Quality Assurance Plan – 5 Steps to Improve Production Quality

Manufacturers need to ensure that they provide quality products to their end customers. Not only does this increase customer satisfaction, but it also enhances a manufacturing company’s reputation in their respective industry.

A defined quality assurance plan helps manufacturers bring this goal to fruition. A quality assurance plan sets out the standards, resources, and practices that personnel across the organization should use to ensure that the final product ticks all boxes spanning customer satisfaction and regulatory compliance.

However, in some instances, manufacturers might find that industry standards might not satisfy their business objectives due to complex manufacturing processes. Therefore, such manufacturers – for example, in the automotive industry – develop an advanced quality plan (advanced product quality planning) to ensure that they meet their superior quality standards.

Read on to learn how a quality assurance plan can help you improve production quality across your operations.

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Consistent quality is a sought-after factor in the vast majority of manufacturing operations. And with the advent of Industry 4.0, more quality requirements have sprung forth, necessitating manufacturers to develop more comprehensive quality management systems. As such, quality assurance plans have come to the fore.

A quality assurance plan is a document that highlights the standards a given manufactured product should adhere to. Furthermore, this plan also contains the practices that need to be executed to ensure that the product meets the set requirements.

Additionally, the quality assurance plan also outlines personnel responsible and the resources that will go into the manufacturing process so that the product never falls short of the standards set. Also, this plan sets out the quality control measures necessary to ensure that the product meets specifications.

In doing all this, the plan covers all aspects of production quality before an end-product is shipped and delivered to the customer.

Although sometimes used interchangeably, quality assurance (QA) and quality control (QC) are quite distinct. However, both of these are features of the broader quality management system.

Quality assurance tends to be used more broadly and begins defining quality standards even before the manufacturing process kicks off. In other words, QA is integrated into the entire process to predict and prevent defective items from being produced.

On the other hand, quality control later identifies if any defective products have come off the line. As such, QC is seen as a last line of defense, ensuring that unsatisfactory and nonconforming products don’t make it into the customers’ hands.

A quality assurance plan provides several benefits to manufacturing businesses.

These include:

Improved production efficiency: A quality assurance plan details the production process to ensure that all necessary standards are met. This includes identifying and preventing possible bottlenecks that may hamper production.

Additionally, a QA plan assigns responsibility to various individuals at different stages of production the production process. This ensures that all personnel know their specific duties and how to execute them.

Lower production costs: Because a QA plan examines the manufacturing processes even before production begins, it identifies areas of potential failure that can significantly impact manufacturing costs.

This allows the relevant personnel to execute preventive actions, ensuring that the line operates optimally when production kicks off.

Gaining and maintaining customer trust: Customers expect only the best when they purchase products from a business. Therefore, manufacturers need to ensure that their production processes provide customers with goods that meet their needs and exceed their expectations.

That’s where a well-thought-out quality assurance plan comes in. The program points out standards that products must adhere to before being put in the hands of customers. Consequently, manufacturers gain trust and repeat business from customers satisfied with their purchases.

Better work environment for employees: Quality assurance plans include employees in assessing the totality of a manufacturing operation. After all, operators are the ones actually doing the work and have direct input into the production processes.

As such, a QA plan insists on workers operating in ideal work conditions. The plan identifies potential work hazards and recommends relevant solutions. Consequently, satisfied employees are more motivated to execute their tasks, driving other quality assurance goals like efficient production and lower costs.

Compliance with regulations and standards: Manufacturers need to conform to various standards and regulations to compete favorably in the market. As discussed earlier, quality assurance plans allow businesses to comply with workplace and product safety regulations.

Furthermore, QA plans can outline industry standards governing the quality of raw materials used in product manufacturing. Using raw materials that meet these standards and specifications can be imperative for the business, allowing it to pass regulatory audits.

A QA plan is the rulebook for how you keep things under control. When it’s written with care, people know what to do, what to check, and who’s responsible when something goes wrong. Whether you’re trying to meet ISO 9001 or just tired of the same quality issues showing up, the structure of the plan makes a difference.

Quality Objectives
Start with clear goals. Maybe you’re trying to cut scrap, improve first-pass yield, or get better traceability. Whatever it is, make sure it’s measurable and tied to what actually matters in your process. A plan without targets turns into a filing exercise.

