UNCONTROLLED IF PRINTED TERHAD

PU 2103

TECHNICAL AIRWORTHINESS MANAGEMENT MANUAL

SECTION 3 LEAFLET 6

HOW TO PRODUCE APPROVED DESIGNS

Applicable Regulations: 3.4 Design Control INTRODUCTION 1. For any design to be incorporated with respect to State aircraft it must be accepted by a Design Acceptance Representative (DAR) in accordance with the requirements of Regulation 2. These regulations give the DAR considerable latitude to accept a wide variety of designs with varying levels of personal involvement and rigour as the situation demands. Whilst there are some exceptions, in general, all designs must be approved by an ASR before they can be accepted. Therefore, the process of producing an approved design is central to the assurance of technical airworthiness and thus is subject to TAR Regulations. 2. The regulations require that ASR performing design institute a design control system that ensures: a. the design is approved in accordance with the regulations; and

b. design outputs produced by the AEO meet, and are shown to meet, the design requirements. PURPOSE 3. The purpose of this chapter is to provide Authorised Engineering Organisations (AEOs), and in particular Senior Design Engineers (SDEs), with guidance as to how they can produce approved designs able to be approved by ASR and accepted by DAR. As the focus of this chapter is on achieving Design Approval, rather than performing design, it is presented in a way many perceive as backwards. The chapter will start with a definition of an approved design and step through the design process in reverse order until design development. SCOPE 4. The basic process requirements for generating an approved design for use on a State aircraft are independent of the scope of the design. Hence this chapter applies to all organisations responsible for the conduct and/or management of engineering which leads to the production, or acceptance, of Approved Designs, whether those designs are for a new O-ring or a new aircraft. Although the steps described in this chapter are part of the Design Acceptance process, refer to Chapter 7 for information regarding Design Acceptance. It must be noted that where any conflicts occur between the guidance and the regulations, regulation takes precedence. WHAT IS AN APPROVED DESIGN? 5. If only approved designs can be accepted, just what constitutes an approved design? The simple, and rather trite, answer is that an approved design is any design that has been issued Design Approval certification (Regulation 3.4.3). The more complex, and useful, answer is that an approved design is a design which has been issued a Design Approval certificate and which conforms to all the process and documentation requirements of the www.dgta.gov.my 3.6 - 1 of 12 TERHAD

UNCONTROLLED IF PRINTED TERHAD

PU 2103

relevant regulations. There are quite a number of these regulations and it is the purpose of this chapter to pick them out and describe how they might be satisfied. Broadly, for a design to be approved, it must: a. b. have been subject to independent review; comply with the relevant specification;

c. have been shown to comply with the relevant specification after some verification activity; d. have been developed in accordance with the ASR approved systems and procedures; and e. be fully documented.

Who Can Approve a Design? 6. Who may approve a design depends on two things: a. The Significance of the Design. The regulations consider all designs as being in one of two categories, significant (high risk) and non-significant (lower risk). The judgement of the significance of a design is a step that is initially taken during the design planning stage and repeated at intervals later in the design process, to ensure the initial assessment was correct. The principle effect of this judgement is to raise (or lower) the level of authority required to review and approve designs, and the rigour expected of the design and design review processes. The Judgement of Significance is discussed in more depth from paragraph 33. b. The Authorisations of the Persons in the AEO. The regulations require that persons within AEOs must be authorised to do any engineering activities they may undertake as part of their duties. Authorisations are given in terms of a level and a scope. Therefore, persons may only approve a design if they are authorised to (at least) the level of design approval. Further, the design must fall within the scope of the persons authorisation. For instance, an avionics DE may not perform design approval for a structural design. 7. Significant Designs. In general, the SDE of an AEO is required to personally approve all designs judged as significant. However, the regulations recognise that this may not always be necessary or appropriate, so they provide three ways for personnel other than the SDE to perform this function as follows: a. Regulation 3.3.2.b allows an AEO the option to establish Deputy SDEs (DSDEs) with authority to perform assignment of internal EA functions, as well as SDE design control functions in accordance with Regulation 3.4. DSDEs are required to meet the same criteria as an SDE, and are approved by the TAR as for the SDE. A DSDE is therefore able to approve a design judged significant within the level and scope of their appointment. b. Regulation 3.4.3.a(5) specifically identifies the case where the SDE may authorise specific DEs to approve certain classes of design. If the SDE authorises a DE in this way then the SDE is then required to review the DEs Design Approval decision as soon as practicable. Note the regulations do not mandate the content or timing of this review. The AEO is required to have a procedure describing the content and timing of the SDEs review of DE Design Approval decisions. The TAR as part of the general compliance assurance process will assess this procedure for the AEO. www.dgta.gov.my 3.6 - 2 of 12 TERHAD

