You are on page 1of 33

Revision S

Quality Manual 03.11.2015


Page 1 of 33

Quality Manual

Speck Pumpen Walter Speck GmbH & Co. KG


Speck PUMPEN Systemtechnik GmbH
Speck PUMPEN Vakuumtechnik GmbH

This Quality Manual must not be copied or reproduced in any other form!

Date Division Name Signature

Created/revised 08.01.2015 QM Mr Hahn

Reviewed 09.01.2015 QM Mr Vogel

Approved 09.01.2015 GF Mr Krger

QM manual according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 2 of 33

Index:
0.1 Preface .................................................................................................................................. 5
0.2 Process-oriented approach ................................................................................................... 5
0.3 Relation to ISO 9004 ............................................................................................................. 6
0.4 Compatibility with other management systems ..................................................................... 6
1 Application area ................................................................................................................................ 7
1.1 Purpose and scope................................................................................................................ 7
1.2 Introduction and application .................................................................................................. 7
1.3 Structure of the Quality Manual ............................................................................................. 7
1.4 Distribution of the Quality Manual ......................................................................................... 8
1.5 Regulations of the revision service ........................................................................................ 8
2 Normative references ....................................................................................................................... 8
3 Organisation and responsibilities ..................................................................................................... 8
3.1 Company's profile .................................................................................................................. 8
3.2 Organisational structure ........................................................................................................ 9
3.3 Company philosophy ........................................................................................................... 10
4 Quality management system .......................................................................................................... 10
4.1 General requirements............................................................................................................... 10
4.1.1 Objectives of the QM system ....................................................................................... 10
4.1.2 Scope of the QM system .............................................................................................. 11
4.2 Documentation requirements .............................................................................................. 11
4.2.1 General ......................................................................................................................... 11
4.2.2 Quality Manual ............................................................................................................. 12
4.2.2.1 Process description (PB) / process instructions (VA) ................................ 12
4.2.2.2 Work instructions (AA) ............................................................................... 12
4.2.2.3 Documents of proof ................................................................................... 13
4.2.3 Document control ......................................................................................................... 13
4.2.3.1 Objective of the documentation ................................................................. 13
4.2.3.2 Scope......................................................................................................... 13
4.2.3.3 Definitions .................................................................................................. 13
4.2.4 Control of records ......................................................................................................... 14
4.2.4.1 Preparation, release, introduction, maintenance ....................................... 14
4.2.4.2 Documentation control ............................................................................... 14
4.2.4.2.1 Classification system .............................................................................. 14
4.2.4.2.2 Availability of documents ........................................................................ 15

QM manual according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 3 of 33

4.2.4.2.3 Revision management ............................................................................ 15


5 Management responsibility............................................................................................................. 15
5.1 Management commitment ................................................................................................... 15
5.2 Customer focus ................................................................................................................... 15
5.3 Quality policy ....................................................................................................................... 16
5.4 Planning ............................................................................................................................... 17
5.4.1 Quality targets .............................................................................................................. 17
5.4.2 Planning of the QM system .......................................................................................... 18
5.5 Responsibility, authority and communication ...................................................................... 18
5.5.1 Management representative ........................................................................................ 18
5.5.2 Internal communication ................................................................................................ 19
5.6 Management review ............................................................................................................ 19
5.6.1 General ......................................................................................................................... 19
5.6.2 Review input ................................................................................................................. 20
5.6.3 Review output ............................................................................................................... 20
6 Resource management .................................................................................................................. 21
6.1 Provision of resources ......................................................................................................... 21
6.2 Human resources ................................................................................................................ 21
6.2.1 General ......................................................................................................................... 21
6.2.2 Competence, awareness and training.......................................................................... 21
6.3 Infrastructure ....................................................................................................................... 21
6.4 Work environment ............................................................................................................... 22
7 Product realisation .......................................................................................................................... 22
7.1 Planning of product realisation ............................................................................................ 22
7.2 Customer-related processes (contract review) ................................................................... 22
7.2.1 Determination of requirements related to the product.................................................. 22
7.2.2 Review of requirements related to the product ............................................................ 23
7.3 Design and development ..................................................................................................... 23
7.3.1 Design and development planning ............................................................................... 23
7.3.2 Design and development inputs ................................................................................... 23
7.3.3 Design and development outputs ................................................................................. 23
7.3.4 Design and development review .................................................................................. 23
7.3.5 Design and development verification ........................................................................... 24
7.3.6 Design and development validation ............................................................................. 24
7.3.7 Control of design and development changes ............................................................... 24
7.4 Purchasing ........................................................................................................................... 24
7.4.1 Purchasing process ...................................................................................................... 24

QM manual according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 4 of 33

7.4.2 Purchasing information ................................................................................................ 25


7.4.3 Verification of purchased products ............................................................................... 25
7.5 Production and service provision ........................................................................................ 25
7.5.1 Control of production and service provision ................................................................. 26
7.5.2 Validation of processes for production and service provision ...................................... 26
7.5.3 Identification and traceability ........................................................................................ 26
7.5.4 Customer property........................................................................................................ 27
7.5.5 Preservation of product ................................................................................................ 27
7.5.6 Export control & customs expert (ECCE) ..................................................................... 27
7.6 Control of monitoring and measuring devices ..................................................................... 28
8 Measurement, analysis and improvement ..................................................................................... 28
8.1 General ................................................................................................................................ 28
8.2 Monitoring and measuring ................................................................................................... 28
8.2.1 Customer satisfaction ................................................................................................... 28
8.2.1.1 Maintenance and customer service ........................................................... 28
8.2.1.2 Monitoring of customer satisfaction ........................................................... 29
8.2.2 Internal audit................................................................................................................. 29
8.2.3 Monitoring and measuring of processes ...................................................................... 29
8.2.4 Monitoring and measuring of the product .................................................................... 30
8.2.4.1 Testing schedule ....................................................................................... 30
8.2.4.2 Incoming goods inspection ........................................................................ 30
8.2.4.3 In-process inspection (self-monitoring) ..................................................... 30
8.2.4.4 Final inspection .......................................................................................... 30
8.3 Control of non-conforming products .................................................................................... 31
8.4 Data analysis ....................................................................................................................... 31
8.5 Improvement........................................................................................................................ 31
8.5.1 Continuous improvement ............................................................................................. 31
8.5.2 Corrective action .......................................................................................................... 31
8.5.3 Preventive action .......................................................................................................... 32
Current revision status ........................................................................................................................... 33

QM manual according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 5 of 33

Introduction

0.1 Preface
The products and services of our company increasingly contribute to successful business operations
of our customers. At the same time, the requirements of our customers concerning the quality of our
portfolio become more and more stringent.

