Quality Management in Plastic Injection Molding

Our quality management

What do we mean by quality? Below, we provide an overview of our understanding of quality and the principles that guide our daily work and help us ensure quality. Our Quality Management Manual serves as the foundation for this, and the following information is taken from it.

Quality Management

QM–Manual Excerpts from the current issue, No. 24 Rev 02 SKT Solmser Kunststofftechnik

Company Profile

SKT Solmser Kunststofftechnik GmbH specializes in the manufacture and assembly of technical plastic injection-molded parts made from virtually all common thermoplastics. Our many years of experience in design and manufacturing form the foundation of our industry-specific expertise.

We have a machine park equipped with ENGEL and ARBURG injection molding machines with clamping forces ranging from 50 to 6,000 kN. This enables us to manufacture plastic parts weighing between 0.1 grams and 2.7 kilograms. Most of the machines are equipped with handling robots.

We process nearly all common raw materials, including ABS, PA, PE, PP, PET, PMMA, PVC (soft and hard), PC, POM, PS, and TPE in various Shore hardnesses. Depending on requirements, custom coloring, the addition of additives and fillers, or V0-compliant designs are possible.

Our close collaboration with the modern and high-performance toolmaking division of our sister company, BKT Bauer Kunststofftechnik in Sulzbach-Laufen, enables us to implement even specific customer requirements quickly and reliably.

1.0 Company Profile

QM Manual 1.2

Enforcement of our QM system

Our quality management system forms the foundation for our daily operations and for ensuring our quality. The applicable principles and processes are set forth in our QM Manual and the associated procedure and process descriptions.

The quality management system has been implemented by management and is binding for all employees and departments. This ensures that the principles and processes defined therein are implemented and adhered to throughout the entire company.

Our quality management system is, of course, certified according to DIN EN ISO 9001:2015.

1.1 QM System Enforcement

QM Manual 1.3

Overview of the Processes

1.2 Overview of the Processes

QM Manual 1.4

Quality Management System

ISO 9001: 2015 certified

Our quality management system complies with DIN EN ISO 9001:2015
Quality policy and quality objectives are defined in the QM manual
Quality objectives are regularly reviewed for compliance
Management redefines quality objectives annually
All critical processes are documented
All documents in use are current and valid
Outdated documents are replaced

The quality management system applies to the entire company. Every employee is responsible for ensuring compliance with quality standards in their respective areas.

This is how we ensure the effectiveness of our quality management system and, at the same time, consistently meet our customers' quality requirements.

2.0 QM System

QM Manual 2.0

QM Process Model for Sales

2.1 QM Process Model

QM Manual 2.1

QM Process Model KVP

Continuous Improvement (KVP)

2.2 QM Process Model

QM Manual 2.1

Quality Management Process Model for Production

2.3 QM Process Model

QM Manual 2.1

QM Documentation

Our quality management system includes defined quality objectives, processes, and procedures.
Work and inspection instructions support implementation in day-to-day operations.
All relevant documents are reviewed and approved.
We ensure that work is always performed using current and valid documents.
Changes are documented, and older versions are archived.
Relevant data and records are secured and protected.
Responsibilities for creation, approval, maintenance, and archiving are clearly defined.

2.4 QM Documentation

QM Manual 2.2 – 2.3.4

QM Management

At SKT Solmser Kunststofftechnik, responsibility for quality is governed by clear structures and well-defined areas of responsibility. Our quality policy and quality objectives are formally established and are regularly reviewed and adjusted. The quality management system is also evaluated and refined annually by management.

3.0 Management

QM Manual 3.0

Management Commitment

Management is committed to continuously developing and improving the quality management system. In doing so, we focus on our customers’ requirements as well as legal and regulatory requirements.

Our quality policy and quality objectives are regularly reviewed and adapted to changing requirements. All employees contribute to ensuring compliance with the established quality standards and to identifying and correcting deviations at an early stage.

3.1 Management Commitment

QM Manual 3.1

Customer Focus

We consistently tailor our work to our customers’ needs. In doing so, we review and clarify requirements, scope of services, price, and delivery time well in advance of an order.

In the event of changes or special requirements, we coordinate closely with the relevant departments. This allows us to establish clear conditions for reliable order processing and high customer satisfaction.

3.2 Customer Focus

QM Manual 3.2

Quality Policy

Our approach to quality is based on three guiding principles:

We align our actions with the requirements and expectations of our customers.
Quality and reliability result from responsible and skilled work.
We identify risks and opportunities for improvement early on and continuously refine our processes.

In this process, every employee takes responsibility for the quality of their work and contributes to improving our processes.

3.3 Quality Policy

QM Manual 3.3

Quality Objectives

Our quality objectives are regularly established and reviewed. The following areas are of particular focus:

Avoiding and reducing valid complaints
A consistently low scrap rate
High and consistent delivery quality
Continuous improvement of our processes

Management regularly reviews progress toward achieving quality objectives and takes appropriate action as needed.