UNCONTROLLED IF PRINTED TERHAD

PU 2103

c. Regulation 3.4.3.a(4) creates a third option, not explicitly stated but allowed by the phrase except as otherwise authorised by the TAR. Large organisations, generally commercial AEOs with many diverse contracts, have a need to be able to allow at least one DE in particular sections or divisions to exercise all the Design Approval authority normally invested in the SDE (without subsequent SDE review of decisions). In these cases the applicant for engineering authority can give this authority to a DE as long as this is clearly shown in the applicants EMP. Where an organisation seeks to give this authority to a DE, the TAR requires that person to satisfy all the criteria normally applied to an SDE. 8. Non-Significant Designs. Design Approval of designs judged to be non-significant may be performed by competent (ie suitably trained, qualified and experienced) personnel with a level of authority less than that of DE who have been authorised by the SDE or a DSDE (if applicable) to do so. How is an Approved Design Identified as Such? 9. A design is identified as having been approved by the release of Design Approval certification, often shortened to simply a Design Certificate. The TAR has not mandated a format for this certificate and recognises that the format will need to be tailored depending on the size and complexity of the design task. Nevertheless, the TAR has mandated a minimum level of information to be included on all Design Approval certifications, namely a complete: a. list of the specifications, standards and other requirements to which the design was developed; and b. index of design documentation including instructions needed for assuring the continuing airworthiness and integrity of the design.

INDEPENDENT REVIEW OF DESIGNS 10. No matter how simple (replacement of o-ring xyz with o-ring xyz-1) or complex (an AEW&C system) a design may be, all design outputs comprising that design shall be subject to independent review. The TAR recognizes that for complex designs it will probably not be possible to review the entire design upon its completion, so the regulations talk in terms of design outputs. These outputs could be sub-system specifications, software code, and drawings or test results. Figure 61 shows how the concept of Design Review could be applied to both simple and complex design cases.

www.dgta.gov.my

3.6 - 3 of 12 TERHAD

UNCONTROLLED IF PRINTED TERHAD

PU 2103

Figure 61 Example of Both Simple and Complex Design Review Processes What Does Design Review Do? 11. All engineers are human and all humans make mistakes. No matter how simple the design or how qualified and hardworking the engineer, occasionally mistakes will be made. The purpose of Design Review is to find those mistakes and correct them before a design is incorporated. Thus the design reviewer must ensure the following: a. The design assumptions, design data, design conditions and the method and tools employed in developing the design solution must be appropriate and valid. For example, if the designer assumes that a box uses a standard logic arrangement, the design reviewer should ensure that it is valid, as the maker of that box may use a unique logic that would lead to the box behaving incorrectly. Similarly, if the designer has referenced a stressing report from 1965, the design reviewer should ensure that the report is still valid given the myriad of changes that may have occurred to the aircraft since then. b. Any calculations or analyses conducted in developing the design output must be properly conducted and correct. The Design Review may simply check the numbers or could try and repeat the entire analyses to determine that the developer performed these tasks correctly. The extent of this aspect of the review would depend greatly on the significance and complexity of the design and needs to be determined by the reviewer on a case-by-case basis. c. The design outputs must meet their input specifications. This would appear obvious, however it is important to check that all the input requirements, especially those that may be hidden in referenced standards, be satisfied. d. The verification results must demonstrate that the design outputs comply with their input requirements. Often specification requirements require some modelling of the actual requirement such that a realistic (and affordable) test may be performed. Once the test is complete, the test results will in turn require interpretation back to the actual requirement to determine compliance. This situation introduces a number of areas where the results of tests may not actually demonstrate the compliance of the design with the original high level requirement. It is the role of the design reviewer to detect such anomalies. www.dgta.gov.my 3.6 - 4 of 12 TERHAD

UNCONTROLLED IF PRINTED TERHAD

PU 2103

12. It must be noted that Design Review is not the stage at which redesign is done to correct errors or where design documentation is completed. To do either of these things eliminates the independence of the review and lessens its value considerably. This issue is discussed in greater depth below. Who Can Do Design Review? 13. Who may review a design depends on: a. b. the significance of the design; and the authorisations of the persons in the AEO.

