It could be described as the holy grail of quality management systems—that spectacular vision whereby any stakeholder from the executive to a reliability engineer to the account manager meeting with the customer can interrogate the quality management system. It can use, share, trace, approve, accept, or update a record or artifact and know that for all, this serves as the single source of truth (SSOT).
The vision is for the complaint, issue or indeed, opportunity (perhaps for improvement) to be unique in its own right as a data entity (or collection of entities) and for all associated information to be seamlessly linked, perhaps even summarized when one views a procedure, non-conformance, CAPA, audit finding, or training record.
SSOT is, in and of itself, the silver bullet to duplication of effort, poor visibility regarding challenges, their resolution, and verified effectiveness. The only way for an enterprise to achieve SSOT that spans the footprint of the organization and to have any confidence in it is to build using technology, specifically software like Enterprise Quality Management Software (EQMS) or other enterprise systems. Looking forward, Smart Connected Assets are the answer to the demand for SSOT. There are, however, some critical elements of EQMS and related platforms that if ignored or poorly implemented will stand in the way of the objectives related to SSOT and fact-based decision making.
Select Solutions with SSOT in Mind
Disparate quality systems and data sources remains the most consistent barrier to organizations achieving their quality management objectives. LNS’ multi-year survey grows by the day with thousands of respondents continuously affirming this fundamental obstacle. Even for one of the most heavily regulated industry groups, life sciences, this issue still persists as a top three problem. This is telling given the quality organizations within are historically very well-funded and often demonstrate a high maturity level in quality management systems. Regarding challenges while addressing top quality management objectives for life sciences, respondent results were:
- Quality is considered a department, not a responsibility-29.9%
- Quality metrics are not effectively measured- 26.3%
- Disparate quality systems and data source- 18.4%
- Lack of visibility into supplier quality- 10.5%
- No formal process for continuous improvement- 10.5%
- Lack of executive support- 5.3%
EQMS promises and delivers many benefits with the potential for solving the SSOT challenge being one that is very significant, but in order for the SSOT goal to be achieved there are three crucial requirements that demand strong answers from EQMS solutions:
- Process & Module Interoperability – This includes the seamless interface and intelligent linking of records within and across processes and modules of an EQMS. Examples include training and competence as it pertains to controlled documents like procedures and work instructions or findings from an audit as they relate to corrective actions or a training requirement or both.
- System Interoperability (typically referred to as integration) – The exchange of data between related systems such as a supplier/customer non-conformance or complaint as it pertains to a specific order managed in an ERP platform as well as an account managed in CRM, and also potentially impacts design considerations in PLM.
- Site/Business Unit Interoperability – This is the consolidated architecture that the system exhibits so that multiple sites/facilities or business units across regions in a global context can co-exist in, share, and exchange information without duplication.
Mature, well designed EQMS platforms exhibit sophisticated process and module interoperability. Many have developed and embedded core CAPA capability that allows for the launch of actions from within most or all other core processes. Automatic relationships are made when actions are spawned and linked to other entities, such as an action that demands the updating of a Failure Mode and Effects Analysis (FMEA) control plan or procedure or both is. This may be automatically (or at the user’s discretion) woven into a simple to follow trail. Supporting this functionality is the automated stamping of specific auditable trail of what was done, by whom, and when. When this is part of a configurable workflow with well-designed business rules, much of the potentially onerous challenge of the SSOT need is satisfied by automation with one important gap: the important relationship of SSOT with other sources of data resident in other platforms or systems.
The system interoperability provision from EQMS vendors varies across a broad spectrum from almost no integration outside of user/HR in flat-file format for scheduled import through to integration SDKs, sophisticated APIs, and Web service libraries. It is important to note that it’s unlikely any vendor will have out-of-the-box connectors for the entire landscape of systems your enterprise has in place. With this in mind, it is critical to identify what the most important sources of quality related data are, and for these be sure that the core contributors to the SSOT objective are accommodated. The core sources will generally be related to product data/product lifecycle management (PLM), supplier and customer ID, product codes, purchasing information and BoM/enterprise resource planning (ERP) and customer information relating to sales, service, and warranty (CRM).
Site and business unit interoperability is complex but pivotal for the SSOT vision, especially when the same product line is manufactured in multiple locations. Documentation is the best example where specifications, recipes, procedures, etc. are maintained and multiple potential risks and opportunities are experienced. The root of SSOT success depends on information, knowledge, and action based on consistent and verified or approved unique or appropriately related artifacts. The benefit of this is also seen in the widening of scope and ease of collaboration.
SSOT and the EQMS Hub
If we satisfy the basic interoperability and integration need, this allows the principle of your EQMS serving as the single source of truth for quality management to flourish, especially when other benefits of EQMS are leveraged. The EQMS offers harmonization across processes like training and competence management, audit, and management of change. EQMS also facilitates the closed-loop approach and drives visibility across the value chain.
Complaints are a good example of the benefits of SSOT built into an EQMS hub. When engineering, manufacturing, supply chain, sales, and customer services have visibility in a single platform (or mirrored automatically in their point of entry system—like CRM for sales and customer service or ERP for finance) there is robust and efficient resolution/communication across both internal disciplines as well as the external. The executive is served with data that is no longer a patchwork compiled manually; it can be derived from the EQMS with confidence. The quality engineer can interrogate, track, and manage issues effectively. This eradicates duplication, increases rigor, and adds the benefit of capturing and managing every record in the hub—contributing to overall organizational knowledge.
SSOT rolls off the tongue and most EQMS’ aspire to provide the right conditions and tools to achieve this difficult yet powerful and bountiful end state. Actually meeting the SSOT challenge, however, relies on some fundamental criteria being met around interoperability—criteria that should be satisfied in the early stages of EQMS selection. Integration nirvana could become a very expensive and, potentially, a project stalling miss-step. Focusing on the absolute must-haves and looking for proven in-application linkage, to start the journey on the right footing be sure to look for mature and well-designed integration layers or toolsets and suitable architecture considerations.
Understand the capabilities of twenty of the leading vendors in the APM space by downloading our APM Solutions Section Guide. The guide contains comparison charts for the factors listed above and the detailed profiles of the twenty vendors ranging from automation companies, to enterprise software providers and includes many specialized APM solutions as well.
Categories: Enterprise Quality Management System (EQMS)