Manufacturing and service businesses need to learn how to create a quality control plan subject matter expert to represent the Company’s quality system with Customers, Registrar and Employees.
Businesses that have been operating for many years without a documented management system perceive an overwhelming challenge when a new or existing Customer imposes requirements for creating a quality control plan subject matter expert to implement and maintain a documented quality system such as ISO 9001. The outcries normally include, “We’ve got to do what?!” followed by, “We never had to do this before!”.
21st century Buyers are risk oriented and do their best to screen Suppliers before making a decision to purchase goods or services. Large companies like GE and Boeing have well defined quality control program requirements for Suppliers. The goal for most Buyers is to reduce the risk of working with Suppliers that may not perform up to expectations and avoid problems with schedule driven projects. The idea is, if the Supplier doesn’t have a quality control plan subject matter expert in place, the risk for problems is high if the paperwork isn’t right, which presumes the product or service isn’t right. On the other hand, 21st century Buyers appreciate Suppliers that can assert compliance with ISO 9001 or have a pedigree for a more comprehensive quality plan, such as the AS9003 Inspection and Test quality system or AS9110 Quality System or AS9120 Quality System or Nadcap Quality System Plan or FAA PMA quality system. The logic is, if the paperwork is right then the product or service is right because the Company has a quality control plan subject matter expert.
Of course, there are no guarantees that a compliant or pedigree Supplier will perform according to expectations. In practice, risk management concerns are reduced when a Supplier’s quality control plan is compliant with an industry standard such as ISO 9001 and the Quality Representative is a subject matter expert. The work to achieve compliance with technical and delivery requirements is the easy part for most businesses. The hard part is creating a quality control plan subject matter expert to achieve compliance with quality system requirements, especially when a Company has never had to document practices. What this means for a business is someone in the Company is going to be volunteered to become the new quality control plan subject matter expert. In most cases, the volunteer is a responsible authority that knows the quality improvement project will result in more sales. More income is the carrot at the end of the stick or pot of gold at the end of the rainbow. The analogy of “rainbow” is appropriate for a new quality improvement project because there are usually thoughts of multi-color bruising of the status-quo because of the outcry, “We’ve got to do what?!”. It can be disappointing when a Company doesn’t have a quality control plan subject matter expert!
The work that a Company expends to convince Customers to buy products or services is known as the romance-phase of the business relationship. For instance, a business needs to win a contract from a new Customer but doesn’t have a quality control plan subject matter expert to document a quality system. Let’s presume the Customer wants the product or service but there’s a new requirement for a quality management system in the proposal. Now-a-days, the flowdown requirement for a quality control system is ISO 9001 or a tailored ISO 9001 quality system. Normally, when ISO is mentioned during the romance-phase, the wheels fall off the expectation of winning a contract because ISO is perceived as “too much work”. The knee-jerk reaction is to take this job and shove it. In reality, if small victories are won during the implementation phase of an ISO 9001 quality improvement project, even the most doubtful manager or business owner can see light at the end of the tunnel. ISO 9001 is perceived as an overwhelming task but Ma and Pa shops have learned to accept the challenge and routinely create a quality control plan subject matter expert to achieve compliance and certification while starting their project from “There’s too much to do!” and ending with “That wasn’t so bad!”. One, two or three person businesses consistently demonstrate they can achieve compliance with ISO 9001 in a little more than eight (8) weeks. Of course, as the number of people increases in the Company, more time is needed to cover all the bases.
Its particularly helpful when newcomers to quality management have a mentor or facilitator to help the Company create a quality control plan subject matter expert to guide the process of improvement from beginning to end. Reducing the substantial list of action items to the critical few and implementing improvement opportunities helps people accept the challenges with enthusiasm rather than skepticism. No matter what, somebody in the Company must become the quality control plan subject matter expert to represent the quality system with Employees and Customers. The recommendation is to start the quality improvement project with documentation that complies with Customer requirements using an At-PQC™ kit.