3.4 Quality Objectives

QM Manual 3.4.1

Quality Organization

Quality is firmly embedded in our organizational structure. Responsibilities and areas of authority are defined for all relevant departments:

Executive Management
Quality Management / Quality Assurance
Department Management
Production and Manufacturing Planning
Work Planning
Setup Operators and Shift Supervisors
All Employees

Every employee is responsible for the quality of their work. The goal is to work as error-free as possible. If quality risks or deviations are identified, they are reported promptly and appropriate measures are taken. In doing so, the established work procedures and quality requirements must be followed.

3.5 Quality Organization

QM Manual 3.5.3

Resource Management

We use our resources strategically to...

... continuously improve our quality management and ensure customer satisfaction,
to train and develop employees in accordance with their responsibilities,
to provide the necessary infrastructure and appropriate work equipment,
to create a work environment that enables reliable, high-quality production.

4.0 Resource Management

QM Manual 4.0

Resource Management

Human Resources

Our employees possess the necessary qualifications and skills for their respective roles. Targeted onboarding and training ensure that they are familiar with the necessary processes and requirements. Through training and continuing education, we continuously develop their professional knowledge. Taking responsibility for the quality of one’s own work is an essential part of our daily work.

Investment Planning

Necessary investments are regularly reviewed and carefully planned. In doing so, we take into account the requirements for quality, efficiency, and reliable production. Investments in machinery, equipment, and other operating resources help us maintain our production at an appropriate technical level over the long term and implement necessary improvements.

Infrastructure

We provide the infrastructure required for our manufacturing operations in a manner that meets our needs and serves its intended purpose, and we maintain it accordingly. This includes buildings and workspaces as well as machinery, manufacturing equipment, and transportation and storage facilities. The necessary office, IT, and communications technology is also part of our company’s infrastructure.

Work Environment

A suitable work environment creates the conditions necessary for reliable, high-quality production. This includes well-equipped and safe workstations, suitable working conditions, as well as sufficient space and adequate lighting. Cleanliness and order also support smooth operations and contribute to consistent product quality.

Information Management

Our IT systems support the processing, management, and provision of the information required for our work. This includes, in particular, production and corporate data. We ensure that information relevant to the respective tasks is available and processed in accordance with requirements. In this way, we create a reliable foundation for our processes and their documentation.

4.1 Resource Management

QM Manual 4.2 – 4.6

Product Development

The QM procedure manual and process description outline the procedures that ensure customer requirements are correctly identified and errors in collaboration are avoided. This is achieved by:

Clear definition of requirements
Feasibility studies
Consideration of legal requirements
Consistency between inquiry, quote, order, and confirmation
Clarifications with the customer regarding order changes

5.0 Product Development

QM Manual 5.0 – 5.1

Customer Communications

The Technical Sales department is responsible for communicating with customers. For overarching and strategic issues, management is involved. This also applies to customer complaints; in such cases, Quality Assurance is involved. The following communication channels, among others, are used:

Product information is provided to our customers by the sales department
Procedures for handling inquiries, contracts, and order processing are established
Customer feedback is forwarded to the relevant departments via the Technical Sales department for further action

5.1 Customer Communication

QM Manual 5.1.1

Development & Design

Development and Design

Based on drawings, samples, or sketches, the necessary design documents for tools and manufacturing are created.
New tools are designed according to the respective customer specifications.
Before series production begins, the tools are sampled internally, and the results are documented using sample parts and test reports.
Approval for the tool and series production is granted in consultation with the customer.
SKT does not conduct its own product development. The specifications for our manufacturing are provided by the customer.

5.2 Development & Design

QM Manual 5.2 – 5.3

Procurement, Suppliers and Goods Receiving

Procurement

We procure raw materials, purchased parts, and other necessary materials in accordance with defined requirements. In doing so, we verify the required quantities and specifications, clearly formulate purchase orders, and monitor delivery dates. Incoming materials are inspected based on their importance and the respective requirements.

Supplier Selection

When selecting our suppliers, we place particular emphasis on quality, on-time delivery, value for money, and cooperation. Supplier performance is evaluated on a regular basis and is taken into account in the ongoing selection of suppliers. If suppliers or materials are specified by our customers, or if materials are provided by them, the corresponding customer specifications apply.

Receiving Goods

Delivered materials and purchased parts and goods are inspected upon receipt in accordance with the specified requirements. Raw materials are identified based on the corresponding delivery and inspection documents. Purchased parts and parts provided by suppliers are also inspected for compliance with the specified quality characteristics.

5.3 Procurement

QM Manual 5.5 – 5.5.4

Manufacturing & Traceability

Manufacturing

Our manufacturing is planned based on the respective orders and carried out on schedule. Before series production begins, machines and equipment are set up accordingly, and the necessary production and quality specifications are verified. Quality is regularly monitored during ongoing production. This includes, among other things:

Production approval prior to the start of series production
Inspection of manufactured parts during ongoing production
Regular monitoring and testing of specified quality characteristics
Preventive maintenance and servicing of machines and equipment

Traceability

The unique identification of materials, finished parts, and packaging helps prevent mix-ups and ensures proper assignment within the manufacturing process.

