ISO 9000 Standards – Design and development

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

ISO 14001 Standards Audit

ISO 14001:2004 emphasizes the continuous improvement of an environmental management system (EMS). The standard specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and information about significant environmental aspects. The certification process ensures the conformance of your EMS against the international standard, as well as any organizational specific requirements that have been identified.

The ISO 14001 Standards audit consist of 2 stage registration audit process followed by surveillanceaudits, and ultimately a recertification audit. ISO 14001 Audits include on-site assessments of documents, data, records, activity and personnel. Process audit trails are followed by interviews of personnel responsible for the tasks and reviewing associated activity and records of occurrence. The audit trail will follow interactions between processes as well as the details of the process itself. Following are the stages of the audit process.

Pre-assessmentRegistration Audit – Stage 2Audit Findings• A review of action taken on nonconformities identified during the previous audit• A review of the continued effectiveness of the management system in its entiretyThe continued applicability to the scope of registration

The pre-assessment audit is an optional activity, outside of the registration process, it is highly encourages that any organization to undertake to evaluate the readiness to undergo the two stage registration process. That would optimally occur prior to the stage 1 and 2 audits.

Unlike the Stage 1 and Stage 2 activities you have full discretion as to which areas the preassessment should focus on and for the length of the pre-assessment. This activity allows your organization to become familiar with the audit process and helps prepare your employees for the registration assessment.

The auditor conducting the pre-assessment will typically return to the organization for the assessment. Similar to a ‘true’ audit, the end result of the pre-assessment will be a documented report identifying findings observed during the audit and a closing meeting to discuss the issues.

The pre-assessment activity allows you to correct any issues prior to beginning the registration process.

Assessment

New requirements for certification bodies have changed the registration process. Registration is now conducted in two distinct visits- Stage One and Stage Two- each of which has defined requirements that are outlined below.

Registration Audit – Stage 1

The stage 1 audit, conducted at your facility, is primarily performed for planning and determining the readiness of an organization to undergo a stage 2 registration audit. It also facilitates communicating any needs and expectations to the organization. Activities performed at a stage 1 audit include:

• Conducting a documentation review – This review determines if the organization’s EMS documentation adequately covers all the requirements of the ISO standard

• A review of the aspects and impacts and their significance and an evaluation of the facility(s) site specific conditions

• A review of your organizations non-conformance, preventive and corrective action system • An overview of applicable regulations

• Interviewing your organization’s personnel to assess their general readiness to undertake a stage 2 audit

• Confirming the applicability of the scope of the organization’s EMS

• Obtaining evidence that internal audits and management reviews are being planned and performed

• Providing focus for the planning of the stage 2 audit

If during the stage 1 audit any nonconformities are identified, the auditor will request a corrective action response (see Corrective Action Response).

The objective of the Stage 2 on-site audit is to assess your organizations’ adherence to your own policies, objectives, and procedures and to ascertain conformance to the requirements of the ISO 14001 standard. To accomplish this, the audit will address the implementation of all the elements of the standard. Review of documentation and records to support the implementation is an expected part of the assessment process. If non-conformances or opportunities for improvement are identified they will be documented in a report which will be presented to the organization during the closing meeting. The report will include the auditor’s recommendation regarding registration.

Any deviation from procedures or requirements of the standard will be identified as an audit finding, which will be documented in the audit report. The auditor will draw your attention to non-conformities as they arise so there will be no “surprises” at the closing meeting. Findings are categorized into three categories defined as follows:

• A major non-conformity relates to the absence or total breakdown of a required process or a number of minor non-conformities listed against similar areas. A major non-conformity at the Registration Audit – Stage 2 would defer recommendation for registration until that major has been closed.

• A minor non-conformity is an observed lapse in your systems ability to meet the requirements of the standard or your internal systems, while the overall process remains in tact.

• An observation or opportunity for improvement relates to a matter about which the Auditor is concerned but which cannot be clearly stated as a non-conformity. Observations also indicate trends which may result in a future non-conformity.

Corrective Action Response

ISO 14001 Standards requires corrective action responses from all Registration Audits. Once certification is achieved, dependant upon the extent and nature of the findings, your organization may be required to submit a corrective action plan, detailing your intent to correct the non conformity.

The auditor may also recommend that your organization submit objective evidence to support the to verify closure may be required.