The quality level of our products and services is amongst others influenced by our competitors in the
market.

These framework conditions present a continuous challenge to us, SPECK PUMPEN Walter Speck
GmbH & Co. KG, SPECK PUMPEN Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik
GmbH, to consistently match the quality of our products to the demands of our customers.

Based on the aforementioned principle, this Quality Manual (QM) describes the quality management
system (QM system) of SPECK PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN
Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik GmbH according to DIN EN ISO
9001:2008 and is binding upon all employees.

All employees are assigned with the implementation of this Quality Manual in order to meet our quality
policy and achieve our quality targets by:

observing the documentation of this quality management system and meeting the standards
contained therein
actively contributing to a continuous advancement of this documentation.

0.2 Process-oriented approach


Our company has introduced a quality management system according to DIN EN ISO 9001:2008 and
strictly follows a process-oriented approach.

Continuous improvement of the quality management system

Inter- Area of responsibility of the


Inter-
ested executive management ested
parties parties

Satis-
Resource Measurement, analysis faction
management and improvement

Require-
ments Input Product Product Result
realisation

Added value Information Grade of improvement


process
QM manual according to DIN EN ISO 9001: 2008
Revision S

Quality Manual 03.11.2015


Page 6 of 33

0.3 Relation to ISO 9004


The contents of the EN ISO 9004:2008 standard have been considered in the implementation of the
quality management system.

0.4 Compatibility with other management systems


We contribute towards preserving the environment by disposing and recycling waste material in
compliance with legal requirements.
ISO 9004:2008, see 0.3

QM manual according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 7 of 33

1 Application area

1.1 Purpose and scope


This Quality Manual of SPECK PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN
Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik GmbH has been developed to
communicate the integration of our quality management system in our organizational structure based
on DIN EN ISO 9001:2008 to our internal and external customers. As a central document of our quality
management system, this Manual describes relationships between all quality-related documents
(Quality Manual, process descriptions, work instructions, job descriptions and form sheets) and
represents a basic prerequisite for the DIN EN ISO 9001:2008 certification.

The Quality Manual has another important task. It provides the employees of our company with a
getting-started guide to inter- and intradivisional procedures. Our employees are enabled to transfer
the requirements of the standard to their own individual work processes and meet them accordingly.
Above all, we consider the application of quality management principles in everyday processes as a
basic prerequisite for the effectiveness of such a system.

1.2 Introduction and application


Every employee has been made familiar with those principles of the quality management system
which are important to him/her. The scope of each quality document - except for the form sheets - is
apparent from the document itself.

"It is a primary duty of every employee to implement the QMS documentation applicable to his/her
area of operation".

Within the scope of introductory courses, all employees have been made familiar with the quality
documentation, ensuring a permanent implementation of our quality guidelines in all divisions of
SPECK PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN Systemtechnik GmbH and
SPECK PUMPEN Vakuumtechnik GmbH. Every employee has access to our corporate quality
documentation as copies thereof are stored in all divisions.

Every employee is obliged to

make himself/herself familiar with the quality management system,


implement quality documentation applicable to the individual working areas and procedures.
Area-specific documents are available wherever they are required.

1.3 Structure of the Quality Manual


The Quality Manual is divided into sections. The individual sections are divided into subsections,
paragraphs and sub-paragraphs, which basically follows the structure of the DIN standard.

QM manual according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 8 of 33

1.4 Distribution of the Quality Manual


The editor of the Quality Manual is the Head of Quality Management or his/her deputy. The current
version of the Manual always refers to the Intranet version of SPECK PUMPEN Walter Speck GmbH
& Co. KG, SPECK PUMPEN Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik GmbH.

1.5 Regulations of the revision service


In case of organisational changes or changes concerning internal responsibilities, Quality
Management has to be informed by the respective division to be able to modify the Quality Manual
accordingly. All revisions are documented in the Annex.

2 Normative references
DIN EN ISO 9000:2008
DIN EN ISO 9001:2008
DIN EN ISO 9004:2008
CE
ISO 19011 audit standards
DIN EN 13980:2002

3 Organisation and responsibilities


3.1 Company's profile
In 1909, Daniel Speck founded a company which manufactured and developed pumps and
aggregates.
The initial name of the company was:

SPECK - PUMPEN , Daniel Speck & Soehne , Nuernberg, later Hilpoltstein

It became the parent company of all other companies named SPECK including

SPECK - Kolbenpumpenfabrik,
SPECK - Pumpenverkaufsgesellschaft and
SPECK - PUMPENFABRIK Walter Speck KG in 91154 Roth,

the latter was founded in 1960.

SPECK PUMPEN Walter Speck GmbH & Co. KG was rebranded in August 1998. In January 2003,
SPECK PUMPEN Systemtechnik GmbH was founded.
All companies carrying the name of SPECK are legally independent, although they have entered an
agreement to produce different pumps and pump types.
SPECK PUMPEN Walter Speck GmbH & Co. KG has specialised in liquid pumps. SPECK
PUMPEN Systemtechnik GmbH produces magnetically coupled pumps and SPECK PUMPEN
Vakuumtechnik GmbH vacuum pumps. The companies mainly produce pumps for technical
requirements, which are sold to industrial customers from the chemical, food, medical and
pharmaceutical sector.

QM manual according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 9 of 33

3.2 Organisational structure

As of November 2015

Executive Board
Mr Krger, Mrs Krger-Steindorf,

Members of the Executive Management


Dr. Thomas Krger, Dr.-Ing. Hhre

Air cargo security Export Control Energy Manager IT Repairs Occupational Safety
manager Ms Beringer Mr Vogel Dipl.-Kfm. Hahn, MBA Mr Peter Mr Knoblich (TV)
Mr Wiedmann
Ms Beringer Subordinated divisions
Electrical Service
Facility management

Quality Management Accounting


Dipl.-Kfm. Hahn, MBA Mr Putz
Subordinated divisions Subordinated divisions
Quality Control Financial Accounting
Explosion Protection Human Resources
Payroll Accounting

ATEX Certification
Manager Mr Stark, Mr.
Wiedmann, Mr. Emmerich

Sales Management Order centre Purchasing Production Technology


Mr Wagner Mr Himml Mr Winkler All divisions are directly Dr.-Ing. Hhre
interim subordinated to the
National: Mr Wagner
Executive Management
Europe: Dipl.-Ing. Rasp
Export: Mr Vierlinger

