Introduction
“Improving the work is the work.”
An effective quality management system (QMS) is an important piece of creating a sustainable, successful business. A quality management system is a formalized system that documents processes, procedures, and responsibilities for achieving objectives. Collectively, the system is intended to meet consumer demands, regulatory requirements, and instill a process of continuous improvement.
NATM has long recommended its trailer manufacturing members have a quality management system in place, and as such, the Association has created the following guidance to help member companies establish or improve an existing program.
It is important to note that the following is simply a generalized recommendation and each quality management system should be specific to the company for which it is created.
Why a Quality Management System?
A quality management system provides numerous benefits to a company, including but not limited to;
· Process Repeatability
· Warranty Reduction
· Waste Reduction
· Reducing Mistakes
· Lowered Costs
· Identification of Training Opportunities
· Increased Staff Engagement
· Improved Organizational Direction and Clarity of Purpose
· Continuous Improvement
· Reduction in Order Cycle Times
· Improved Customer Satisfaction
· Competitive Advantage
· Improved Manufacturing Efficiencies
Step One: Identify Objectives/Goals
The first step to creating a QMS is to identify the objectives and goals of the system. These objectives and goals may change over time, but identifying what the system is preliminarily intended to accomplish will help guide the team of people tasked with creating the system and provide a basis for measuring the outcomes of the system in the future.
While objectives/goals will vary by company, there are a number of objectives that are true for most, if not all, systems.
Continuous Improvement
Finding Efficiencies
Improve Processes
Consistent Output
Cut Costs
Reduce Risk
Comply with Regulations
Other objectives might include market share, employee satisfaction, financial performance, safety or safer work environment and more.
Step Two: Define Core Processes
Defining the core processes of your business, and beginning to document those processes is the next step. This is a high-level map of the work the company undertakes and the interaction of these processes. At this stage, each process should have a defined owner.
In a trailer manufacturing setting core processes might include purchasing, HR, production, warranty, and beyond.
Step Three: Identify Key Stakeholders and Leadership
This is a critical step in creating a functional QMS. Identifying key stakeholders and then drawing in these parties through the creation process and the carrying out of the QMS is what will make or break the QMS. Without this buy-in, the system will not be effective and has a high likelihood of falling apart completely.
This group should include process owners and select members of your team. This team needs to be diverse, covering the different departments within the organization as well as the various levels of your organization. Diversity in a trailer manufacturing setting would include individuals from senior-management to entry-level roles and from various departments such as parts, production, purchasing, welding, assembly, and coatings/paint.
In terms of defining leadership, some organizations identify a singular Quality Manager or Director responsible for the overall implementation and monitoring of the QMS. In other organizations, it may be a team of people with varying levels of responsibility working in concert. There is no right answer for any one organization, the key is diversity of participation and stakeholder buy-in.
Step Four: Create Documentation
Documenting processes and procedures may be the most intensive time investment in the creation of the QMS. This includes policies, procedures, work instructions, checklists and an overarching Quality Policy Manual that links all of these documents together at a high level.
Policies
It may be easiest to begin with policies as most organizational policies may already be written down. This would include policies on warranty claims, HR, and beyond. Policies should be written by management/executive-level employees. They should also be communicated to employees, and where applicable, readily available to employees to review. Access to documentation is covered below under Step Five – Document Control.
Operating Procedures
Next, operating procedures. These are outlines of process flows, including who does what and when. These will reference other documentation like work instructions, forms, checklists, and the like. The purpose of operating procedures is to define how various projects and programs are carried out. It is also possible that one operating procedure references another – acknowledging the interplay is an important function of these documents. The document should reference forms, work instructions, and other documentation involved in the process. It should also include how duties are deputized in the absence of named employees so there is a clear instruction as to who shall take over certain processes. Operating procedures should be written by the owner of the process with input from subordinate staff who are involved in the process being described.
A template operating procedure template can be found below. The template includes a sponsor – the person writing the procedure and the name of who approved the document. This may or may not be necessary, but is a good system of creating checks and balances for the creation and editing of operating procedures.
A sample Document Control Procedure, explained later in this document, can be found below.
As a reminder, operating procedures are intended only to give an overview of the process and link to various other helpful resources and documents, but are not the detailed step-by-step of the actual work – that is left to work instructions. Operating procedures in a trailer manufacturing setting might include the production process, purchasing and procurement, complaints and warranty claims, record retention practices, and more.
If the production process at a high level is the same for each type of unit sold, one procedure may be sufficient. For substantially different units where production follows differing processes, more than one procedure may be appropriate.
