Document Control System in Manufacturing Industry

Document Control System In Manufacturing Industry

Many traditional paper documents would be generated in a manufacturing business as in the examples listed below:

• Statutory documents such as licenses, records and reports
• Transactional documents such as purchase and sales invoices, shipping documents and cash vouchers
• Production related documents such as operations manuals, specification sheets, production and maintenance schedules, machine production reports, material handling documents, store bin cards and gate passes

• Management reports where the recipient prefer printed paper documents to computer screen views
• Business documents such as correspondence, contracts, brochures and reference materials

However, in a modern system, the majority of documents would be generated as computer documents, and remain as such. Different kinds of databases like financial accounts, inventory records and different kinds of analyses are examples. The core functions outlined in the previous section would each produce a continuing flow of voluminous documents.

In addition to providing management information, document management systems also do the following:

• Ensure that only authorized persons are able to access sensitive documents
• Minimize the danger of damage and loss of important documents

• Preserve the documents as long as needed by statute or for management purposes

Records Required by ISO 9001 Standard

Records Required by ISO 9001 Standard
ISO 9000 requires that records be kept of critical operations. Record keeping is the fourth tier of required documentation in ISO 9000, following the Quality Policy Manual, Procedures, and Work Instructions.
Questions you may have include:
•What is a record?
•What are the required records?
•What is the reason for these records?
This lesson will answer those questions. There is a mini-quiz near the end of the lesson.
What is a record?
Records consist of any historical documentation, such as summaries or meetings and reviews, specifications, invoices, results of tests and such. This is different than procedures and instructions that tell what do to. Instead, a record is the history of what has been done.
Records required
The following lists the records required under ISO 9001 version 2000, along with the referring sub-paragraph number from the standard. ISO 9002 and ISO 9003 would be subsets of this list. Of course, a company may choose to include additional records that they deem important.
Para.
Record Required
5.6.1
Management reviews
6.2.2 (e)
Education, training, skills and experience
7.1 (d)
Evidence that the realization processes and resulting product fulfill requirements
7.2.2
Results of the review of the requirements relating to the product and actions arising from the review
7.3.2
Design and development inputs
7.3.4
Results of design and development reviews and any necessary action
7.3.5
Results of design and development verification and any necessary action
7.3.6
Results of design and development validation and any necessary action
7.3.7
Results of the review of design and development changes and any necessary action
7.4.1
Results of supplier evaluations and actions arising from evaluations
7.5.2 (d)
As required by the organization to demonstrate the validation of processes where subsequent monitoring and measurement cannot verify the resulting output
7.5.3
Unique identification of the product, where traceability is a requirement
7.5.4
Customer property that is lost, damaged, or otherwise found to be unsuitable for use
7.6 (a)
Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6
Validity of previous results when measuring equipment is found not to conform to its requirements
7.6
Results of calibration or verification of measuring equipment
8.2.2
Internal audit results
8.2.4
Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product
8.3
Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2
Results of corrective actions
8.5.3
Results of preventive actions
Reason for records
The reason to keep records is for future use as a reference in case of questions related to contractual and legal matters, work techniques, verification of work done, and other parts essential to the company running smoothly. The company management should use sound judgment as to what records are non-essential and how long to keep a specific record.

