Trimming the Fat: Simplifying ISO Management System Documentation.
For organisations entangled in the web of over-documented systems or seeking strategies to simplify their ISO management system documentation, a Lean approach might hold the key. Lean methodologies, often a beacon for efficiency, can be a game-changer in the creation and upkeep of documentation compliant with ISO Management System Standards (MSS) and regulations like 21 CFR 820 FDA.
Identifying Documentation Woes
Research from the Lean Enterprise Research Centre highlights that a significant portion, approximately 60%, of production activities in typical manufacturing operations are considered wasteful. Surprisingly, a similar if not more significant portion of waste may reside within conventional ISO management system documents. Common deficiencies found in these procedures encompass excessive length, poor articulation, complexity, redundancies, and outdated content.
The Lean Solution
A recent survey conducted across five organisations involving eighty-three management and supervisory personnel unveiled alarming sentiments. Almost unanimously, participants agreed that their procedures were overly lengthy, convoluted, and poorly articulated. Despite acknowledging these flaws, many organisations continue to wallow in convoluted and burdensome procedures.
The antidote? Embrace Lean principles.
Traditionally, businesses structure their management system documents in a pyramid fashion, typically comprising a manual or policy section at the top, followed by Standard Operating Procedures (SOPs), instructions, and records. However, the effectiveness of this structure is being reevaluated in the era of Annex SL, where no MSS necessitates quality or business manuals.
A Lean Approach in Action
Consider ISO 9001:2015's clause 8.4.3, which mandates information communication to external providers. Typically, this clause is replicated across multiple levels: the manual, SOPs, and finally, the records. However, a Lean strategy rethinks this hierarchy, prioritising efficiency and effectiveness.
By eliminating the verbose manual and ensuring that records encapsulate the essential details required by both the standard and the business, organisations can significantly streamline their documentation. In some cases, the need for a corresponding procedure can be rendered redundant by enhancing the record template, making the structure sleeker and more straightforward.
The Lean Commandments
1. Ditch the Manual or Opt for a Lean Version: Consider a three-page Lean Business Manual over the traditional hefty versions.
2. Enhance Records: Ensure that records encapsulate the requisite details to meet both standard requirements and business needs.
3. Consider Procedure Elimination: Assess whether certain procedures can be foregone if the records adequately fulfil the standard's requirements and organisational needs.
In summary, embracing a Lean approach to documentation streamlining can declutter your ISO management system, rendering it more efficient, focused, and aligned with both regulatory standards and business imperatives.
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