Subordinated divisions Subordinated divisions Subordinated divisions Subordinated divisions Subordinated divisions
Secretary Material Planning own Material Planning Purchased Incoming Goods Store Development
Sales Finished Products Parts Mechanic Processing Construction
Service Master Data Maintenance Auditing Internal Transport Laboratory
Shipping / Exports Preliminary Costing Imports Assembly Technical Documentation
Head Office Production Planning and Strategic Purchasing Paint Shop / Shipping
Control

= Supporting divisions = Indirectly / directly value adding divisions

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 10 of 33

3.3 Company philosophy


Ever since their foundation, SPECK-PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN
Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik GmbH have considered themselves
as innovative and learning companies striving for long-term strategic thinking instead of short-term
profit growth. This attitude is important for all employees to be ready to face global competition.
Training and further education of our employees plays an important role in our company. We do not
only focus on the transfer of technical know-how but also strive for developing the overall personality
of our employees. Satisfied employees and a positive working climate form the groundwork for our
company's success. The core essence of our business activities is the customer with his wishes,
suggestions and requirements. We particularly concentrate on developing solutions in close
cooperation with our customers to offer perfectly tailored solutions for existing problems.

4 Quality management system


4.1 General requirements
All processes performed at SPECK PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN
Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik GmbH were identified and
documented within the scope of process descriptions, which have been supplemented by working and
test instructions, check lists and forms where required.
The process owners are defined in the corresponding process descriptions. Their tasks and
competencies are specified in the functional descriptions.

Applicable documents:
Process instructions Process description
PB 00

4.1.1 Objectives of the QM system


Our quality management aims at implementing the corporate quality policy by meeting the quality
targets of the company and its individual divisions.
The quality management system, which has been introduced for this purpose, shall

make operation sequences as well as task specifications, competencies and


responsibilities transparent,
document and support all quality management activities, provide a guideline for
employees and monitor business processes.

The quality management system consists of three elements

quality-related corporate policy and quality targets,


quality organisation and critical activities described in the processes (all resources are
identified here which are essential for maintaining the high quality of our products to be
able to meet customer requirements in the long term),
quality documentation

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 11 of 33

4.1.2 Scope of the QM system


The quality management system of our company describes and supports the products and services of
our company.
It applies to all divisions of SPECK-PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN
Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik GmbH.

4.2 Documentation requirements


4.2.1 General
The quality management system has been tailored to the overall organisation of our company and
consists of the following quality documents (see Fig. 1 "Documentation pyramid")

Quality Manual (QM)


Process descriptions (PB) / process instructions (VA)
Work instructions (AA) and form sheets
Documents of proof (quality records)
Quality-related job descriptions

The procedure regulating the preparation, verification, release and control of the available quality
documents is described in the following section of this manual.

Quality Manual
The company

Process descriptions / process instructions


for groups of employees

Work instructions
for individual employees

Documents of proof
reviewable documents proving that our specifications
comply with our activities
delivery note, invoice, maintenance check, quality check, orders etc.

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 12 of 33

Fig. 1: Documentation pyramid of the quality management system

4.2.2 Quality Manual


The Quality Manual (QM) contains
the quality policy and quality targets guaranteeing the required quality of products and
services,
description of organisational and operational structure as well as
tasks, responsibilities and competencies within the scope of the quality management
activities of all corporate bodies involved in added value activities.

The manual serves as

a means of internally and externally communicating information on the quality


management system,
framework and interface for the documentation of the quality management system
(relation matrix for the process instructions),
basic training document (overview for new employees),
framework for the planning of internal and external audits.

The chapters are divided according to DIN EN ISO 9001:2008

4.2.2.1 Process description (PB) / process instructions (VA)

The partially interdivisional process descriptions (PB) / process instructions (VA) include instructions
and flow charts of process-oriented, critical, i.e. quality-related activities within the value-added chain
of SPECK-PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN Systemtechnik GmbH and
SPECK PUMPEN Vakuumtechnik GmbH.

The critical activities were

identified beforehand within the scope of a comprehensive survey including all business
divisions,
verified and approved in cooperation with the respective divisions and employees of
SPECK-PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN Systemtechnik
GmbH and SPECK PUMPEN Vakuumtechnik GmbH during workshops (group talks).

Special importance has been attached to the identification, review and observance of the internal
customer-supplier relationships. The appointment of process owners accounts for the requirements
concerning internal coordination and moderation resulting thereof. This procedure, which involves all
company levels, presents the basis for implementing the aforementioned quality targets of our
corporate quality management system.

4.2.2.2 Work instructions (AA)

The work instructions (AA) are detailed workplace-related descriptions of individual activities. The
main task of work instructions is to further detail the steps specified in the process descriptions. They
contain all information required for implementing these steps, i.e. also organisational and technical
know-how of the company. In conjunction with the form sheets, the work instructions are the tools of
our employees.

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 13 of 33

4.2.2.3 Documents of proof

Quality is attained by:

a. deployment of qualified personnel


b. adequate planning
c. application of suitable tools and processes
d. associated regulations of work and test requirements as well as compliance with legal
regulations and directives (e.g. Ex protection directive 94/9/EC)
e. supervision and technical instructions

Quality is proven during and after completion of the required measures by evaluating / monitoring the
work activities and certifying the quality status in writing.

The quality assessments are performed by competent employees who were directly assigned with the
completion of the tasks. These quality records which are prepared within the scope of "self-monitoring"
are used as quality certificates. Further documents of proof may be delivery notes, invoices,
maintenance checks, quality assessments, orders, etc.

4.2.3 Document control

4.2.3.1 Objective of the documentation

The regulations on the control of quality documents stipulated by SPECK-PUMPEN Walter Speck
GmbH & Co. KG, SPECK PUMPEN Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik
GmbH guarantee the effectiveness of the quality management system. Properly controlled quality
documents are instructions concerning compliance with customer requirements and instruments for
monitoring and advancing the quality management system.

4.2.3.2 Scope

The regulations governing preparation, release, introduction and maintenance of quality documents
(document concept) as well as the availability and modification (document control) apply to all
divisions of SPECK-PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN Systemtechnik
GmbH and SPECK PUMPEN Vakuumtechnik GmbH.

4.2.3.3 Definitions

Quality documents are quality-related documents on the development and maintenance of


the quality management system, which are controlled by the Quality Manager.
Quality records are quality-related documents on compliance with customer requirements,
which are controlled by the process owners.