Records Required by ISO 9001 Standard

Records Required by ISO 9001 Standard
ISO 9000 requires that records be kept of critical operations. Record keeping is the fourth tier of required documentation in ISO 9000, following the Quality Policy Manual, Procedures, and Work Instructions.
Questions you may have include:
•What is a record?
•What are the required records?
•What is the reason for these records?
This lesson will answer those questions. There is a mini-quiz near the end of the lesson.
What is a record?
Records consist of any historical documentation, such as summaries or meetings and reviews, specifications, invoices, results of tests and such. This is different than procedures and instructions that tell what do to. Instead, a record is the history of what has been done.
Records required
The following lists the records required under ISO 9001 version 2000, along with the referring sub-paragraph number from the standard. ISO 9002 and ISO 9003 would be subsets of this list. Of course, a company may choose to include additional records that they deem important.
Para.
Record Required
5.6.1
Management reviews
6.2.2 (e)
Education, training, skills and experience
7.1 (d)
Evidence that the realization processes and resulting product fulfill requirements
7.2.2
Results of the review of the requirements relating to the product and actions arising from the review
7.3.2
Design and development inputs
7.3.4
Results of design and development reviews and any necessary action
7.3.5
Results of design and development verification and any necessary action
7.3.6
Results of design and development validation and any necessary action
7.3.7
Results of the review of design and development changes and any necessary action
7.4.1
Results of supplier evaluations and actions arising from evaluations
7.5.2 (d)
As required by the organization to demonstrate the validation of processes where subsequent monitoring and measurement cannot verify the resulting output
7.5.3
Unique identification of the product, where traceability is a requirement
7.5.4
Customer property that is lost, damaged, or otherwise found to be unsuitable for use
7.6 (a)
Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6
Validity of previous results when measuring equipment is found not to conform to its requirements
7.6
Results of calibration or verification of measuring equipment
8.2.2
Internal audit results
8.2.4
Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product
8.3
Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2
Results of corrective actions
8.5.3
Results of preventive actions
Reason for records
The reason to keep records is for future use as a reference in case of questions related to contractual and legal matters, work techniques, verification of work done, and other parts essential to the company running smoothly. The company management should use sound judgment as to what records are non-essential and how long to keep a specific record.

ISO 9000 Document Control Procedures

ISO 9000 Standards Document control procedures
The ISO 9000 Standards requires that a documented procedure be established to define the controls needed.

This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.

Although the ISO 9000 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.

Different Between Quality Assurance & Quality Control

QA: Quality Assurance is the process which are having their eyes on the process to provide the assurity of the quality. like doing the testing at the time of development, giving the review comments and forced the developers to fixed the defects of the requirement, designed, coding and testing phase is the Quality Assurance.

Quality Control: Before delivering the product to make sure that all the documentation are provided, product has meet with the requirement criteria, all the SDLC phase are met with the exit criteria is the Quality control.

Difference between Quality Control and Quality Assurance? Quality Control Quality Assurance Definition QC is about checking at the end of some development process (e.g. – a design activity) that we have built quality in i.e. that we have achieved the required quality with our methods. QA is about having an overall development and management process that provides right environment for ensuring quality of final product. Description QC is like testing a module against requirement specification or design document, measuring response time, throughput etc. QA gives us added assurance that the whole producing or checking process is properly planned and executed and thus maintaining high quality. What it does To check that the modern methods of software development are largely designed to ensure right quality is achieved. QC checks that these methods are in place and to discover where they are not then corrections are to be made. It gives us added assurance that the while producing / checking process is being properly planned and executed and hence is keeping high our chances of producing software of required quality. Stages Define features and levels Define feature check procedure Carrying out the check procedure Record the result take and record any corrective action taken. 1. Determination of quality policy through Quality Management System 2. Checking that predetermined Quality control activities are being properly taken care off. Best carried out on QC is best carried out on products QA is best carried out on process. Phase of implementation QC should take place at every stage of SDLC. QA should be done at end of every SDLC i.e. when product building is complete. Technique Structured walkthrough, Fagan Techniques are some of QC techniques. Quality policy defined and generally implemented in the form of Quality Management System is used to carry out QA.

As per ISO 9000 Standards:

Quality Control means – The Operational Techique and activities that are used to fullfill requirements of Quality,

Quality Assurance means – All Those planned and systematic activites implemented already , to provide adequate confidence that an entity will fulfillrequirements of Quality.

The following table can explain in detail:

QC QA

Product Process

Reactive Pro-active

Line Function Staff Function

Find the defects Prevent the defects

e.g.

QC QA

Walkthrough Quality Audit

Testing Defining Process

Inspection Selection of tools

Checkpoint Review Trainings

Different Between Quality Assurance & Quality Control

QA: Quality Assurance is the process which are having their eyes on the process to provide the assurity of the quality. like doing the testing at the time of development, giving the review comments and forced the developers to fixed the defects of the requirement, designed, coding and testing phase is the Quality Assurance.

