its effects, and then identify actions that could eliminate or reduce the occurrence of the potential failure.
Fishbone (cause-and-effect) diagram (Excel) Analyze process dispersion with this simple, visual tool. The resulting diagram illustrates the main causes and subcauses leading to an effect (symptom).
Flowchart (Excel) Create a graphical representation of the steps in a process to better understand it and reveal opportunities for improvement.
Gantt chart (Excel) This tool can be used in process planning and control to display planned tasks and finished work in relation to time.
Histogram (Excel) Analyze the frequency distribution of up to 200 data points using this simple—but powerful—histogram generating tool.
Pareto chart(Excel) Use this quick and very basic tool to capture and analyze problem occurrences.
Relations diagram checklist, template, and template instructions (DOCs and PDF) Mainly used to identify logical relationships in a complex and confusing problem situation, the strength of an interrelationship diagram is its ability to visualize such relationships. The process of creating an interrelationship diagram can help groups analyze the natural links between different aspects of a complex situation.
Scatter diagram(Excel) This tool shows the relationship between an input, X, and the output, Y. If a relationship exists, the input is correlated to the output.
Stratification diagram (Excel) Analyze data collected from various sources to reveal patterns or relationships often missed by other data analysis techniques. By using unique symbols for each source, you can view data sets independently or in correlation to other data sets.
Quality Tools in Healthcare
Case Studies and Articles
The following examples show how these quality tools and templates can be used in a healthcare setting.
What's the Plan? (Quality Progress) When ER-One of Livonia, Michigan, needed to transition the management of newly acquired hospital emergency departments to its organization, it turned to advanced implementation quality planning (AIQP).
Development and Implementation of a New Process for Handling Add-On Lab Orders at Duluth Clinic–Ashland (PDF)Read a case study that includes a control plan created at SMDC Health System’s Duluth Clinic—Ashland Laboratory as part of a successful project to improve the handling of add-on laboratory test orders.
Tip of the Iceberg (Quality Progress) Heartland Health’s iceberg is a pyramid that depicts the vision of the organization, a Baldrige Award recipient, and illustrates its bottom-up, holistic approach to healthcare.
Taking Process Improvement Beyond the Quality Department(PDF) Team improvement projects are key to process improvement at Genesis Health System (GHS), who shares its road map for bringing together key stakeholders and process owners in kaizen blitz teams.
Lean Nursing (PDF, Quality Engineering) A case study demonstrates the use of lean Six Sigma to reduce length of stay for patients with total hip replacements while at the same time reducing costs.
Jersey Score (Quality Progress) Baldrige recipient AtlantiCare's 5Bs framework aims to make the organization the best in five areas: quality, customer service, people and workplace, growth, and financial performance.
A Dose of DMAIC (Quality Progress) Hospital pharmacy's use of process capability studies as part of a Six Sigma and lean effort to improve wait times, efficiency, and patient flow.
Get the Whole Picture (Quality Progress) Two healthcare programs used systems thinking, which helps you analyze how multiple processes fit together and work in tandem, to improve service to patients, save money, and cut waste.
Additional Tools and Templates
The following include a template and additional methods to use in a healthcare setting.
Employee instruction sheet (XLS) Use this employee instruction sheet, submitted by Matthew Bommarito, to capture the components of process documentation on one comprehensive worksheet. The downloadable spreadsheet includes separate tabs with instructions, a template, and an example from Heartland Regional Medical Center, St. Joseph, MO.
Force field analysisForce field analysis is based on the assumption that any situation is the result of forces for and against the current state being in equilibrium. Countering the opposing forces and/or increasing the favorable forces will help induce a change.
Impact effort matrixThe impact effort matrix provides answers to the question of which solutions seem easiest to achieve with the most effects.
Problem concentration diagramA problem concentration diagram helps you connect events to physical locations, thus perhaps revealing patterns of occurrence.
Purpose and applications of interrelationship diagrams Relations diagrams can help you identify relationships in a complex or confusing problem situation.
SIPOC+CM diagramA suppliers, inputs, processes, outputs, customers (SIPOC) diagram offers a high-level view of the 'as is' state of a process under investigation. The +C stands for constraints facing the system and the +M for the measures to be used.
Job Aid: How to Create a SIPOC Diagram (PDF) Use this job aid when you conduct team sessions to develop a suppliers, inputs, process, outputs, customers (SIPOC) diagram.
SMART matrixA SMART (specific, measurable, attainable, resources, time) matrix is a communication and planning tool used to identify the specifics of actions or tasks.
Success and effect diagram: Quality improvement Is not just for problemsUnderstanding successful processes can give you insight on how to improve other processes and continually improve efficiency and effectiveness—this tool can help you analyze successful processes and is a hybrid of the popular cause and effect diagram.