The Quality Manager is exclusively responsible for the monitoring of the document control.

Applicable documents:
Process instructions Process description
VA 01
VA 08
VA 11
VA 15

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 14 of 33

4.2.4 Control of records

4.2.4.1 Preparation, release, introduction, maintenance

Quality documents are prepared, issued and distributed to the respective employees by the individual
divisions in cooperation with the Quality Manager and/or Explosion Protection Officer.
The preparation of documents lies in the area of responsibility of all employees. Reviews are
performed by the process owner, who is supported by the Quality Manager. The same applies to the
instruction of the division staff concerning introduction, observance and advancement/maintenance of
the documents. If documents require update, the Quality Manager initiates the revision process and
releases the quality document.

Applicable documents:
Process instructions Process description
VA 02
VA 13

4.2.4.2 Documentation control

4.2.4.2.1 Classification system

All documents of the quality management system have an ID number (document number) and a
document name. The numbers of the diverse quality documents are structured as follows:

Document number of QM manual


Example "Quality manual (QM) - revision A / date (last revision)

Document number of process instructions


VA = process instruction
XX = VA number
01.01.01 = date (issue date)
A = revision status

Document number of process descriptions


PB = process description
0XXX = PB number (no. corresponds to section in manual)
Modification date= revision status

Document number of work instructions:


AA = work instruction
001 = consecutive number of work instruction
e.g. a = revision status

Document number of form sheets:


0001-"Name/title" (=consecutive numbers)
01/01/01 = issue 01/01/01 (revision and/or issue date)

Quality documents which are not subject to this classification system are:

instructions of the board of directors


EDP user manuals
division folders

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 15 of 33

4.2.4.2.2 Availability of documents

The availability of quality documents is ensured by a demand-based distribution list. The heads of the
divisions are responsible for availability of the documents in their respective divisions. The Quality
Manager does not hand out the Quality Manual and process descriptions physically. The documents
are available via the Intranet of SPECK-PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN
Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik GmbH. It lies in the area of
responsibility of the heads of the divisions to forward quality-related information and, if required, print-
out the quality documents for the individual divisions. This also applies to the update of outdated
documents.
All other documents (form sheets, work instructions, quality records, etc.) are issued by the Quality
Manager.
Quality documents exempt from this classification system are distributed by the corresponding editor
or creator.

4.2.4.2.3 Revision management

Revisions within the scope of maintenance and advancement of quality documents are the
responsibility of all employees. Revised documents have to be examined by those bodies which have
already reviewed the first issue unless a different body is assigned with this task. The Quality Manager
has to release both new and revised documents.
The Quality Manager guarantees that all steps of the revision process are completed and is
responsible for the exchange and issuance of the revised documents.

5 Management responsibility
Applicable documents:
Process instructions Process description
PB 05

5.1 Management commitment


The executive management of SPECK-PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN
Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik GmbH has to ensure that all
requirements outlined in the Quality Manual are adequately communicated to the employees and
observed during all business activities.
Every employee is obliged to meet the requirements of this Quality Manual and its supplementary
instructions.
Executive staff and employees are obliged to immediately inform the Quality Manager in case of
deviations and, if required, implement corrective actions.
The executive management determines the corporate philosophy, the business objectives, the
planning system and measures as well as short-, medium- and long-term planning targets.

5.2 Customer focus


Our customers' satisfaction determines the success of our company. The way the sales and project
business is conducted by SPECK-PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN
Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik GmbH requires consistent and
intensive personal support of our customers, which automatically results in a strong customer
orientation. Customer satisfaction is continuously monitored by means of statistical evaluations and

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 16 of 33

observations at trainings, trade fairs and sales events. Long-term customer satisfaction and, hence,
customer retention are the objectives of such measures.

5.3 Quality policy


Principles of our quality policy
The quality of our products and services has its seeds in our attitude and the quality of our
thoughts. From this attitude, we derive the following principles:

orientation towards our customers' demands


quality in everything we do
zero-fault-strategy
continuous improvement of all processes
investment in new technologies to increase productivity and effectiveness
innovations through constant questioning of existing solutions
teamwork to accomplish our goals

Quality means to us:

to meet the expectations of our customers in every respect


that products and services comply 100% with the defined requirements
that quality can only be attained by performing all activities with utmost thoroughness and
therefore lies in the area of responsibility of every employee
compliance with legal regulations and directives (e.g. Ex protection)

Quality affects everyone!

Quality is not a matter or hierarchy. Everyone is involved in the quality process - at his/her
level and workplace. No one can be exempted from this responsibility.

Wolfgang Krueger
Managing director
SPECK PUMPEN Walter Speck GmbH & Co. KG and
Speck PUMPEN Systemtechnik GmbH
SPECK PUMPEN Vakuumtechnik GmbH
Version: 25.06.2003

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 17 of 33

5.4 Planning
5.4.1 Quality targets

Quality planning of products and services in operational business of SPECK-PUMPEN Walter Speck
GmbH & Co. KG, SPECK PUMPEN Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik
GmbH is focused on the determined quality targets and accounts for the relevant standards,
regulations and guidelines as well as for customer demands derived from requests.
The specification of tasks and competences for quality planning lies in the area of responsibility of the
executive management.

The following quality targets have been defined:

Customer satisfaction
SPECK PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN Systemtechnik GmbH and
SPECK PUMPEN Vakuumtechnik GmbH would like to convince through top service quality and thus
contribute to the economic success of their customers. Therefore, the primary quality target of
SPECKPUMPEN is to identify the individual needs of customers and develop a solution which
considers the existing framework conditions,
is state-of-the-art in terms of technology,
meets economic and legal constraints
to ensure customer satisfaction in the long run. Long-term support with a comprehensive range of
technical and customer services are included in all our solutions.

Effectiveness of project handling


To ensure flawless commissioning as well as a high and long-term availability of our supplied products
and systems, we place maximum demands on the quality of
conceptual design,
project planning,
handling,
suppliers and
all components

Personnel skills
To help our employees develop excellent skills and motivate them to demonstrate maximum
commitment, to enable them to perform theirs tasks in their own responsibility and in compliance with
the defined targets, SPECKPUMPEN offers
the required means for technical as well as personal training and further education,
important leeway and
the required organisational and material support within the team.
All employees of SPECKPUMPEN are involved in the continuous quality improvement process.

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 18 of 33

Economic stability
The accomplishment of the aforementioned quality targets results in continuously increasing
effectiveness and consequently in economic profitability. This operational strength is vital for the
continued existence of our company and thus for
preserving our jobs,
assuring system support at our customers in the long run and
further increasing quality and competence of SPECKPUMPEN.
To meet these quality targets, SPECKPUMPEN has established a quality management system
according to DIN EN ISO 9001:2008.