Work Instructions
Work instructions are a detailed, step-by-step, of how to carry out a task from start to finish. (In many manufacturing settings these are also called Standard Operations Procedures or SOPs.)
Work instructions are going to tell the reader exactly how to do a job. The intention is that an individual who may be new to the task should be able to read through the instructions, follow them closely, and carry out a task about which they know little to nothing. Work instructions are incredibly helpful for onboarding, for non-routine tasks, and can be instrumental in positions with high turnover. These documents should be written for as many tasks as possible and are key to creating consistency in production. Work instructions might include placement of stickers on the unit, flooring installation, and torquing amongst much more.
Work instructions should include photos or drawings when helpful. The work instruction should include a purpose, any necessary background information as needed, and the individual(s) responsible for the accuracy of the work instruction along with the step-by-step details. Work instructions should be numerous. Every task should have accompanying instruction. As a frame of reference, NATM has more than ten times the number of work instructions than it does operating procedures.
Forms
Creating forms, to include checklists, reports, and the like, to ensure standardization and proper information collection is a key function of the documentation process. These forms and material should be referenced in operating procedures and work instructions for clarity and correctness.
Examples of these might include quality checklists, warranty claim forms, vacation request forms, and more. For trailer manufacturers, the use of a quality checklist for reviewing units at designated points throughout the manufacturing process is often the most effective mechanism for supporting consistent, quality outcomes. Sample checklists can be found below.
Quality Policy Manual
Documentation is incomplete without a Quality Policy Manual. This is the overarching guide to the Quality Management System. However, the Quality Policy Manual creation will be the very last step in the creation process of your quality system and will be touched on again later in this guidance.
Step Five: Creating Necessary Processes
Quality management systems are not complete without defined, documented processes that ensure appropriate access to information, opportunities for feedback, and regular reviews of the system to ensure its adequacy. The following are hallmark features of QMS systems;
At a minimum, the Document Control Procedure should cover the following;
Identify how and by who documents are approved for adequacy prior to use – the who may vary across document types for example leadership over purchasing would not likely approve documents related to production.
A system for regularly reviewing and updating documents to ensure continued adequacy – at a minimum annual review is recommended.
Ensure that changes are tracked and the current revision status of the documents is clear
- Most often changes can be tracked on internal documents directly in the document through the Change Log – chart below. For some documents, including those for external circulation, tracking changes likely would not be included on the document in a change log, but listed elsewhere for reference.
* For NATM these references are kept in our Master Document Control list which also includes hyperlinks for document accessibility and other related information.
* A brief glimpse of this document can be found below.
* Change log
Documents are available to those who would need access which also includes identifying any limitations to access where applicable
Documents are legible and identifiable
- Identifiable generally references a document naming system – each document will have a document number (which can include letters as well). The template document control procedure includes a sample system for document numbering.
Prevention of unintended use of obsolete documents
A copy of the NATM Document Control Procedure can be found below. This is certainly not the only methodology for controlling documents, but may be a helpful tool in developing a plan that is best situated to a company’s own unique needs. For companies that use significant printed materials, whereas NATM limits most items to server access, a robust process for ensuring those printed materials meet the above-mentioned requirements will be needed.
Records Control
Trailer manufacturers are creating a number of records, both as mandated by federal law (i.e. tire recordkeeping) and as part of their own control systems. As such, it is important to develop a procedure for controlling records.
At a minimum, a Records Control Procedure should cover the following;
Ensure that records are identifiable
Where and how records are to be stored – this includes both digital and physical copies
How records should be protected
How long records are to be retained
How records are to be disposed of when disposal is required
NATM would recommend working with legal counsel directly in the creation of a records retentions schedule to ensure your business is both keeping adequate records and disposing of records that should no longer be retained. This schedule is often governed by local, state, and federal regulation.
Corrective and Preventive Action
A successful QMS is dependent upon continuous improvement. Through the creation and implementation of a Corrective and Preventive Action Procedure a company is both taking in feedback about existing issues (often called nonconformities in quality language) as well as actively thinking ahead to what could become an issue and correcting course before it comes to fruition.
At a minimum a Corrective and Preventive Action Procedure should cover;
How issues are identified
Determining the cause
Correcting the issue
Determining what, if any, action is needed to prevent reoccurrence
Recording the result of actions taken
Follow-up at a future date to ensure corrective action was appropriate and effective
How Issues are Identified
This section of the Corrective and Preventive Action Procedure should outline and if necessary, create, feedback loops within the organization – both internal and external sources. This might include management meetings, team/department meetings, company-wide meetings, but also opportunities for individuals from your staff to submit nonconformities – perhaps anonymously – for correction or prevention. This also includes customers and other third parties. Tracking complaints and warranty claims can highlight trends that may need corrective action. Thinking through the various groups that are invested in the finished product will help companies to determine the various feedback loops that should be incorporated into the procedure.
