How Much Do You Love Your SOPs Part 1: Duplication
By Dee Carri
Read the introduction to our 'How Much Do You Love Your SOPs' blog series here >
It is well understood that consolidation of quality and compliance artefacts is good practice.
The reality is somewhat different. What we see in our day-to-day work is not just duplication, but multiple replication at every level; by organisation, by artefact and by governance activities.
1. Organisational replication
Departments, Business Functions, Operational Excellence, Business Units, Regions and HQ
2. Artefact duplication
A multiplicity of replication between and within Quality including:
Manuals, Policies, Guidelines, Standards, SOPs, Work Instructions and Training Materials
3. Replication of governance, by Compliance and Quality topic
Duplication of governance activities including:
Strategy, Planning, Implementation, Maintenance, Assessment and CAPA
And change management cycles by regulatory topic i.e.:
Product, Financial, Environmental, Safety, Privacy, Corporate Governance, Ethics etc.
The result of all of this duplication is a huge amount of avoidable waste.
Consider for a moment a situation where an organisation has three manufacturing plants, each with 1,000 SOPs, which is realistic for a mid-sized pharmaceutical plants. A study of the level of duplication has established a clear replication level of 40% for SOPs alone. (A not uncommon level of replication in our experience.) This replication percentage does not include replication of other non-SOP artefacts e.g. Finance and HR.
Each manufacturing unit has developed its own SOPs at a total cost of 51 man years each, or, a total cost of 153 man years. On this basis, we can say that replication costs this organisation a minimum of 61.2 man years relating to the once-off cost of SOP development.
And there's more. Recurring costs are also replicated:
Once developed, these 3,000 SOPs will need a support organisation for the management of on-going duplication!
The cost of inefficiency, rework, inconsistency and ambiguity arising from more than one way of working may be less visible but it may cause big problems in organisations where the regulations demand consistent, repeatable ways of working.
Given the clear and compelling case for change why are more organisations not fired up to remove this huge waste and cost? Our ongoing conversations with management and compliance and quality professionals provide some rare insights:
1. No-one owns this problem
Organisations are structured around functional silos and local silos, therefore cross-business, cross-functional and cross-governance oversight and leadership is missing. Until someone owns the problem, consolidation and rationalisation won’t happen at a strategic or enterprise level. The question is where - within the organization, and who – what role, should own this problem?
2. Denial: Organisations don’t want to know the cost of replication
Exposure of the level of replication could reflect badly on the individuals who created replicate artefacts so, whilst the problem is well-known and understood, those in charge find it more expedient to ignore it and live with the consequent inefficiencies.
3. Resistance to change: Loss of autonomy and power
Consolidation may be viewed as a threat to the autonomy and power of Quality and Compliance organisations and local management teams, making them less supportive of this type of initiative. They will cite a myriad of reasons for this resistance such as loss of local flexibility being unacceptable or local legislation making them a special case.
4. Resistance to change: The Quality and Compliance function is a sacred cow
Quality and compliance organisations generally own quality and compliance governance processes and artefacts. They are unused to scrutiny of their own practices and whilst they may participate in lean and quality programmes in the rest of the organisation, they are unlikely to be in-scope themselves. The result is that many quality and compliance processes are not lean and their practices are out-dated and inefficient.
5. Resistance to change: Fear of failure
Many organisations are paralysed by fear of failure – they are terrified of creating additional risks to their regulatory status and therefore resist any change to current practices.
6. Supporting infrastructure
The typical infrastructure supporting text-based procedures is inadequate and cannot support a text-based document consolidation initiative, for example:
It is not possible to see end-to-end processes, making it difficult to spot replication.
Collaboration is limited to tortuous and semi-manual mechanisms, requiring a big physical input by all participants. This is particularly challenging where cross-functional and multi-location collaboration is required.
Quality and Compliance professionals are too busy trying to keep up with firefighting and their day-to-day workload and therefore do not have time to take on strategic improvement initiatives and can also result in poor planning, poor training and/or poor management of SOPs.
Conclusions and Solutions
Duplication of SOPs, Work Instructions and other quality and compliance artefacts cause large amounts of waste within organisations and there is a big opportunity for significant savings where this waste is removed.
In order to achieve these savings, organisations will need to change their current approach, moving to a top-down, cross-functional and process-centric view of its artefacts, rather than a piecemeal or silo approach.
A practical starting point for those organisations wishing to understand the size of the “replication” prize is to expose the level of replication in the organisation, and its cost. To by-pass resistance and other impediments, this short exercise needs to be sponsored by Senior Manager at Enterprise level.
The exposure of the scale of replication and associated redundant processes will result in a compelling case for change.
In the next blog in our SOP series, we'll focus on the topic of “defects”. And if you missed the introduction, you can find it here >
In the meantime, we invite you to provide feedback, comments and your experience in the comments section below.