Wolfgang Krueger
26.06.2003
Managing director
Speck Pumpen Walter Speck GmbH & Co. KG
Speck PUMPEN Systemtechnik GmbH
Speck PUMPEN Vakuumtechnik GmbH

Applicable documents:
Process instructions Process description
PB 0541

5.4.2 Planning of the QM system


Development, continuous maintenance and revisions of the QM system have been transferred from
the executive management to the Quality Manager and are at least annually assessed by the
executive management within the scope of a management review to ensure the integrity of the QM
system and to implement corrective measures if required.

Applicable documents:
Process instructions Process description
PB 0542

5.5 Responsibility, authority and communication


Responsibilities and authorities of employees with executive functions are defined in the
corresponding job descriptions. The individual departments provide overviews of responsibilities and
authorities of employees.

5.5.1 Management representative


The Head of Quality Assurance holds the title of management representative, whose task is to
maintain and continuously improve the quality management system.

Dipl.- Kfm. (Univ.) T. Hahn


Quality Manager (DGQ)

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 19 of 33

The strategic and operative tasks of this post are as follows:

development of a purposeful system for the control of all products provided by the customer in
cooperation with the responsible divisions
review of the system for compliance with relevant standards according to
DIN EN ISO 9001:2008
maintenance of the system
implementation of CIP ("continuous improvement process")
continuous system review for changing requirements in cooperation with the responsible
divisions
update, maintenance and distribution of all documents referring to quality management
preparation and maintenance of an overview of all corporate documents
issuance, maintenance and distribution of process instructions
distribution of new and updated documents in his area of responsibility,
removal of invalid documents from his division,
quality: issuing of approvals / waivers

5.5.2 Internal communication


Internal communication includes meetings (e.g. weekly production meetings), regular sales and
service meetings and diverse EDP-supported services (Intranet, mailing system, calendar,
scheduling).

5.6 Management review


5.6.1 General
The management review is a review of the QM system by the executive management to guarantee
appropriateness and effectiveness as to compliance with the standard, quality policy and quality
targets.
The executive management reviews at least annually the accomplishment of quality targets and the
effectiveness of the QM system within the scope of a management review and defines new targets
and tasks on the basis of the review results. In case of non-compliance with requirements, corrective
or preventive measures are implemented.

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 20 of 33

5.6.2 Review input


The effectiveness of the quality management system is regularly reviewed and evaluated by the
executive management in cooperation with the Quality Manager on the basis of the following
documents:

results of customer ratings


results of supplier ratings
complaint reports
strategic market analysis (benchmarking)
results of internal quality audits
employee satisfaction analyses
corrective and preventive measures
recommendations for improvement
results of the assessment of the QM system as to processes and procedures for products in
potentially explosive areas

5.6.3 Review output


The integrity of the quality management system, i.e. adequacy and effectiveness concerning the
accomplishment of quality targets, as well as the effectiveness of implemented corrective measures is
evaluated by the executive management before and after major system modifications (management
review).
The management review is based on, e.g. internal audits, which are carried out at least annually for
each division and process.
The management review is based on the following reports and analyses:

audit reports of certification bodies


customer satisfaction reports
internal audit reports
customer complaints
calculations of quality costs
customer visit reports
strategic market and competitor analyses
supplier ratings

The results of the QMS review are documented in the records of the executive management and the
agreed measures for the advancement of the quality management system in accordance with the
continuous improvement approach are regularly edited by the Quality Manager. They are then
forwarded in an adequate manner to the respective divisions for further processing and
communication to the employees.

Applicable documents:
Process instructions Process description
PB 0563

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 21 of 33

6 Resource management

6.1 Provision of resources


The executive management guarantees that sufficient means and resources are planned and provided
for compliance with the quality policy, implementation of quality targets, continuous improvement of
the QM system and attainment of customer satisfaction.
The required means for improving the quality management system and attaining customer satisfaction
are part of annual business planning.

6.2 Human resources


6.2.1 General
The executive management ensures through personal assessment that the assignment of authorities
and responsibilities is based on the professional qualification, skills and experience of personnel. The
heads of the divisions are instructed to regularly inform employees on the introduction or modification
of products, processes and organisational procedures. The Quality Manager holds information events
in the form of trainings or presentations during which he informs on news, expansions and revisions of
the QM system and offers a platform for the exchange of experience with quality-related activities
between the divisions.

6.2.2 Competence, awareness and training


To consolidate and further strengthen the position of our company in the market, we require suitable
employees and executives whose skills and experience are enhanced through continuous training.
An integrated professional training and further education program for a selection of qualified
employees having completed vocational training in the technical or commercial sector has been
introduced to not only strengthen the technical skills but also the quality awareness of our employees.
Particular importance is attached to internal trainings and on-site instructions, which are developed
and held in our company and are especially tailored to the needs of new employees.

Applicable documents:
Process instructions Process description
VA 07 PB 0563
PB 062

6.3 Infrastructure
The executive management has established a corporate infrastructure, which supports and ensures
the production and supply of zero-defect products.
Workplaces and connected facilities have been developed in accordance with economic and quality
requirements in terms of allocation and design.
This also applies to the hardware and software equipment, preventive maintenance and other
supportive services. The required facilities have been provided and are subject to regular inspections
by the trade association or internal maintenance.

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 22 of 33

6.4 Work environment


The personnel and physical factors of the work environment have been considered an important
element in the individual operation sequences on every corporate level.
In addition to compliance with legal health protection and occupational safety regulations, we
constantly strive to improve working methods and general working conditions. Our company
improvement system also considers feedback and suggestions of our employees. We furthermore
comply with all legal regulations on environmental protection.

7 Product realisation
7.1 Planning of product realisation
To guarantee flawless order processing and supply, the tender preparation and order acceptance are
subject to the following guidelines:
The customer is comprehensively informed on the areas of application, cost-efficient realisation of
highly advanced technical equipment, limits of performance.
The requirements stipulated in the contract are checked in terms of compliance with:

conformity with standards


power ratings
durability and warranty
utilisation period.

Prior to conclusion of a delivery contract, submission of a tender or confirmation of an order, we verify


that all customer requirements have been adequately considered and are realisable. This procedure
involves all affected organisational units, whose statements have to be taken into account.