Quality Control: Before delivering the product to make sure that all the documentation are provided, product has meet with the requirement criteria, all the SDLC phase are met with the exit criteria is the Quality control.

Difference between Quality Control and Quality Assurance? Quality Control Quality Assurance Definition QC is about checking at the end of some development process (e.g. – a design activity) that we have built quality in i.e. that we have achieved the required quality with our methods. QA is about having an overall development and management process that provides right environment for ensuring quality of final product. Description QC is like testing a module against requirement specification or design document, measuring response time, throughput etc. QA gives us added assurance that the whole producing or checking process is properly planned and executed and thus maintaining high quality. What it does To check that the modern methods of software development are largely designed to ensure right quality is achieved. QC checks that these methods are in place and to discover where they are not then corrections are to be made. It gives us added assurance that the while producing / checking process is being properly planned and executed and hence is keeping high our chances of producing software of required quality. Stages Define features and levels Define feature check procedure Carrying out the check procedure Record the result take and record any corrective action taken. 1. Determination of quality policy through Quality Management System 2. Checking that predetermined Quality control activities are being properly taken care off. Best carried out on QC is best carried out on products QA is best carried out on process. Phase of implementation QC should take place at every stage of SDLC. QA should be done at end of every SDLC i.e. when product building is complete. Technique Structured walkthrough, Fagan Techniques are some of QC techniques. Quality policy defined and generally implemented in the form of Quality Management System is used to carry out QA.

As per ISO 9000 Standards:

Quality Control means – The Operational Techique and activities that are used to fullfill requirements of Quality,

Quality Assurance means – All Those planned and systematic activites implemented already , to provide adequate confidence that an entity will fulfillrequirements of Quality.

The following table can explain in detail:

QC QA

Product Process

Reactive Pro-active

Line Function Staff Function

Find the defects Prevent the defects

e.g.

QC QA

Walkthrough Quality Audit

Testing Defining Process

Inspection Selection of tools

Checkpoint Review Trainings

Advantages Of ISO 9001 Standard

Successful firms are good at two things: increasing sales and reducing costs. However, these two things may prove irrelevant if the quality of the product or service is poor. ISO 9001 Standard is concerned with improving the quality of operations which can affect both top and and bottom line growth. Implementation of ISO 9001 Standard affects the entire organization by providing a transition to both a new common language and a new way of thinking about continuous process improvement. Here’s how you can bring the benefits of ISO 9001 Standard to your organization.

1. Obtain management buy-in. The most important step to any quality initiative is to obtain management commitment. This will increase both the visibility and awareness of your efforts.

2. Create an implementation team. This should include a representative from all functional areas of the organization including marketing, finance, planning, production and design. Also be sure to assign a Management Representative. This should be your strongest upper-level advocate for the success of ISO 9001 Standard implementation.

3. Communicate the goals of the program and provide training. This should include employees as well as major suppliers. The communication should be concise, tied to improving the success of current goals and objectives, and in a language in which employees are familiar with.

4. Map out the most critical processes of the current system. Use an organizational flow chart to show how information flows from the placement of an order to delivery. Compare this flowchart with the ISO 9001 system (see Resources for a link to Management Standards) and identify areas for improvement.

5. Create an implementation plan based on opportunities for improvement found in Step 4. The plan should be thorough and specific. Document each change in the process flowchart. If you already have documentation supporting your processes, use it. However, if you identify an area which lacks documentation, this should be viewed as an opportunity. Documentation is the lifeblood of continuous improvement. If you don’t already have one, create a documentation control system which manages the creation, approval, distribution, storage and disposal of documents.

6. Report out on improvements, create metrics to track improvements and repeat the process. ISO 9001 Standard is about continuous process improvements, and the success of the program is a function of both commitment and the achievement of this goal.

Advantages Of ISO 9001 Standard

Successful firms are good at two things: increasing sales and reducing costs. However, these two things may prove irrelevant if the quality of the product or service is poor. ISO 9001 Standard is concerned with improving the quality of operations which can affect both top and and bottom line growth. Implementation of ISO 9001 Standard affects the entire organization by providing a transition to both a new common language and a new way of thinking about continuous process improvement. Here’s how you can bring the benefits of ISO 9001 Standard to your organization.