Roles and Responsibilities
Lay out who does what. List who writes inspection procedures, who signs off on them, who handles nonconformances, and who closes actions. When these things aren’t clear, problems bounce between departments and nothing gets fixed.

SOPs and Documentation
This is the working side of the plan. Reference your SOPs, inspection methods, and forms. Say where they’re stored, how often they’re reviewed, and who owns them. If you use digital systems, point to those instead of attaching outdated copies.

Quality Metrics and Data
Pick a few key numbers and track them consistently, some of them are defect rate, FPY, cost of quality, whatever fits your process. Be specific about how data is collected and who reviews it. If no one looks at the numbers, you’re not managing quality in fact you’re just recording failures.

Inspections and Audits
Spell out when checks happen and what gets inspected. Cover incoming material, in-process checks, final inspection, and internal audits. Write down how issues are logged and how quickly they need attention. Gaps here usually show up later as rework.

Deviation Handling and CAPA
When parts go off spec, document it. Define how a deviation is reported, who investigates, and how corrective actions are verified. The objective is to keep the same issue from coming back.

Continuous Improvement
Plans get stale if you don’t revisit them. Set regular reviews i.e. quarterly or annual to look at data trends, audit findings, and customer complaints. Use that time to update procedures and tighten weak spots.

If you’re starting from zero or fixing a binder that no one’s opened in years, this walkthrough will help you build a QA plan people actually use. It connects directly to production, gives structure to daily work, and helps you see where quality stands in real time.

Step 1: Define Quality Goals That Matter
Begin with the outcomes you want. Are you trying to cut scrap, stabilize yield, or meet a new regulatory standard? Pick two or three measurable goals that line up with how your operation runs.
Examples: reduce rework by 20%, reach 95% first-pass yield, or pass the ISO 9001 audit by the next quarter. These targets will shape everything that follows.

Step 2: Map the Production Flow
Lay out each step from raw material to finished part. Mark where handoffs happen, where people make decisions, and where errors are most likely. You’re not writing a textbook, just capturing the points where quality can drift. That’s where inspections, data checks, and documentation need to live.

Step 3: Assign Ownership
Good plans fail when no one owns the work. Be clear about who handles inspections, updates procedures, manages training, and closes CAPAs. Write names, not departments. Accountability is what keeps the plan alive after rollout.

Step 4: Document Procedures and Standards
Collect your SOPs, inspection instructions, and quality criteria in one place. They should match how the work is actually done, not how it’s supposed to be done. If you’re still running on paper, link procedures to the workstations digitally so operators always have the current version. That alone can prevent half the recurring errors.

Step 5: Choose Metrics and Data Sources
Decide what you’ll measure and how often. A few good metrics beat a long list that no one reviews. Track things like defect rate, first-pass yield, and cost of quality. Be specific about where the numbers come from i.e. manual log, sensor data, or digital entry and who reviews them. Data without ownership just piles up.

Step 6: Define How You Handle Problems
When something goes off-spec, what happens next? Write the flow: how the issue is logged, who investigates, and how corrective actions are verified. In digital systems, build CAPA workflows directly into your quality dashboards so the response doesn’t depend on memory or email threads.

Step 7: Review and Adjust Regularly
Set a schedule to review the plan, it can be quarterly or after each major audit. Look at your data trends, repeat issues, and what’s changed in production. Update procedures and retrain as needed. A QA plan only works if it keeps pace with how the plant actually runs.

A QA plan is only as good as the numbers you use to run it. The right metrics show whether processes are stable, where waste is creeping in, and when to act before problems grow. But tracking everything isn’t the answer. A few well-chosen KPIs, tied to daily operations, tell you far more than a crowded dashboard ever will.

First Pass Yield (FPY)
This is the share of parts that clear inspection the first time, without rework.
When FPY drops, something in the process has shifted i.e. material, setup, training, or maintenance. Tracking it by product, line, or shift helps you see where to dig first.

Cost of Quality (COQ)
COQ combines two sides of the same coin: what you spend to ensure quality, and what it costs when quality fails.
It’s broken into prevention, appraisal, internal failure, and external failure. Once you see how those costs stack up, it’s easier to decide where to invest, e.g. training, automation, or better inspection coverage.