7.2 Customer-related processes (contract review)

Applicable documents:
Process instructions Process description
PB 072
PB 072_1
PB 072_2
PB 072_3
PB 072_4
PB 072_5
PB 072_6

7.2.1 Determination of requirements related to the product


A procedure has been adopted for the close examination of requests, tenders and contracts, which
ensures that

a. customer requirements are fully determined and documented,


b. deviating requirements are clarified before a tender is submitted or an order accepted,
c. feasibility concerning date, technology and legal regulations and directives (e.g. EX protection
directive 94/9/EC) is verified.

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 23 of 33

7.2.2 Review of requirements related to the product


A feasibility analysis is carried out in the sense of a contract review to assess the customer
requirements. Particularly where new developments are concerned, the respective divisions (e.g.
Construction) are involved in the analysis process.

7.3 Design and development


A systematic completion of the development phase has a decisive effect on product quality and
compliance with agreed deadlines and costs.
Special focus has to be given to the planning and control of development activities, the definition of a
design standard and the proper verification of design results.

Applicable documents:
Process instructions Process description
PB 073
VA 09
PB 073_1
VA 10
PB 073_2
VA 14
PB 073_3

7.3.1 Design and development planning


The Engineering Office of SPECK PUMPEN Walter Speck GmbH & Co. KG, SPECK PUMPEN
Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik GmbH controls the development of
new products and processes and transfers quality requirements into product features. Within this
context, customer requests, results of market surveys and production requirements are considered for
development planning.

7.3.2 Design and development inputs


At the stage of the preliminary decision on a development project, all requirements placed upon the
product (design standard) are specified. These specifications have to be complete, clarified and
unambiguous. Sources of design standards may be:

explicit customer specifications (included in the requirements specification)


collected customer requests / proposals
customer demand analysed by the Sales division
product observations, customer complaints
market surveys
information on technologies or research results
analyses of new directives, standards, patents

7.3.3 Design and development outputs


The Engineering Office documents the results of the development work in a way which ensures that
the Production and Assembly divisions are able to manufacture and inspect the product in accordance
with the specifications. At the same time, the quality requirements of our customers have to be met.

7.3.4 Design and development review


The results of our operational development are documented at our in-house laboratory. These records
serve the identification of problems to be able to suggest required measures. The design and
development review is carried out by the Construction division in cooperation with the responsible
other divisions.

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 24 of 33

7.3.5 Design and development verification


The design results are verified at the end of each phase to ensure compliance with the specifications
in accordance with the development plan and process.
The type of verification is defined in the design and development plan. Examples are:

Design and development review


Direct evaluation

Results and measures are documented in a design and development report or test certificate.

7.3.6 Design and development validation


Design and development validation is carried out to verify that the product meets the requirements
addressing the specific intended use. Design and development validation follows a successful design
and development verification of the complete system. This can be done within the scope of
acceptance by the customer.

7.3.7 Control of design and development changes


Design and development changes are treated like new developments. Products which are subject to a
design change pass through the complete development process again.

Applicable documents:
Process instructions Process description
PB 0554
PB 0737

7.4 Purchasing
Applicable documents:
Process instructions Process description
PB 074

7.4.1 Purchasing process


The purchasing process defined by Speck-Pumpen Walter Speck GmbH & Co. KG, Speck
Pumpen Systemtechnik GmbH and SPECK PUMPEN Vakuumtechnik GmbH ensures that all
purchased and deployed products meet the requirements. The Purchasing division identifies the
demand for products and services which have to be purchased from external suppliers on the basis of
the MRP lists of the ERP system. Only the Purchasing division is responsible for purchasing products
and services. Decisions concerning acquisitions of any kind have to be taken by the executive
management.
The Purchasing and the Quality Assurance divisions conduct annual supplier audits to ensure that
strategically important suppliers are able to supply products meeting our requirements. Suppliers who
offer products for potentially explosive areas are subject to an initial audit and an annual supplier audit
according to DIN EN 13980.

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 25 of 33

7.4.2 Purchasing information


All product details are clearly defined in the order text of the individual items to be purchased. The
Purchasing division may cooperate with the corresponding orderer to ensure that all requirements
concerning product and quality are met. All purchasing data are collected and stored by the ERP
system. The sub-supplier receives clear-cut orders containing type designation, order number,
drawing and item number as well as all test specifications to be observed.

7.4.3 Verification of purchased products


Purchased products are inspected by the Incoming Goods department (warehouse dept.) or by the
Explosion Protection Officer when products for Ex areas are delivered. The required inspections are
listed in general or specific inspection plans. Newly purchased products entering the production
process are subject to an initial sample inspection. In case the sub-suppliers of products to be
purchased are exchanged, the supplied products are examined within the scope of initial sample
inspections to ensure the supplier is able to meet our requirements.

Applicable documents:
Process instructions Process description
PB 074_1
PB 074_3
PB 074_4
PB 074_5
PB 074_6
PB 074_7

7.5 Production and service provision


Applicable documents:
Process instructions Process description
PB 075
PB 075_1

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 26 of 33

7.5.1 Control of production and service provision


All procedures in the production and assembly areas are strictly categorised according to their
individual production and inspection stages. The individual workplaces in the production area are
equipped with work instructions and special inspection plans containing clear-cut instructions.
Order-specific parameters are listed in the process-accompanying documents.

The process-accompanying documents usually include

construction drawings with all data relevant to the production process


production orders with route card, tool parameters and, where required, inspection plans.

The individual production stages including inspections are specified.


All production and inspection steps during the production process are recorded on the route card
accompanying production and simultaneously registered by the PDA system.
The monitoring of the process parameters as well as the performance of product tests fall within the
scope of self-tests subject to specified inspection plans.
Production equipment is monitored on the basis of deviation analyses and error logs. Regular
preventive maintenance of all production equipment prevents unexpected process interruptions.

Clear-cut instructions in the form of work instructions, inspection plans and accompanying documents
have been defined for the individual assembly areas. Appropriate workplaces featuring an elaborate
design ensure that all works are performed according to our quality standards.
Quality control is guaranteed through incoming goods and continuous intermediary inspection and the
respective documentation.

Applicable documents:
Process instructions Process description
PB 0751

7.5.2 Validation of processes for production and service provision


The individual steps of our production processes are reviewed and finished products evaluated
through post-calculation. The services accompanying the products are also subject to assessment
through customer satisfaction analyses. A process flow chart describes the exact procedures to be
followed.