1. Obtain management buy-in. The most important step to any quality initiative is to obtain management commitment. This will increase both the visibility and awareness of your efforts.

2. Create an implementation team. This should include a representative from all functional areas of the organization including marketing, finance, planning, production and design. Also be sure to assign a Management Representative. This should be your strongest upper-level advocate for the success of ISO 9001 Standard implementation.

3. Communicate the goals of the program and provide training. This should include employees as well as major suppliers. The communication should be concise, tied to improving the success of current goals and objectives, and in a language in which employees are familiar with.

4. Map out the most critical processes of the current system. Use an organizational flow chart to show how information flows from the placement of an order to delivery. Compare this flowchart with the ISO 9001 system (see Resources for a link to Management Standards) and identify areas for improvement.

5. Create an implementation plan based on opportunities for improvement found in Step 4. The plan should be thorough and specific. Document each change in the process flowchart. If you already have documentation supporting your processes, use it. However, if you identify an area which lacks documentation, this should be viewed as an opportunity. Documentation is the lifeblood of continuous improvement. If you don’t already have one, create a documentation control system which manages the creation, approval, distribution, storage and disposal of documents.

6. Report out on improvements, create metrics to track improvements and repeat the process. ISO 9001 Standard is about continuous process improvements, and the success of the program is a function of both commitment and the achievement of this goal.

ISO 9001 Standards Certification

ISO 9001 Standards Certification

When an organization chooses not to pursue ISO 9001 certification or not to retain the ISO 9001 certificate, it should make no difference to the way the organization is managed. It’s similar to the man who chooses not to take the course examination. He still has the knowledge he has acquired whether or not he takes the exam and gets a certificate. What he cannot do is demonstrate to others that he has reached a certain level of education without having to prove it every time. People who know him don’t care that he didn’t take the exam. It is only those who don’t know him that he will have difficulty convincing.

KEY CONSIDERATIONS IN IMPLEMENTING ISO 9001 IN SMEs

There are many issues that must be addressed in moving the QMS from the initial state to the desired state. For example, all organizations implementing ISO 9001 will need to consider the unique culture within the organization, its size, and the resources available. Beyond those widely discussed points, three issues that merit particular attention are (1) consideration of the QMS as a parallel function, (2) training, and (3) auditing. Key points associated with these issues are discussed below.

In the case of all of the transitions depicted, real benefits from the QMS are more

likely to be experienced if the QMS is implemented directly into the core structure of the organization. SMEs must be cautious against establishing a QMS that is run separately in parallel to its other systems. In SMEs, the parallel subsystem most commonly exhibits itself as a separate Quality Assurance, or in some cases, ISO 9001 department. Possible reasons for this may include the existence of rigid departmental boundaries in some SMEs or overemphasis on core activities. As Yauch and Steudel [10] note, SMEs tend to focus their attention on “…necessary routine activities (such as sales, production, shipping, etc.) rather than activities aimed at improving processes or systems.” If a SME insists on establishing a separate quality department, its level of effectiveness can be increased by embedding the QMS in widely-used organizational systems where practical. The integration is largely a function of how well the QMS manages to share information with other subsystems and its ability to align with the policies, norms, goals, and values in place throughout the organization.

In SMEs, training and staff development is more likely to be ad hoc and small scale because of modest human and financial resources and the absence of a specific training budget. To prevent the problems arising from lack of education and training, two things must be done:

1. Education of Top Management: The centralization of decision-making processes within many SMEs means that the management can either be the main stumbling block to change or the main catalyst for change. Therefore, any approach to ISO 9001 implementation must involve considerable education for the top management of the organization to create awareness and understanding of the implementation process as a change initiative. Implementing a fully functional and documented QMS requires motivation by top management to appreciate, achieve, and implement the necessary measures to meet the standards’ criteria.

2. Education and Training of Employees: SMEs are often under pressure to quickly gain ISO 9001 registration. Meeting the requirements of the standard in a short period of time can prove a formidable obstacle for a small company. Since most SMEs do not possess the needed expertise internally, they may be inclined to hire external experts to provide the necessary technical expertise and manpower. However, having a functioning and documented QMS requires more than that. It requires ensuring that all employees in the organization clearly know what is expected of them and how they can contribute to the attainment of their organizations’ goals. This will likely require the preparation and implementation of a training plan tailored specifically to the unique characteristics and maturity level of the SME.

