Table 1 Resource use items in the in-depth interview guide
Item | Description | Possible data source |
|---|---|---|
A. Quality Improvement Interventions | ||
Capacity building of personnel | Cost of capacity building/training for personnel | Financial records/interview/training and records |
Engagement of consultant/expert (e.g. validation/qualification of equipment, design of facility) | Consultancy fees and calibration cost | Financial records |
Recruitment of additional staff | Staff cost | Financial records |
Recalls | Logistics cost (cost of retrieval from market, litigation/penalties) | Interview |
Audit | Cost of carrying out audit | Financial records/interview |
Post-marketing surveillance (PMS) | Surveillance cost/cost of analysis | Interview |
Preventive maintenance | Cost of spares, contractor or service provider | Financial records |
Supply chain system (e.g., warehousing, delivery, vehicles) | 1. Cost of setting up or upgrading warehouse | 1. Financial records or estimate from a quantity surveyor |
2. Cost of maintaining quality storage or distribution of specialized products or materials | 2. Financial records | |
Product development | Cost of product development, stability chamber etc. | Financial records/interview |
Upgrade of facilities or acquiring new building/structures (e.g., building, HVAC, warehousing, equipment, analytical equipment, process, packaging) | Cost of upgrade or new acquisition | Financial records or estimates from a quantity surveyor/supplier |
B. Benefits of Quality Improvement | ||
Sales volume | Unit sold, monetary income from sale measure pre and post implementation | Financial records |
New business | Income from new business/customers | Sales records/financial records |
Internal failures including rework, out-of-specification (OOS),batch records, errors, omissions | Cost of man-hours, machine hour/operation cost, material/product cost associated with internal failures | Factory/laboratory logs and interview |
External failures including customer complaints, recalls, litigation, compliance directive by regulatory agency, cost of repeated inspections due to regulator’s quality concerns | 1. Cost of product replacement, man-hour spent on investigation and cost 2. Logistic cost, cost of lost products, cost of destruction, man-hour in collation and compilation of reports 3. Potential litigation charges 4. Default fees, fines | Financial records, factory logs, interview and standard regulatory agency default fees |
Potential new business | Potential to access new markets e.g. donor agencies, Ministry of Health (MOH), etc. | Willingness-to-pay by donor agency, MOH, etc. |