Applicable documents:
Process instructions Process description
PB 0752

7.5.3 Identification and traceability


To be able to identify documents and products, unique systematic codes are used. These codes
ensure that products, processes and documents can be clearly assigned.
All production documents are identified by unique assembly order numbers.
Products or spare parts are usually identified by production-accompanying technical documents (route
card).

The inspection status of the products is recorded in the road maps and clearly identifiable at any time.
This guarantees that only tested products meeting all requirements are further processed or supplied
to the customer.

Applicable documents:
Process instructions Process description
QM according to DIN EN ISO 9001: 2008
Revision S

Quality Manual 03.11.2015


Page 27 of 33

VA 16 PB 0753

7.5.4 Customer property


Parts or materials provided by the customer for further processing are treated in accordance with the
same guidelines as products purchased by our company.
All goods arriving at the Incoming Goods department (warehouse dept.) are checked for completeness
and flawlessness.
If, despite most careful handling, the customer's property is accidentally damaged or made unusable
in any other way, the executive management informs the customer immediately to agree on further
steps.
Particularly customer requests - this also refers to secrecy regarding intellectual property - can be
specified in individual contracts. If required, such requests are translated into internal instructions.

Applicable documents:
Process instructions Process description
PB 0754_1

7.5.5 Preservation of product


Suitable storage areas are available for raw materials, semi-finished and finished goods. The goods
and materials are stored in a way which prevents deterioration of quality or damages and guarantees
identifiability.
Only when all tests have been successfully completed and the corresponding documentation is
available and authorised are the products prepared for storage or shipping.
Non-compliant products and materials are identified accordingly. The respective label is only removed
after further processing has been approved.
Instructed personnel who is familiar with conventional standards is responsible for product storage,
packaging and shipping as well as for checking the applicability of the means of transport.
All transport and lifting devices are regularly inspected by a competent service provider and marked
with an inspection label.
Individual customer requests for special packaging or preservation are documented in the production
documents.

Applicable documents:
Process instructions Process description
VA 12 PB 0755
PB 0755_1
PB 0755_2
PB 0755_3

7.5.6 Export control & customs expert (ECCE)

The ECCE ensures observance of export regulations throughout the company. The ECCE verifies
compliance of exports with customs rules and foreign trade legislation in day-to-day business and
organises the implementation of respective measures. The ECCE is the contact person for authorities
(customs, export customs office and customs office of exit, Federal Office of Economics and Export
Control, ministries) and service providers (e.g. forwarding agents). Export control at SPECK PUMPEN
is handled by the persons responsible for exports (Head of Sales) and export controls and the
technical evaluation team (Head of Engineering)

Export manager
Ms Maria Beringer

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 28 of 33

7.6 Control of monitoring and measuring devices


Selection of the testing equipment depends on the parameters to be monitored, the measuring
method, the measuring range and the measuring accuracy. This is why we determine the parameter to
be measured as well as suitable testing equipment for every product separately.
Testing equipment used to ensure compliance with quality requirements is subject to testing
equipment monitoring and calibration.
Such testing equipment is marked with a unique identification code.
Calibration scope, intervals and calibration laboratory are determined for every testing device.
Calibration is carried out on the basis of certified measurement standards. The calibration results are
documented in the "Calvin" software product.
Testing equipment which is not used to verify compliance with the required product characteristics is
not subject to testing equipment monitoring and not labelled.
All employees have been instructed to use only testing equipment marked with an identification code
for quality tests. Archiving, classification, identification and monitoring of testing and measuring
equipment lie in the area of responsibility of Quality Assurance.

Applicable documents:
Process instructions Process description
PB 076
PB 076_1
PB 076_2
PB 076_3

8 Measurement, analysis and improvement

8.1 General
The executive management specified in cooperation with the heads of the individual divisions methods
and equipment for planning, analysis and improvement.

8.2 Monitoring and measuring


Applicable documents:
Process instructions Process description
PB 082

8.2.1 Customer satisfaction

8.2.1.1 Maintenance and customer service

Customer complaints are handled quickly within the scope of a special complaint procedure. Fast
provision of support to the customer takes priority.
A process flow chart represents all responsibilities in a way which ensures that all product complaints
and repairs are accurately recorded and processed.
Quality Assurance evaluates damage reports and customer complaints in cooperation with Service in
accordance with the CIP. The Quality Manager is responsible for the implementation of improvement
measures and their monitoring for effectiveness.

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 29 of 33

Applicable documents:
Process instructions Process description
PB 072_6

8.2.1.2 Monitoring of customer satisfaction

Customer satisfaction is determined in regular intervals. For this purpose, supplier ratings, turnover
developments, complaint statistics and personal customer visits are analysed.

Applicable documents:
Process instructions Process description
PB 072_5

8.2.2 Internal audit


One of the most efficient measures for evaluating the effectiveness of our quality management system
is the implementation of internal quality audits. Internal audits help to identify weaknesses and
ambiguities to provide for a continuous improvement of the QM system.
The relevant standards of DIN EN ISO 9000 et seq. and DIN EN 13980, the Quality Manual,
documented procedures, work instructions and other quality-related documents and records form the
basis of these audits.
The Quality Manager drafts an annual audit schedule, which covers all organisational units. The audits
are performed by the Quality Manager or another authorised person.
Any deviations detected during audits are recorded in an audit report in writing.
Corrective measures are agreed upon with the respective person in charge if required. The
implementation of the corrective measures will then be evaluated within the scope of follow-up audits.
In addition to scheduled audits also unscheduled audits may be carried out if required by substantial
procedural changes or by identified or supposed deviations.
The results of internal audits lay the groundwork for the executive management's evaluation of the
quality management system and the identification of improvement potential.

Applicable documents:
Process instructions Process description
VA 03

8.2.3 Monitoring and measuring of processes


Monitoring and measuring of processes is specified in the process descriptions and - where applicable
or required - measurable and controllable by means of key process data.
In the field of production, PDA data inform on the progress of individual operating sequences and the
scheduling of the entire production order.

Applicable documents:
Process instructions Process description
PB 0823

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 30 of 33

8.2.4 Monitoring and measuring of the product


Despite thorough production, which excludes faults to the greatest possible extent, product tests are
inevitable. Such tests make sure that our customers get a product which precisely meets the required
specifications.
Targeted checks during and after completion of the production process ensure that faults are detected
in due time.

Applicable documents:
Process instructions Process description
PB 0824

8.2.4.1 Testing schedule

The characteristics to be tested are listed on the product-accompanying drawings or road maps. If
required, the testing equipment to be used as well as the scope of measuring is specified in the work
instructions. If the customer requests special features and characteristics as proof, these are already
considered at the time of order acceptance.