The quality manual in the kit is a compilation of policies that describe “what” the Company will do and quality procedures in the kit describe “how” the Company will apply policies. The soon-to-be quality control plan subject matter expert needs to read the quality manual to discover new requirements and a new vocabulary. After the initial read, the “project volunteer” for quality control plan subject matter expert needs to study the quality manual to challenge boilerplate requirements to determine if some can be excluded, which is possible because ISO 9001 is designed to fit every business by declaring exclusions to requirements that are not germane to the Company. Exclusions cannot be applied out of desire, which is where the mentor or facilitator can help finalize the draft version of the quality manual. In a short time, the person responsible for becoming the quality control plan subject matter expert will talk-the-talk and walk-the-walk of ISO 9001.
After redlining the quality manual, the soon to be quality control plan subject matter expert needs to read quality management system (QMS) procedures that are referenced in the manual. Redline their boilerplate content to precisely fit the business operation and confirm exclusions with the mentor or facilitator. Redlining and releasing each draft document in the ISO 9001 quality system kit can be counted as small victories and 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. After redlining and releasing draft QMS procedures, read forms that are referenced in the quality manual and redline their boilerplate content. Its Ok to add content to procedures and forms but check with the mentor or facilitator to confirm deletions and alterations do not impair compliance with ISO 9001. When the improvement team is confident the “paperwork is right”, the quality improvement project is ready for application in the business operation, which will help to finalize Company policies, procedures and forms and take the emerging quality control plan subject matter expert to another level.
Of course, its amazing what you find when you start looking (at practically any business process) and that reality causes every project to take on a life of its own. Welcome unexpected discoveries because they are the foundation of opportunities that add momentum to the quality improvement project. Normally, business owners and managers find great solace in the fact that the Company is growing stronger because of the discoveries and corrections made during the implementation phase of the once overwhelming ordeal imposed by a Customer. Taking a look at every process in the business operation that affects deliverable products and services from an “Auditor’s” perspective is actually a welcome addition because the result is continuous improvement that reduces costs and increases profits.
Most companies know the business processes that need attention and that knowledge helps to create a natural list of priorities to pay particular attention during the implementation phase of the quality improvement project. Processes that need attention are good places to initially apply new Company policies, procedures and forms. The goal is to produce records to enable the Company to assert compliance with the ISO 9001 quality control system. Create records using the new forms to enable additional discoveries that will help to finalize draft QMS documents as a result of practical application. Each completed record using new forms is an opportunity for celebration and helps to finalize each form and drag the quality control plan subject matter expert closer to their goal.
Use the effort for creating records to observe work operations in progress and make appropriate adjustments to applicable product or service work instructions and QMS procedures. The goal is to confirm that existing work instructions are correctly documented or to create instructions if they don’t already exist. Sometimes, all that is needed to correctly document product or service work instructions is a flowchart or process map that contains or refers to applicable specifications or requirements. When using process maps for work instructions, a training video or other training media can be used to fill in details to avoid excessive text that can be misinterpreted by Users. The “keep it simple” (KISS) Principle suggests work operations work best when they are as simple as possible rather than made complex.
Apply the same effort for every work function in the business operation that affects deliverable product or service. In a short time, the Company can easily assert compliance with the ISO 9001 quality control system. The implementation phase of the quality improvement project will result in a finalized quality manual, QMS procedures, product or service work instructions, forms and more confidence in the emerging quality control plan subject matter expert. When all quality management system documents are redlined to describe actual business practices, formally release the documents and prepare a list to establish a baseline of configuration controlled Company policies. Repeat the process for training media, work instructions, product or service specifications and forms. The lists will provide a point of reference to begin the compliance phase of the quality improvement project and practically cement the education of your Company’s quality control plan subject matter expert.
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 answer questions about where the Company’s QMS documents and work instructions demonstrate compliance with requirements. Observations and findings discovered during the assessment may require revision of QMS documents. Configuration controlled changes to Company policies and procedures become the first records of continuous improvement to further demonstrate compliance with ISO 9001. When the assessment checklist is completed and applicable QMS documents are revised and formally released, the Company can assert compliance with ISO 9001 and share results with Customers to advance from the romance-phase to the partner-phase in the business relationship. The Company now has a quality control plan subject matter expert that can represent the quality system with Customers and facilitate continuous improvement and maintenance of policies, procedures, work instructions and forms. The outcry that the wheels are going to fall off due to the perception of overwhelming requirements of ISO 9001 are normally replaced by the perception of “That wasn’t so bad.” and “That did us a world of good!”.
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