14. Significant Designs. Design Review of designs judged to be significant may only be performed by competent (ie suitably trained, qualified) personnel, with a level of authority of DE, who have been authorised by the SDE or a DSDE (if applicable) to do so. NOTE
Where the design involves many disciplines the TAR requires that either a person or team authorised to act in all those disciplines conduct the Design Review. For example, the installation of an additional radio system into an aircraft will require not only avionics specialisations but also structural specialisations for the mounting of the radio control panel, R/T unit and antenna.

15. Non-Significant Designs. Design Review of designs judged to be non-significant may be performed by competent (ie suitably trained, qualified) personnel, with a level of authority less than that of DE, who have been authorised by the SDE or a DSDE (if applicable) to do so. NOTE
Where the design involves many disciplines the TAR requires that either a person or team authorised to act in all those disciplines conduct the Design Review.

16. Independence of Reviewers. The key to ensuring that a design is properly reviewed is that the reviewer must not have been involved in the original design work. Thus the regulations require that persons reviewing design output may not have participated in the development of that output. In general this requirement is relatively straightforward and easy to implement. In complex designs, however, the design may move between development and review a number of times and it can be problematic to determine just when the reviewers might lose their independence and should no longer act in that role. Similarly, in small organisations it can be impossible to find sufficient engineers to maintain complete independence. For this reason the TAR has not sought to regulate this matter and will rely upon the judgement of those performing the activities in the field. 17. As a guide, the TAR expects that for most cases design reviewers will not correct errors or complete design documentation, but rather point out errors or missing documentation and return the design to the developer for correction or completion. However, the issue can be far more subtle than that and reviewers can become overly involved in the design simply by providing too much direction to design developers. For example, should a reviewer disagree with the assumptions, methods, tools or data used by the developer it can be easy for the reviewer to be drawn into telling the developer what to do, thus in effect doing part of the design. This problem can often arise where the reviewer is more senior than the developer in the organisations hierarchy and where the reviewer also has some mentoring or development responsibility for the developer. As said in the earlier paragraph, the dividing line between review and development can be quite difficult to detect and thus the TAR has not attempted to regulate it in detail. Rather, individual reviewers must exercise their professional judgement to ensure the review remains independent and effective. www.dgta.gov.my 3.6 - 5 of 12 TERHAD

UNCONTROLLED IF PRINTED TERHAD Additional Review Requirements

PU 2103

18. For designs judged as significant, the TAR requires that at least two sets of professional engineering eyes oversee the design, a set of professional eyes being defined as those belonging to a DE. Therefore, where a significant design is developed by a DE and then reviewed by a DE the TARs criterion has been met and the design can proceed to Design Approval. Where a design judged to be significant has been developed by a person below the level of DE, it must receive formal Design Review, firstly by a DE. Following this, Regulation 3.4.4 requires the SDE to conduct second level of review. As part of this review, the SDE or a DSDE (if applicable) is to ensure that: a. the persons performing the design development and Design Review were competent for the task; and b. the design assumptions, design data, design conditions and the method and tools employed in developing the design output were appropriate and valid. 19. It should be noted that this second level of review is not intended to be another check of the numbers or a documentation check, but rather is intended to ensure that the fundamentals of the design development were correct. In addition, the SDE or a DSDE (if applicable) is required to consider the competency of the design developer and reviewer. DEVELOPING THE DESIGN Design Control System 20. The regulations require that organisations performing design shall institute a design control system. As well as ensuring that the design is approved in accordance with the relevant regulations, there are a number of requirements that apply to the design development process. These process regulations are to ensure that: a. b. design development is conducted by authorised persons, the design development process is planned,

c. all organisational and technical interfaces are identified and considered by the design process, d. the specification for the design has been reviewed,

e. the data to be used in support of the design process is applicable and accurate, f. g. h. the significance of the design has been judged and recorded, the design output meets the specification criteria, and the compliance of the design output with the specification has been verified.