8.2.4.2 Incoming goods inspection

Every consignment is checked for completeness, timeliness, damage, identification and appropriate
packaging. The same applies to the shipping documents.
The inspection results are documented in the shipping documents. Incoming goods inspections for Ex
products are separately inspected by the Explosion Protection Officer / deputy.

Applicable documents:
Process instructions Process description
PB 0824_1
PB 0824_5

8.2.4.3 In-process inspection (self-monitoring)

All relevant dimensions are checked at scheduled intervals during the entire production process. The
measurements are carried out as a means of self-monitoring (operator self-check) by qualified
personnel.

Applicable documents:
Process instructions Process description
PB 0824_2

8.2.4.4 Final inspection

A product is considered finished as soon as it meets all defined and required specifications. If
requested, all necessary tests are documented. The product is ready for shipment as soon as it has
been marked with a pump number. All pumps are subject to a comprehensive final inspection.

Applicable documents:
Process instructions Process description
PB 0824_3

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 31 of 33

8.3 Control of non-conforming products


All employees are obliged to immediately report faults which are detected during the incoming goods
inspection or processing. Such non-conforming products are identified to prevent accidental further
processing. The process description contains instructions as to the treatment of faults. A documented
procedure regulates

identification of non-conforming elements


calculation of reworking costs and identification of the cause of fault
notification of the responsible bodies of the occurred faults,
treatment of non-conforming intermediate or finished products as well as reworks
special release, alternative use or disposal.

Applicable documents:
Process instructions Process description
VA 04 PB 083
PB 083_1
PB 083_2
PB 083_3
PB 083_4

8.4 Data analysis


The evaluation of our management system is based on the following data:

applicability of the quality management system through regular internal audits


turnover development
evaluation of warranty costs compared to turnover
evaluation of customer satisfaction through personal customer visits, repurchase rate of bulk
customers and customer ratings
evaluation of reworking and non-conformity costs in production and assembly
supplier ratings
employee satisfaction on the basis of labour turnover and status of employee's illness as well
as appraisal interviews

8.5 Improvement
8.5.1 Continuous improvement
The "continuous improvement process" (CIP) is integrated in the processes of the company. Analyses
of (statistical) evaluations and the implementation of measures resulting thereof guarantee continuous
process optimisation.

8.5.2 Corrective action


All faults in the product or QM system as well as all production or assembly faults are systematically
analysed. In case of any events impairing quality during order planning, purchasing, production and
inspection, respective measures are implemented to prevent reoccurrence of faults and failures. The
effectiveness of corrective action is monitored. If necessary, the implemented measures are revised.

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 32 of 33

A documented procedure regulates

fault evaluation of customer complaints,


fault analysis (causal research),
identification and implementation of required measures,
documentation of results,
and the evaluation of the corrective measures taken.

Applicable documents:
Process instructions Process description
VA 05 PB 0541

8.5.3 Preventive action


In order to avoid the reoccurrence of faults in the future, precise fault analyses are carried out to
identify the cause of the fault and preventive measures are taken. Customer feedbacks, quality
deviations detected within the scope of routine checks as well as audit results are incorporated in
preventive action planning. The effectiveness of preventive action is monitored. If necessary, the
implemented measures are revised. All modifications are specified in new documents (work
instructions, drawings) and the updated documents are issued.

Preventive action involves:

Utilisation of FMEAs for new product designs (if requested by the customer or considered
necessary)
experience gained from corrective action
experience gained from previous projects and developments
drafting of contracts concerning schedule and product requirements of parts from suppliers
clarification of production and inspection process
internal audits for process evaluation
training measures
preventive maintenance of machine and other production means

Applicable documents:
Process instructions Process description
VA 06 PB 0542

QM according to DIN EN ISO 9001: 2008


Revision S

Quality Manual 03.11.2015


Page 33 of 33

Current revision status


Modifications Revision Date
New issue according to DIN ISO 9001/2000 A 02.01.2003
Explosion protection added B 25.06.2003
Re-naming of SPECK-PUMPENFABRIK Walter Speck GmbH & Co. KG
C 02.01.2004
into Speck Pumpen Walter Speck GmbH & Co. KG
Revision of the organisation plan, paragraph 5.5.1.3.4 added, Applicable documents "PB 074_2" under
paragraph 7.4.3 deleted, Applicable documents "PB 075_2" under paragraph 7.5.1 deleted, correction D 19.04.2005
of spelling and grammar mistakes
Correction of the number of employees paragraph 3.1
Modification of the organisation plan - paragraph 3.2
List of duties of executive management deleted paragraph 5.1 E 20.01.2006
Complete revision of responsibilities and authorities paragraph 5.5
Correction of spelling and grammar mistakes
Correction of the number of employees paragraph 3.1
Modification of the organisation plan - paragraph 3.2 F 21.12.2006
Correction of spelling and grammar mistakes
Modification of the organisation plan - paragraph 3.3 G 13.08.2007
Modification of the organisation plan - paragraph 3.3 H 24.09.2007
Adjustment to DIN EN ISO 9001:2008 and DIN EN ISO 9004:2008
SPECK PUMPEN Vakuumtechnik GmbH added as company
Modification of the company's history - paragraph 3.1
I 16.01.2009
Modification of the organisation plan - paragraph 3.3
Paragraph 5.5.2 KBA manager deleted
Change of company logo
Modification of the organisation plan - paragraph 3.3 J 22.09.2009
Modification of the organisation plan - paragraph 3.3
K 08.06.2010
Export control added paragraph 7.5.6
Modification of the organisation plan - paragraph 3.3 L 23.02.2011
Modification of the organisation plan - paragraph 3.3 M 31.10.2011
Modification of the organisation plan - paragraph 3.3 N 26.09.2012
Modification of the organisation plan - paragraph 3.2
Expanded powers of the QM Manager O 15.01.2013

Modification of the organisation plan - paragraph 3.2 P 17.02.2014


Modification of the organisation plan - paragraph 3.2 Q 17.11.2014
Paragraph 4.2.2.1 elimination of errors
Paragraph 4.2.4.2.1 elimination of errors
Paragraph 5.5.2 PB0553 removed
R 08.01.2015
Paragraph 6.4 PB07 removed
Paragraph 8.2.1.1 PB0821 removed 1st set deleted
Paragraph 8.2.1.2 PB0821 removed
Modification of the organisation plan - paragraph 3.2 S 03.11.2015

QM according to DIN EN ISO 9001: 2008

You might also like