Relevant information such as part numbers, production data, and other required identifiers is recorded. Tools are also uniquely identified and can be assigned to the respective manufacturing process.

Traceability all the way back to the specific material batch used is, of course, possible. To this end, batch information for the raw materials used is documented and stored with the finished product.

5.4 Manufacturing

QM Manual 5.6 – 5.7

Performance Evaluation

Through measurements and analyses, we ensure the quality of our products and the effectiveness of our quality management system. At the same time, we identify opportunities for improvement at an early stage and implement appropriate measures for continuous improvement.

6.0 Performance Evaluation

QM Manual 6.0

Customer Satisfaction

Measuring Customer Satisfaction

We evaluate our customers' satisfaction based on various factors:

Quality of Our Products and Services
Reliability and Quality of Order Processing
Adherence to Deadlines and Quantities, as well as Flexibility
Collaboration and Direct Feedback from Our Customers

Feedback from customer meetings and our ongoing collaboration is incorporated into our regular customer satisfaction assessments. This allows us to identify areas for improvement and take appropriate action as needed.

6.1 Customer Satisfaction

QM Manual 6.1.1

Audits on a regular base

The effectiveness of the quality management system is verified through regular internal audits. These audits determine whether quality measures have been established, communicated, adhered to, and documented in a traceable manner. All business units are audited systematically and in a risk-based manner to prevent errors and continuously improve processes.

The audits are scheduled in the audit program for a three-year period. A detailed audit plan is prepared for each audit no later than ten days in advance. The audit process includes an opening and closing meeting as well as interviews with managers and employees.

The results are documented in an audit report in accordance with ISO 9001:2015. This report specifically includes findings, nonconformities, recommendations, and required corrective actions. The actions are tracked during continuous improvement meetings, and their effectiveness is verified during the follow-up audit.

In addition, product or process audits can be conducted upon customer request. Manufacturing and assembly processes, as well as quality management processes, are continuously monitored and evaluated using defined key performance indicators.

6.2 Audits

QM Manual 6.1.2 – 6.1.4

Continuous Product Monitoring

Production Approval: The set-up operator sets up the machine and inspects the first parts produced based on the specified inspection points. The machine is adjusted until all specifications are met. Subsequently, Quality Assurance (QA) inspects a random sample and, if the results are satisfactory, grants approval for series production. The approved part is marked, and the approval is documented on the production control sheet.

Inspection during mass production: During mass production, the operators perform the specified visual inspections. Random inspections are conducted and documented by shift supervisors or setup technicians. In addition, Quality Assurance (QA) regularly inspects samples from ongoing production. In the event of deviations, the affected parts are immediately held, the defect is analyzed, and corrective actions are initiated. Production quantities, good parts, and scrap parts are documented at the end of each shift or order.

Final Inspections: At the end of each shift, as well as during packaging or assembly, final visual inspections are performed, along with a check of the work order and quantity. Upon customer request, additional final inspections are conducted and documented separately. If the inspection documents are included with the shipment, this is noted in the shipping order.

Initial Sample and Sampling Inspections: Initial sample and sampling inspections are performed according to customer requirements and based on customer drawings as well as additional specifications. The results are documented in an initial sample inspection report (EMPB). For sampling, only the characteristics affected by changes are generally inspected. Initial samples and sampling documentation are not released to the customer until after internal approval.

6.3 Production Monitoring

QM Manual 6.1.5

Continuous Improvement

We apply continuous improvement to our products, processes, and our quality management system with the goal of enhancing their effectiveness so that we are able to manufacture products in accordance with specified customer requirements. We aim to achieve improvements in quality, lead times/delivery dates, workflows, and costs.

7.0 Improvement

QM Manual 6.4

Continuous Improvement

We achieve continuous improvement in the effectiveness of our quality management system by establishing and applying the following points:

Implementation of the Quality Policy
Establishment of individual quality goals with an annual comparison of actual results against targets
Specific actions resulting from internal audits
Actions resulting from meetings
Targeted error correction
Preventing potential errors with appropriate measures
Assessment and actions resulting from the annual management review

7.1 Continuous Improvement

QM Manual 6.4.1

Corrective and Preventive Measures

Our goal is to systematically identify the causes of errors and to eliminate them permanently or prevent them from occurring. As a general rule:

Causes of errors are systematically analyzed.
Appropriate corrective and preventive actions are defined and documented.
The implementation of these actions is monitored, and their effectiveness is verified.
Complaints and deviations are handled in a structured manner.

Errors that occur internally at SKT or externally at the customer's site are handled using a digital complaint management system. Depending on the specifications, the 8D report format is also used. Potential sources of error are minimized by:

Regular CIP meetings and FMEA analyses
Targeted maintenance of our production facilities
Implementation of necessary investments
Employment of appropriately trained personnel
Review of processes through internal audits

7.2 Correction and Prevention

QM Manual 6.4.2

Quality at SKT

Our approach to quality, qm system, and quality assurance processes...