Determining the Cause
There are a number of ways to undergo a root cause analysis. Perhaps the easiest is the “5 Whys” – asking why the nonconformity exists, and then why the answer to the first why is the case, and continuing down the path until the root cause is identified.
For example, “why is weld quality poor?” The first answer might be “Employee X did a poor job” and the next why asks “why did Employee X do a poor job?”, the answer might be “he didn’t know what the weld quality expectations were,” to which again the question is asked why eventually perhaps leading to the company doesn’t have a proper onboarding process the ensures the welders are educated and fully capable of meeting standards.
A nonconformity cannot be fixed until the root cause is determined and then addressed. While generally asking “Why?” 5 times is sufficient, not every issue will require exactly 5 whys.
Correcting the Issue
After the root cause is identified, the next step is to correct the issue. Sometimes the fix is simple and other types, the fix may take time and multiple steps.
Determining What, If Any Action, is Needed to Prevent Reoccurrence
Correcting the issue alone is not always enough. For each nonconformity, it needs to be determined if there is a risk of reoccurrence and what action should be taken if there is a risk. The goals of the corrective and preventive action procedure are quite simply, to improve processes and limit mistakes and most especially the reoccurrence of mistakes.
Recording the Results of Actions Taken
Recording the corrective and preventive action taken is a key step. Documentation of a nonconformity or a predicted nonconformity, its root cause analysis, and the actions taken to correct or prevent the nonconformity are foundational for many pieces of the quality management system. In the next step, documentation will be key. But later, this guidance will discuss an internal audit and annual management review, both of which will look at corrective and preventive actions over the course of the last year and even previous years to determine patterns and the need for additional action.
It is necessary to a have a form for taking down the information about the nonconformity and recording the resulting sequence of events to ensure all required steps are taken. A sample of a corrective and preventive action form can be found below.
Regular Reviews and Audits
The documentation and implementation of processes and procedures is important, but a coordinated procedure for reviewing and auditing adherence to these systems is key for success.
Review
Reviewing the quality system is an ongoing process. While an annual audit is a key function of ensuring the effectiveness of the program and compliance with its tenants, regular reviews throughout the year are important to ensure barriers to success and even patterns in feedback loops or corrective actions are dealt with more swiftly.
A quality team should be selected and a regular meeting schedule selected – monthly is recommended – to review various aspects of the system. A typical agenda might include;
Corrective and Preventive Actions
Complaints
Customer Satisfaction
Training
Recommendations for Improvement and New Initiatives
The quality team should include a broad cross-section of departments and/or processes. Typically, the team is comprised of individuals from the leadership as many decisions are made and actions result from these meetings. For larger companies, it may be helpful to create departmental quality teams that meet monthly and then cross-departmental teams that meet bi-monthly or quarterly.
Audit
Every organization and each process and procedure may require audits at different intervals – perhaps key processes and procedures should be audited several times throughout the year. At a minimum, the entire Quality Management System should be audited once per year.
Some organizations choose to undergo the entire audit at one point in time – typically scheduled for the least busy time of year. Other organizations review and audit processes and procedures on a rolling basis all year long. It makes no difference which system is chosen, only that each process and procedure is reviewed at a minimum annually.
Further, selecting an auditor or audit team is key. Individuals who conduct the audit should be knowledgeable in audit processes and the procedures they are auditing, but should not be participants in the process to ensure the audit it completed without bias. Further, the auditor needs to be given the authority to undertake the audit and supported by top management in the process.
At a minimum an Audit Procedure should;
Outline when and by whom each process and procedure is to be audited
Outline auditor training requirements – typically scaled based on experience
Reference any supporting materials – typically template audit forms are created to ensure the audit covers the entire procedure and process and all sample sizes are statistically valid
Define what the audit report will contain
Define the process for correcting any nonconformances found throughout the audit
- Typically, nonconformances are categorized by their severity in the report structure.
- These categorizations should then dictate the necessary corrective action. Less significant nonconformances might require a simple fix with little involvement from outside parties.
Layout the structure of the closing meeting – who is involved, what information is provided, how soon after the close of the audit should the closing meeting occur.
Please note, following the audit it is vital that those individuals responsible for the process or procedure being audited are notified of the results of the audit and any resulting actions taken or to be taken. Quality management systems require complete buy-in from top to bottom and providing relevant outcomes is key to ensuring that buy-in exists.