Persons Performing Design Development 21. Design development can take so many forms and cover such a wide variety of activities that the regulations would not be able to adequately define the classes of people able to perform each of them. Therefore, the regulations rely on the AEOs to determine who may perform design development activities and then simply require that the AEO ensure that only people authorised to undertake design work do so. www.dgta.gov.my 3.6 - 6 of 12 TERHAD

UNCONTROLLED IF PRINTED TERHAD Design Plans

PU 2103

22. All design development activities are to be planned and conducted in accordance with the plan. The design plan is intended to: a. describe the design activities to be undertaken under the plan (this description should include, at least, reference to the specifications and standards the design is to meet, the tools and data to be used, and the design and verification methods to be employed); and b. assign responsibility for the conduct of all the activities to be undertaken under the plan. 23. The design plan should be a living document, updated as the design evolves, so that it remains relevant to the design process. For example if, as the design progresses, the Judgement of Significance is changed for any reason, then the design plan should be updated to reflect the change, and reasons for the change. Similarly, if the personnel, data, tools or any other aspect of the design described by the plan are changed, then the plan must be updated to reflect those changes. 24. Approving the Plan. The regulations require the plan to be approved by the person who will approve the design. At first glance this may appear difficult to implement, particularly for complex designs which are developed over a long period of time. For example, a design for a fast-roping device for a helicopter may evolve over several years with the final design approver being posted into the design agency long after the original plan was developed and only shortly before the design is complete. In this case it would seem impossible for the design approver to approve the plan. However, it must be noted that the regulations do not state when the design plan is to be finally approved. In fact, given that the plan is intended to be a living document, changing as the design evolves, it is expected that the design plans final approval will be given at the same time as Design Approval. This would ensure that the regulation requiring the design approver to be satisfied that the design was developed in accordance with all relevant systems and procedures was met, since the final plan should provide the necessary evidence. 25. Format of the Plan. The regulations do not specify a format for the design plan. There will be instances where the regulations are not satisfied by one document, but rather a number of plans, authorisations and procedures that collectively comprise the design plan. For example, the TAR does not expect simple substitutions to each have an individual design plan. In this case the design plan would comprise the agencys procedure for substitutions and the duty statements of the persons performing those substitutions. At the other end of the scope and complexity spectrum, major projects could have numerous plans addressing different stages and aspects of the design activity. For example, a project may have numerous separate plans at system and component levels that each address different design issues such as hardware design, software design, integration, systems engineering, test and evaluation and so on. What the TAR requires in all these circumstances is that the AEO identify in its EMP how it will satisfy the design planning regulation. 26. Note that the use of computer based decision recording tools such as Emerald do not, on their own, constitute a design development plan, as they fail to provide evidence that planning occurred prior to the design development starting. Further, unless the AEO requires specific information to be recorded in the comments or justification areas of the computer based system, elements of design planning may be missed out. For some classes of design changes, records of a brainstorming session or a team meeting in which the design development plan was agreed upon, together with the Emerald (or equivalent) records documenting the Judgement of Significance of the design, may meet the TARs requirements for design development planning. In each case, the specific requirements of the regulation (summarised at paragraph 22) are to be met. www.dgta.gov.my 3.6 - 7 of 12 TERHAD

UNCONTROLLED IF PRINTED TERHAD Interface Identification

PU 2103

27. One of the areas in which designs traditionally fall-down is the integration of the design with other designs or the existing equipment and systems. Given that poorly designed interfaces may introduce significant technical risk, the regulations require that organisations identify all technical interfaces for the design and the design development process. 28. The TAR also requires that organisational interfaces are identified. This aspect of the regulations is particularly relevant for instances where an AEO has relied on another AEO or DSN member to develop the design. Clearly, where a design has been developed across organisational boundaries, the AEO must document the organisational interfaces, including the arrangements by which information is documented, transmitted and reviewed. Specification Review 29. The actual development and approval of specifications is a Design Acceptance activity, thus this is not described in this chapter. However, the interpretation and implementation of those specifications is the essence of the design process. It is therefore imperative that the design agency ensures it shares a common understanding of the specification with the customer and that the specification provides sufficient guidance to the design agency to allow it to develop the design. Data Management 30. Any design is only as good as the design reference data upon which it is based. It is essential, and the regulations mandate, that design agencies have a procedure in place to ensure that data used to support the design process is up-to-date and accurate. For example, when using stressing reports for aircraft the design agency must have a system to ensure that those reports are still accurate and have not been affected by the numerous repairs and modifications and it will almost certainly have incorporated during the aircrafts life. Similar considerations may apply to reports such as system safety, thermal loads and other analyses forming part of the design reference data of the aircraft. 31. The TAR has not mandated any particular system for achieving this outcome. The configuration management processes defined in standards such as MIL-STD-973 provide a guide as to how this may be achieved, but these may not be appropriate for some organisations. The TAR will accept any tailoring of the systems defined by these standards (or equivalent) that satisfy the basic criteria that design data be relevant to the design. Design Outputs Meet the Specification and are Verified as Doing So 32. The design control system must ensure that designs meet the specification for that design and are shown to do so. Like every other part of the Design Acceptance process the procedures associated with verifying that the design meets the specification must be tailored to the scope and significance of the design in question. Simple designs, such as substitutions, may have a quick comparison of the specifications of the components to crossreference the requirements, with the verification relying solely upon testing the manufacturer may have performed. On the other hand the development of a system comprising multiple components, many designed within the design agency, would require a substantial requirements cross reference matrix, probably hosted on a specialised computer tool and supported by a comprehensive test program.