Defect Rate
A simple measure: defective parts divided by total output over a defined time or batch.
Watch it by operator, material lot, or machine. When rates rise above limits, you’ve got an early signal to stop and investigate before the next run repeats the problem.

Audit Pass Rate
Shows how consistently your systems meet defined standards, whether internal checks or third-party audits.
It’s especially useful in regulated environments, but it also highlights whether people are actually following approved procedures on the floor.

Time to Resolution (Deviations and CAPAs)
Measures how long it takes to close a nonconformance or finish a corrective action.
Fast closure usually means clear ownership and effective workflows. Long delays suggest bottlenecks or weak follow-up.

Practical tip: pick no more than five metrics that connect directly to your quality goals. Make them visible at the point of work, not buried in reports. When the data is current and accessible, it stops being a report and starts driving action.

Managing Deviations, CAPA, and Continuous Improvement

No QA plan prevents every problem. That’s not realistic. What matters is how your team reacts, how quickly issues get contained, and whether the fix actually sticks.

Handling Deviations at the Source
When a part, process, or result drifts from spec, people need to know exactly what to do. Start by defining what qualifies as a deviation, how it’s reported, and who reviews it.

Many plants use a Material Review Board (MRB) to sort and decide what happens next—whether to rework, scrap, or accept under concession. The key is consistency. If operators aren’t sure when to flag an issue, you’ll find out later, usually in rework or a customer return.

Capturing deviations digitally, right at the station, keeps the record clean and saves time later during audits or investigations.

Root Cause and CAPA
Once a deviation is logged, the next step is understanding why it happened and what to do about it. That’s the role of CAPA: Corrective and Preventive Action.

• Corrective: fix the immediate cause.

• Preventive: fix what allowed it to happen in the first place.

Your QA plan should outline when to open a CAPA, who’s responsible, and how completion is verified. High-risk or repeat issues always qualify. The rest can often be handled through local containment and short-term fixes, but they still need to be tracked.

Continuous Improvement and Review
Deviations and CAPAs only add value if you learn from them. Set a review schedule, it can be monthly, quarterly, or tied to audits, to look for trends.
Are the same suppliers showing up in MRB meetings? Are certain shifts seeing more rework? Are training gaps obvious?

The patterns you find here guide the next round of improvements, from updating SOPs to tightening supplier checks. Over time, this loop—deviation, investigation, correction and review becomes part of how production runs, not an extra task.

When this workflow lives inside your digital system where operators log deviations, engineers investigate, and managers review—you get one connected record of quality activity. That’s what turns QA from reaction to control.

For a lot of manufacturers, quality lives in binders.

You’ve got printed SOPs, paper checklists, and spreadsheets saved somewhere on a shared drive. It technically works, but only just. Updates are slow, data gets lost, and the people doing the work rarely have the latest information in front of them.

Digital QA plans flip that model on its head.

Instead of tacking quality on at the end, a digital plan makes it part of the work itself. Instructions show up at the station, inspections are built into the process, and issues get flagged in real time, before they become rework.

Here’s how the two approaches stack up:

A digital QA plan isn’t just a tech upgrade. It’s a shift in how quality work happens. Operators see exactly what’s needed. Engineers get clean data. Managers know what’s working and what’s not, without digging through reports.

That’s the difference between reacting to problems and staying ahead of them.

QA plans shouldn’t look the same across every industry. The risks, regulations, and pace of change aren’t identical. A plan that works on a drug line won’t fit a metal stamping cell. What matters is matching the level of control and documentation to the environment you’re in.

Regulated Manufacturing
In pharma, medical devices, food, or aerospace, every action has to be documented. Not summarized documented. You need a clear trail of what happened, when, and who signed off.

Your plan should cover:

• Full traceability of materials and process steps

• Controlled records with version history and e-signatures

• Defined CAPA and complaint handling

• Rules for validation and change control
  
  

Most teams follow FDA 21 CFR Part 820, ISO 13485, GMP, or ICH Q10. These aren’t boxes to check, they shape how you run quality day to day. Digital systems help by handling traceability and record keeping automatically, so the team can focus on the work instead of chasing paperwork.