Reviews and audits are helpful both to ensuring processes and procedures are being implemented correctly, but are also an opportunity to refine a process and procedure. Often, when a nonconformance is identified through a review or audit process, the underlying cause is related to the need to adjust the process and procedure. Audits are not for catching wrong-doers, but in ensuring complete understanding of responsibilities and expectations and improving systems.
Annual Management Review
Quality Management Systems are only effective when the entire team is committed to the process. This includes top management. On an annual basis top management should be meeting to review the Quality Management System to ensure it is appropriate to the needs of the company and is meeting the stated objectives for its creation.
An annual management review should cover a number of topics including, but not limited to;
Audit results
Feedback from customers, clients, staff, and other interested third parties
Status of corrective and preventive actions
Any follow-up actions from the last management review
Results of needs assessments
- Before a management review, staff should complete a needs assessment survey.
* This is an opportunity to create another feedback loop within the organization.
* The needs assessment allows team members to note what tools and resources they need to be most effective in their roles.
* Not all needs on the assessment will likely be filled. However, the assessments allow top management to plan for the fulfillment of those needs if deemed appropriate.
* Needs assessments and management reviews are best completed leading up to annual budget cycles. Leadership can then make informed decisions about what expenses might arise in the coming year. For example, a needs assessment might uncover the need for a number of computer upgrades, new welding helmets, etc.
Changes that could affect the system. This might include;
- Staff turnover and retirements
- Regulatory changes
- Product changes affected by supply chain, i.e. substitutions that can cause unintended consequences down the line
- Changes in government regulation
The annual management review should result in action items to be completed in relation to the above-mentioned list and an assigned owner of each action item.
Step 6: Quality Policy Manual
Once a company has documented their quality management system as described above, documenting the coordination of the many parts is necessary. This is the purpose of the Quality Policy Manual. The manual is going to be the 30,000-foot view of the entire system. It will give the reader a broad understanding of the system and link to additional documentation, i.e. procedures, for more in-depth information.
The Quality Policy Manual should include, but is not limited to;
Part 1: Mission, Vision, Values and Quality Objectives
Part 2: Administrative Requirements
- Organization has appropriate insurance coverages.
- Outline of organizational structure, to include;
* Hierarchical chart of personal showing reporting structure
* References job descriptions
Part 3: Resource Requirements
- This should cover personnel, facilities and equipment, and if relevant, any third party contracting.
Personnel:
· The goal is to ensure a company has enough personnel to carry out its functions and those personnel are qualified. Reference to HR policies and procedures as well as job descriptions.
· An overarching HR procedure should outline general hiring, onboarding, evaluations, and ongoing training processes as well as the records to be created during those processes. This document should link to a number of other documents.
· With regard to having enough staff, the HR procedure should reference the annual management review and annual needs assessment.
Facilities and Equipment:
· The goal is to ensure that the organization has all the facilities and equipment necessary to carry out all functions properly and efficiently.
· It is recommended that a company develop a procedure for regularly, annually at a minimum, that seeks to evaluate facilities and equipment for needed improvements. The simplest way to accomplish this is by referencing the annual management review, outlining specific agenda items for said meeting that would incorporate facilities and equipment needs, and of course referencing the annual needs assessment.
Third Party Contracting
· If relevant, outlining any third-party contractors and the criteria for selecting an appropriately qualified contractor. For example, first stage or second stage manufacturers would need to identify the other manufacturing group with which they work.
· The criteria will vary, but at a minimum should include the company’s compliance with applicable federal regulation for trailer construction.
This document and associated sample materials (the “Document”) and the guidance are produced by NATM as a service to its membership. The Document is intended to be used as a general reference only and not meant to be a complete guide for the development of Quality Management Systems. Nor is this Document intended to provide legal advice; if legal advice or other expert assistance is required, the user should seek the services of legal counsel or other competent professional. The use of this Document is entirely voluntary and the determination of its applicability and suitability for any particular use is the sole responsibility of the user. Neither NATM nor its officers, directors, members, employees, or contractors (collectively, “NATM”) assume responsibility for or warrant the accuracy of the contents of this Document. NATM cannot guarantee and disclaims any responsibility for any specific result relating to the use of this Document and for any errors or omissions contained in the Document. It also disclaims any liability for any loss, damage, or injury of any kind arising out of the use of this Document, and all those using the Document agree, as a condition of its use, to release NATM from any and all liability, claims, losses, or damages of any kind or nature arising out of or relating to its use. NATM expressly reserves the right, in its sole discretion, to update, revise, and otherwise modify the Document from time to time as it sees fit and to do so without furnishing specific notice, or the revised edition itself, to prior recipients or current users of the Document.