www.dgta.gov.my

3.6 - 8 of 12 TERHAD

UNCONTROLLED IF PRINTED TERHAD JUDGEMENT OF SIGNIFICANCE

PU 2103

33. A fundamental principle behind design control is that engineering rigour and expertise is applied to activities commensurate with the significance of the design change involved. The significance of a design change can be resolved into any number of degrees, but the regulations only require two degrees of significance. Thus, design changes are referred to as either significant or non-significant. The latter does not imply no significance (every design change will have some degree of significance), rather a level that does not warrant the additional engineering rigour and expertise that is required for significant design changes. 34. The significance of a design change (significant or non-significant), is to be judged as early as possible by an authorised person prior to Design Review (since the significance will have a bearing on who is authorised to perform Design Review in accordance with the regulations). As a result of Design Review, however, a designs significance may be upgraded or downgraded as appropriate. It is possible therefore that a design may be developed and reviewed several times prior to Design Approval and Design Acceptance in the case that the significance of the design has changed. NOTE
Care must be taken to ensure that any Judgement of Significance made in the very early stages of a design change proposal remains valid once the proposal is fully developed. Where a design is changed to nonsignificant, the decision record must include a statement justifying that decision.

35. Judgement of Significance is performed by determining both the consequence and probability of partial performance or failure of a design. The combination of these assessments is generally determined by a matrix that provides the corresponding significance result. 36. Relationship between consequence and probability. Regulation 3.4.5.a.(6) covers three instances in which the consequence of partial performance or failure of a design should be assessed as high. The design is not necessarily to be judged significant, as this depends on the overall probability of failure or partial performance of the design. The design may still be judged non-significant if the probability of partial performance or failure is low. 37. Regulation 3.4.5.a.(7) requires that the probability of partial performance or failure of a design be assessed as high if the design change requires comprehensive justification, assessment and verification. This is because a complex design involves more design assumptions, development work, verification, decisions, judgement, and consideration of factors involved. An omission or error in the design is therefore more likely (ie. there are more things that can go wrong). In this case, it is likely that the design is judged significant, since the consequences arising from a complex design are generally more serious as well. 38. In the case of a complex design (as shown in Figure 61), it is acceptable for individual design activities to have individual judgements of significance performed, in addition to the significance judgement for the whole design. In this case, Design Review and Approval of the individual activities may be performed according to their individual significance. Design Review and Approval of the entire design is to be performed according to the overall significance of the design, noting that: a. any individual design activity judged to be significant would normally cause the overall design to be significant; and b. even in the event that all individual design elements are judged as nonsignificant, their cumulative effect may cause the overall design to be significant. www.dgta.gov.my 3.6 - 9 of 12 TERHAD