Discrete Manufacturing
Automotive, electronics, and industrial plants run fast. Stopping the line for inspection isn’t always an option. The QA plan has to keep up with production speed while keeping the data reliable.

Focus on:

• In-line checks that fit cycle times

• Quick containment when problems show up

• Standard methods across multiple lines or plants

• Compliance with IATF 16949 and ISO 9001:2015

Here, digital QA tools cut the lag between finding an issue and fixing it. A change to a checklist or inspection can roll out across stations in minutes. That keeps everyone on the same page without slowing the line.

Each industry drives a different balance between control and flexibility. The goal is the one that fits your work, meets your standards, and can adapt without starting over.

Manufacturers should consider the following steps to improve production quality.

Consider the customers’ needs: Quality assurance aims to prevent defects and other problems from cropping up in the production process. One way to ensure that the final product ticks all boxes is to incorporate the customer’s needs in the planning process.

With this in mind, manufacturers can design processes that ensure the customer gets exactly what they need.

Vet suppliers thoroughly: Even with top-notch production processes, a manufacturing business can struggle if it utilizes poor-quality raw materials.

As such, manufacturers need to extend their quality assurance plan to cover suppliers as well. It pays to conduct due diligence before taking on a supplier to ensure that they, too, comply with standards and regulations connected to the materials.

Develop a quality-centered culture: Because quality doesn’t start and end with the quality management department, it’s prudent for manufacturing businesses to involve all personnel in quality assurance efforts.

Therefore, top management should consult all departments to understand better how different areas can impact quality across the operations.

Continuous worker skill development: As quality standards evolve due to the constantly changing business environment, so do the skill requirements needed.

Consequently, manufacturers need to continuously upskill their employees so that the operation doesn’t lag when it comes to offering quality products.

Leveraging Quality 4.0: As the manufacturing landscape has changed due to Industry 4.0, so has the level of quality management required. Industries like automotive manufacturing have embraced smart factories, with many crafting an advanced quality plan to take advantage of Quality 4.0.

Connected devices collect data that is subjected to modern analytics to provide more comprehensive insights into quality management across the production cycle.

If you're interested in learning how Tulip can help improve your quality management practices, reach out to a member of our team today!

A QA plan only works if people can use it and keep it current. That’s where Tulip helps. It turns what used to live in binders and shared drives into live instructions, checks, and records right at the workstation.

Whether you’re setting up a new quality system or trying to modernize an existing one, Tulip gives teams a way to build and adjust their plan without waiting on IT.

Build Apps That Bring the Plan to Life
Teams can use Tulip’s no-code tools to create apps that walk operators through approved steps, record inspection data, and collect sign-offs. Deviations get flagged automatically. Updates take minutes instead of days, which makes it easier to keep SOPs aligned with how the work is really done.

Capture and Use Data in Real Time
All the usual metrics like first-pass yield, defect rate and CAPA status can be collected as part of the job. No extra forms or spreadsheets. Dashboards show what’s happening now, not last week, so supervisors can spot trends and act sooner.

Close the Loop on CAPA and Improvement
When a deviation is logged, workflows can route it to the right person, track the investigation, and verify the fix. Everything stays documented and searchable. It’s one system for finding issues, fixing them, and learning from them.

Stay Adaptable
Tulip isn’t an all-or-nothing system. You can start small with a single inspection app or line and expand as needed. Each module plugs into the next without rebuilding from scratch. That flexibility makes it useful for both regulated and high-volume environments.

If you want to see how this looks in practice, check out the Tulip Quality App Suite or walk through a short demo. It’s the simplest way to see how a digital QA plan actually runs on the floor.

Connected devices collect data that is subjected to modern analytics to provide more comprehensive insights into quality management across the production cycle.

If you're interested in learning how Tulip can help improve your quality management practices, reach out to a member of our team today!

A QA plan isn’t just a compliance file. It’s how you keep work consistent, control risk, and spot problems early. When it’s built around real production data and kept current, it turns into part of how the shop runs every day and not an extra layer of paperwork.

Digital systems make this easier. They connect the plan to what’s happening on the floor, track metrics automatically, and close the gap between finding an issue and fixing it.

The goal is simple: a quality system that moves with your operation. One that scales, adapts, and helps you meet standards without slowing down the work that keeps the plant running.