Businesses that operate a comprehensive QMS have a Representative that interacts with Customers and Employees to support the quality program. Here’s how a Company can create a subject matter expert to facilitate a new or upgrade QMS.
Reading Time: 7 minutes – Updated November 2025 to keep up or fall behind
Summary for How to Create a Subject Matter Expert:
Two documents assiduously enable a QMS subject matter expert:
- Quality Handbook
- 1st Half Completed Assessment Checklist
The quality handbook summarizes Company policies – what to do. The assessment checklist connects Customer flowdown requirements to QMS documents by names and paragraph numbers.
These two documents are the foundation for the volunteer that must endure the learning curve to become the subject matter expert.
10 Part Discussion:
Businesses that operate without a documented QMS perceive an overwhelming challenge when a new or existing Customer flowdown imposes QMS requirements. The outcries normally include, “We’ve got to do what?!” followed by, “We never had to do this before!”.
Risk-oriented Buyers do their best to screen Suppliers before making a decision to purchase goods or services. Large companies have well defined quality requirements for Suppliers. The goal for most Buyers is to reduce the risk of working with Suppliers that may cause problems with schedule driven projects. Buyers appreciate Suppliers that have a quality program and can assert compliance with ISO 9001, or have a pedigree. The logic is, if the paperwork is right then the product is right, because the Company has a quality program.
Of course, there are no guarantees that a compliant or pedigree-Supplier will perform according to expectations. The work to achieve compliance with technical and delivery requirements is the easy part for most businesses. The hard part is creating a subject matter expert, especially when a Company has never had to document practices.
Part 1: Volunteer Subject Matter Expert
The Company will volunteer someone to become the subject matter expert for the Customer flowdown. In most cases, the volunteer is a Responsible Authority that knows the business. The volunteer usually remarks: “We’ve got to do what?!”. And so it goes…
Part 2: The Romance Phase
The romance-phase of a business relationship is when a Company expends resources to convince Customers to buy products or services. For instance, a business needs to win a contract with a new Customer but doesn’t have a QMS. The Company knows the Customer wants the product or service but there’s a requirement for a management system in the proposal. Now-a-days, the flowdown requirement for a QMS is ISO 9001 or AS9003 Inspection and Test – among others – see How to Create a Quality Control Plan.
Part 3: No Matter What, the Subject Matter Expert…
Small businesses have learned to accept ISO 9001 and routinely create a subject matter expert to achieve QMS compliance or certification. One, two or three person businesses consistently demonstrate they can achieve compliance with an industry standard in a little more than eight (8) weeks. Creating a subject matter expert is a one-time effort regardless of how many Employees.
The volunteer helps people accept the challenges with enthusiasm rather than skepticism. Its particularly helpful when volunteers have a mentor or facilitator to create a subject matter expert.
No matter what, somebody in the Company must become the subject matter expert to represent the QMS with Employees and Customers. The learning curve is so much less complex when the volunteer starts the project with documentation that complies with Customer requirements.
Part 4: Initial Review and Redline
The quality handbook is a compilation of policies that describe “what” the Company will do. Quality procedures in the kit describe “how” the Company will apply policies. The soon-to-be subject matter expert needs to read the handbook to discover new requirements and vocabulary. After the initial review of the handbook, the volunteer determines exclusions. In a short time, the volunteer will talk-the-talk and walk-the-walk to facilitate changes.
Responsible Authorities are delegated to redline the quality handbook, then redline referenced procedures and forms. The goal is to tailor documents to fit the business and confirm exclusions. The volunteer is achieving small victories from each redlined document. Each released document achieves another step towards compliance. Celebrate and share each victory with participants in the project, and keep management up-to-date with progress.
Part 5: What You Find When You Start Looking
Its Ok to add and/or remove content in procedures and forms. The assessment checklist is the referee to confirm deletions and alterations do not impair compliance with the Customer flowdown. When the improvement team is confident the “paperwork is right”, the new documented information is ready for application in the business operation. The release of docs helps to finalize the QMS and take the emerging subject matter expert to another level.
Of course, its amazing what you find when you start looking in practically any business process. Discoveries cause every project to take on a life of its own. Welcome unexpected discoveries because they are the foundation for opportunities that add momentum to the project. Normally, business owners and managers find great solace in the fact that the Company is improving. Taking a look at every process that affects deliverable items and services is actually welcome. The result is continuous improvement that normally reduces costs and increases profits. As a result, the Company has increased confidence in the emerging subject matter expert.
Part 6: Records Demonstrate Conformity
Most companies know the work activities that need attention. This knowledge creates a natural list of priorities to pay particular attention during the discovery phase of the project. Processes that need attention are really good sources for small victories.
Create records using new and updated forms to enable additional discoveries that help to finalize the draft QMS. Each completed record is an opportunity for celebration. The goal is to produce records that enable the Company to assert compliance with the Customer flowdown. Use the effort for creating records to observe work operations in progress, then make appropriate adjustments to applicable procedures.
Part 7: Review and Redline of Work Activities
Responsible Authorities document existing work instructions and/or produce new work instructions. The “keep it simple” (KISS) Principle suggests work operations are best when they are as simple as possible.
Process maps are simple methods to describe work activities, which can:
- Include specification limits
- Refer to a training video or media
- Reduce details to the critical-few to avoid excessive text that Users might misinterpret
Apply the same effort for every work activity in the business operation that affects deliverable items. The implementation phase of the project will result in a finalized quality handbook, QMS procedures, work instructions, and forms. Another Company benefit is more confidence in the emerging subject matter expert.
Part 8: Documented Information
Archive redlines to demonstrate continuous improvement. Consider summarizing final release documents in a master list of configuration-controlled documents. The list provides a point of reference to establish the start of the compliance phase of the project. The ability of the subject matter expert to represent the Company’s QMS with the Customer is nearing conclusion.
Part 9: Pre-Assessment Audit Validates Assertion of Conformity
The last part of the improvement project is to document evidence of compliance in the quality system assessment checklist. The goal is to list records and testimony in the checklist to demonstrate compliance with requirements. Observations and findings discovered during the assessment may require another revision of QMS documents.
Configuration controlled changes to procedures become auditable records to further demonstrate compliance with the Customer flowdown. When the actions are closed from the initial assessment checklist, the Company can assert compliance with its QMS. This assertion should close the romance phase to enable a partner phase in the business relationship.
Part 10: Conclusion of the Learning Curve for the Subject Matter Expert
The Company now has a fully qualified subject matter expert that can represent the QMS with Customers. Continuous improvement is routine for product realization and QMS policies, procedures and forms.
The outcry expressed at the beginning of the initiative is usually replaced with:
- That wasn’t so bad
- That did us a world of good
How to create a subject matter expert is a component of how to create a quality control plan.
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