UNCONTROLLED IF PRINTED TERHAD

PU 2103

39. Who can Make a Judgement of Significance? In general, a Judgement of Significance shall only be performed by (at least) a DE. The SDE is to ensure that local procedures provide adequate control and clearly define the applicable conditions and limitations (eg. technical substitution process). Persons authorised by the SDE or a DSDE (if applicable) shall only make decisions within authorised limits, the limits of available supporting data, and within their self-assessed level of competency. 40. Regulation 3.4.5.a(2) allows for non-DEs to perform Judgement of Significance, providing that the decision process is well defined, and the exercise of professional engineering judgement is not required. Should SDEs choose to authorise staff below the level of DE to perform Judgement of Significance, evidence and justification must be provided that the Judgement of Significance process at the AEO is not compromised. Specifically, significant design changes must not be mistakenly passed through the system as non-significant (and hence not receive the appropriate degree of engineering rigour). 41. By way of guidance, the TAR would normally expect that such an arrangement would only be used for simple classes of design change such as substitutions, and would only apply for selected staff deemed to be suitably experienced and competent. Further, the TAR would expect that the exercise of professional engineering judgement criteria is replaced with specific instructions provided to individual personnel. Particular attention should be paid to circumstances in which these personnel judge a design change as non-significant. THE ROLE OF THE DSN IN PRODUCING AN APPROVED DESIGN 42. The role of a DSN member in producing an approved design will depend on its status. The SDE is required under Regulation 3.3.3 to document in the AEOs EMP how each DSN members services are to be treated, and when they are to be sought. Generally, any DSN member is able to perform design development, including the design development plan. Judgement of Significance and all activities from Design Review onwards may only be performed by an AEO or persons assigned internal EA by the SDE. With respect to this chapter, the role of each DSN member is therefore one of the following: a. Able to undertake design development. In this case, designs or other TI are generally treated as advice (Expert Advice etc.). The DSN member is not an AEO, and therefore any services, designs, or TI provided must be subject to TIR, Judgement of Significance, Design Review and Approval, by an AEO with applicable scope. b. Able to provide Approved Designs (in addition to TI and any other advice). The DSN member is an AEO or meets the requirements of Regulation 2.5.6.c for Design Acceptance from a non-AEO. An Approved Design provided by a DSN member of this type may be immediately considered for Design Acceptance certification providing the design: (1). is within the level and scope of AEO certification (or other agreed services, such as an OEM) of the DSN member; and (2). meets the requirements for Design Approval, in that a Design Approval certificate has been provided by an appropriately authorised person (ie. not an email from the OEMs Field Service Representative recommending a course of action). 43. In the case of a non-AEO, in accordance with Regulation 2.5.6.c, the DAR is required to determine the required equivalent documentation to a Design Approval certificate, such as: a. NAA or UK/US FMS approval and release documentation; or 3.6 - 10 of 12 TERHAD

www.dgta.gov.my

UNCONTROLLED IF PRINTED TERHAD

PU 2103

b. OEM documentation indicating approval and release by a suitably appointed and qualified engineer within the OEM company. 44. All of the considerations described above are precisely the requirements an SDE must consider and document in the AEOs DSN for staff to follow. 45. Example. Section 3 Chapter 4 Annex A provides an example DSN table for the fictitious XXSPO organisation. In this example, CAESE, DGTA, and Upgrades R Us are AEOs, and hence they are able to provide Approved Designs within their scope of EA. Laser Aeronautics and Thruster America are OEMs, and hence minor designs may be passed for Design Acceptance certification under Regulation 2.5.6.c. The SDEs guidance to staff is that they are to be treated as Approved Designs. Note that information originating from the Field Service Representative (FSR) for Laser Aeronautics may only be treated as an Approved Design if it has evidence of endorsement by Laser Aeronautics USA. STRIDE is not an AEO, hence all designs and advice are treated as TI. The M-XX-AAU BAe and M-XXMFD USAF are also neither an AEO nor an OEM, hence their designs and advice are also treated as TI, even if the information originated from an OEM. This is because the configuration, role, and environment requirement of Regulation 2.5.6.c is not satisfied. In other words, since there are configuration differences between the SAO and BAe and USAF variants of the M-XX, the SDE wishes to ensure that staff do not assume that designs provided by the BAe and USAF are directly applicable.

Annex: A. Design Control Flowchart for Minor Changes to the Type Design

www.dgta.gov.my

3.6 - 11 of 12 TERHAD

UNCONTROLLED IF PRINTED TERHAD

PU 2103 Annex A. Sect 3 Chap 6

NOTES: 1. Initial Judgement of Significance (JoS) should ideally be determined at the Design Development Planning stage, but must be carried out prior to Design Review. JoS may be reviewed at any stage prior to Design Acceptance. If the JoS is changed from nonsignificant to significant, the Design Development Plan is to be reviewed, then start the process again. 2. This may be the same person who reviewed the design. NOTE As per Reg 3.3.2.b(2), the DSDE may perform all Design Control functions prescribed by Regulation 3.4. The Reviewer must always be independent of the Developer, as required by Regulation 3.4.4.a (5). The Approver should be independent of the Developer. Figure 6A1 Design Control Flowchart for Minor Changes to the Type Design (Sheet 2 of 2)

www.dgta.gov.my

3.6 - 12 of 12 TERHAD