It is recommended that all non-conformities are addressed within your internal corrective action system. Typically, opportunities for improvement would be addressed as preventive actions by your organization.

closure of the finding. In certain circumstances such as a major non conformity an on site activity

Surveillance Audits

Company shall conduct Surveillance Audits on an annual or semi-annual basis. The purpose of the Surveillance Audit is to ensure that the EMS continues to conform to both the organizations’ and the ISO 14001 requirements. Certain processes will be reviewed at each surveillance including:

• Internal audits and management review

• Customer and interested parties communications

• Effectiveness of the management system in achieving defined objectives

• The progress of planned continual improvement activities

• Continuing operational control

• A review of any changes made by the organization which may have impact on the registration

• Use of accreditation and certification body logos provided to the organization upon registration

• objectives, targets and programs

• evaluation of compliance

Re-assessment Audits

The accreditation body requires that a recertification audit be carried out every three years. The purpose of the recertification audit is to confirm the continued conformity and effectiveness of the management system as a whole, and its continued relevance and applicability for the scope of activity.

Recertification audits review the performance of the EMS over the registration period, and include a review of previous surveillance audit records. The recertification audit includes the following:

• The continued relevancy of the organization’s policy and objectives

• The continued effective interaction between the processes of the management system

• A review of internal audits, management reviews, document changes during this certification period

Integrating Management Systems Within The ISO Standards

Today’s free market economies increasingly encourage diverse sources of supply and provide opportunities for expanding markets. Fair competition needs to be based on identifiable, clearly defined common references that are recognised from one country to the next. A standard, internationally recognised, developed by consensus among trading partners, serves as the language of trade. The International Organisation for Standardisation (ISO) has developed around 8’700, mostly technical related standards on this basis. Standards Series such as ISO 9000, ISO 14000 and what is to be known as ISO 18000 and ISO 26000 are Management related. These standards contain generic guidelines for Management Systems in the area of Quality, Environment, Occupational Health & Safety and Human Resources.

ISO is a word derived from the Greek isos, meaning “equal”. ISO Standards are developed and updated by the International Organisation for Standardisation which has around 150 member bodies. A member body of ISO is the national body “most representative of standardisation in its country”.(eg. Germany – DIN, USA – ANSI, Australia – SAA).
More than 50 countries, as well as the European Community have adopted ISO 9000 which is recognised internationally as a benchmark for measuring quality in a trade context. Since its first issue in 1987, approximately 430’000 companies have been using ISO 9000. Being a standard coming from an organisation that is usually involved in the development of technical standards, ISO 9000 is often regarded as a document that belongs in the hands of a technician exposed to production line quality control. At a closer look, however, ISO 9000 Standard Series provide guidance in the development and application of Management Systems as well as Quality Control in Manufacturing and Administration.

ISO has been developing a number of Management System Guidelines for various aspects of business. The most recent are the ISO 14000 Environmental Management System Guidelines. This is an international standard that will affect business in the near future. ISO 14000 has been designed to integrate with ISO 9000. However, apart from international standards there are local standards a company has to comply with. To remain compliant with local standards, further manuals and/or procedures are required (eg. lifting procedure in a warehouse to satisfy Work Safety requirements). A company may have several Manuals describing its Management Systems (eg. Human Resources, Quality, Security, Health/Safety, Finances). An overall link between the systems is often missing which makes the monitoring and the assessment of effectiveness difficult. Double handling of information, contradicting instructions, high maintenance costs, administrative excess and lack of overall transparency are common results.
ISO 9000 Standard Series for Quality (of) Management Systems provide generic guidance for the development of an overall Management System, ISO 14000 provides guidance for Environmental Management, etc. Transparency and monitoring of all business activities can be achieved by integrating all systems into one.
Complaints that ISO 9000 is paralysing operations and, that it does not reflect reality are usually a result of not clearly understanding how the standard can be properly structured to address the needs of a company. ISO 9000 can be structured by focusing on “best practice” process rather than the standard, by fitting the standard to the process and not the process to the standard. Having recognised this, ISO has been working on a new structure for ISO 9000, called “Vision 2000″, taking a process orientated approach to ensure that “best practice” as well as several standards can be addressed within one system. Focusing on process allows the development of a practical “working document”, providing an effective management tool. Having learned from the past, the trend to Process Orientated Management Systems started about three years ago in Europe and is finding increasing approval from certification bodies.Every company has its own culture and key individuals.
The business environment influences processes in certain ways (eg. employee market, laws, infrastructure, client, etc.)
To ensure competitiveness a company needs to ensure adequate flexibility in their system to effectively respond to changes in the business environment.
An effective system is a lean system that incorporates all necessary functions, controls of activities and “best practice” without being caught up in detail.
An effective system must also be flexible enough to enable the proper controls on outsourcing and sub-contracting of activities (eg. production, administration, service, etc.)