As emphasized throughout the paper, a QMS is not going to produce the expected results unless it is fully functional. While auditing must therefore verify the existence of the necessary documentation, it must also focus on the functionality of the QMS. The measurement of the functionality and the qualitative and financial impacts of a QMS have been the subject of several studies, including Kaynak. Among the categories used to measure functionality and performance improvement, two are particularly noteworthy for our purposes: management commitment and employee involvement. A QMS cannot be functional in the absence of those two characteristics. Therefore, as a minimum, internal and external auditors should continually verify top management’s commitment to increased company-wide quality awareness and improvement in addition to employee involvement in the design, implementation, operation, and improvement of quality related processes and procedures.

KEY CONSIDERATIONS IN IMPLEMENTING ISO 9001 IN SMEs

There are many issues that must be addressed in moving the QMS from the initial state to the desired state. For example, all organizations implementing ISO 9001 will need to consider the unique culture within the organization, its size, and the resources available. Beyond those widely discussed points, three issues that merit particular attention are (1) consideration of the QMS as a parallel function, (2) training, and (3) auditing. Key points associated with these issues are discussed below.

In the case of all of the transitions depicted, real benefits from the QMS are more

likely to be experienced if the QMS is implemented directly into the core structure of the organization. SMEs must be cautious against establishing a QMS that is run separately in parallel to its other systems. In SMEs, the parallel subsystem most commonly exhibits itself as a separate Quality Assurance, or in some cases, ISO 9001 department. Possible reasons for this may include the existence of rigid departmental boundaries in some SMEs or overemphasis on core activities. As Yauch and Steudel [10] note, SMEs tend to focus their attention on “…necessary routine activities (such as sales, production, shipping, etc.) rather than activities aimed at improving processes or systems.” If a SME insists on establishing a separate quality department, its level of effectiveness can be increased by embedding the QMS in widely-used organizational systems where practical. The integration is largely a function of how well the QMS manages to share information with other subsystems and its ability to align with the policies, norms, goals, and values in place throughout the organization.

In SMEs, training and staff development is more likely to be ad hoc and small scale because of modest human and financial resources and the absence of a specific training budget. To prevent the problems arising from lack of education and training, two things must be done:

1. Education of Top Management: The centralization of decision-making processes within many SMEs means that the management can either be the main stumbling block to change or the main catalyst for change. Therefore, any approach to ISO 9001 implementation must involve considerable education for the top management of the organization to create awareness and understanding of the implementation process as a change initiative. Implementing a fully functional and documented QMS requires motivation by top management to appreciate, achieve, and implement the necessary measures to meet the standards’ criteria.

2. Education and Training of Employees: SMEs are often under pressure to quickly gain ISO 9001 registration. Meeting the requirements of the standard in a short period of time can prove a formidable obstacle for a small company. Since most SMEs do not possess the needed expertise internally, they may be inclined to hire external experts to provide the necessary technical expertise and manpower. However, having a functioning and documented QMS requires more than that. It requires ensuring that all employees in the organization clearly know what is expected of them and how they can contribute to the attainment of their organizations’ goals. This will likely require the preparation and implementation of a training plan tailored specifically to the unique characteristics and maturity level of the SME.

As emphasized throughout the paper, a QMS is not going to produce the expected results unless it is fully functional. While auditing must therefore verify the existence of the necessary documentation, it must also focus on the functionality of the QMS. The measurement of the functionality and the qualitative and financial impacts of a QMS have been the subject of several studies, including Kaynak. Among the categories used to measure functionality and performance improvement, two are particularly noteworthy for our purposes: management commitment and employee involvement. A QMS cannot be functional in the absence of those two characteristics. Therefore, as a minimum, internal and external auditors should continually verify top management’s commitment to increased company-wide quality awareness and improvement in addition to employee involvement in the design, implementation, operation, and improvement of quality related processes and procedures.